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Shape Memory Alloys Explained

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TECHNOLOGY EXPLAINER

Shape Memory Alloys
— transformation temperatures are numbers about how an alloy was made and measured, not numbers about “the material”

Nitinol (Ni–Ti) is an alloy with two linked abilities: the shape memory effect, in which it recovers its shape when heated, and superelasticity, in which it springs back after large strain under load. The FDA’s guidance on nitinol notes that its transformation temperatures are sensitive to small variations in temperature or heating time during manufacture, and recommends measuring them on the final finished form, from at least three production lots where possible. In a NiTi-20Zr alloy, changing the Ni content by only ±0.2 at.% gave very different transformation temperatures and very different responses to aging. This article sets out, from primary sources, the mechanism of the transformation, what moves the transformation temperature and the superelastic stress, fatigue, Cu-based, Fe-based and high-temperature alloys, uses in medical devices, aerospace and actuators, and how to read the evaluation standards. It gives no medical advice.

Built from peer-reviewed papers (Science, Materials, Metals, Nature Communications and others), FDA guidance and a regulatory science tool, NASA technical reports and the JISC JIS search / Checked 10 October 2026

A deformed wire returns to its memorized shape on heating
Fig. 1 Conceptual image generated with ImageGen. A deformed wire returns to its memorized shape on heating. Three states represent one specimen at different times; transformation temperatures are not specified. Not actual facilities, products or measured results.
What this article covers
  1. What shape memory alloys are (the short version)
  2. Mechanism — a reversible transformation between two crystal structures
  3. What moves the transformation temperatures — composition, processing, aging, cycling, measurement
  4. How superelastic stress changes with temperature
  5. Fatigue — read it with strain amplitude and number of cycles
  6. Cu-based, Fe-based and high-temperature shape memory alloys
  7. Applications and how they are evaluated — medical devices, aerospace, actuators
  8. Limits, and what we could not confirm
  9. How to read the evaluation standards
  10. Glossary / References / Claim-to-source audit
Notation used in this article

Sourced = stated in a published source (with a link)
Our calculation = a value this article computed from stated assumptions
Not yet confirmed = plans or intentions with no confirmed results
Readings of materials design are marked as commentary. Inference is shown in bold.

How to read the numbers in this article

The transformation temperatures, stresses, strains and lifetimes here are results that specific papers or documents obtained for a specific composition, heat treatment, test temperature and test method. They do not describe mass-produced products or other alloys. For medical devices that use nitinol we only explain the position of regulatory documents and standards; we give no medical advice and no judgment on the safety or ranking of any product.

1. What shape memory alloys are (the short version)

  • An alloy that moves between two crystal structures: nitinol is an alloy of nickel and titanium in nearly equal atomic proportions, and it undergoes a reversible transformation between a high-temperature phase (austenite) and a low-temperature phase (martensite). Driven by temperature it gives the shape memory effect; driven by stress it gives superelasticity (pseudoelasticity) Sourced [Ref. 1]
  • The transformation temperatures move with composition, processing, heat treatment and cycling: the introduction of a review states that in shape memory alloys in general a composition change of 1 at.% can shift the transformation temperature by about 100 K. In Ni–Ti too, aging and thermal cycling move the values Sourced [Ref. 8, 6, 9]
  • Evaluation standards are mainly JIS H 7xxx and the ASTM F series; ISO, IEC and IEEE standards could not be confirmed: even for the transformation temperature alone, thermal analysis and bend-and-free-recovery need not give the same value Sourced [Ref. 1, 32]
The single most important line in this article

A number such as “Af is 20 °C” means something only when it states which composition and heat treatment, which method (thermal analysis or bend and free recovery), and whether it was measured on the final finished form or on the raw material.

2. Mechanism — a reversible transformation between two crystal structures

Nitinol is a nearly equiatomic Ni–Ti alloy. The FDA guidance explains that its properties come from reversible transformations between austenite and martensite, which can be induced by temperature (shape memory) or by stress (pseudoelasticity) Sourced [Ref. 1]. As for crystal structures, the review by Wang et al. says that, depending on thermal or mechanical conditions, the alloy can be B2 austenite, B19′ martensite (monoclinic) or the rhombohedral R-phase Sourced [Ref. 10]. Shamimi et al. likewise treat transformations in which the R-phase appears between the B2 parent phase and B19′ martensite [Ref. 6].

The transformation temperatures are defined separately for cooling and heating. On cooling, the temperature at which the high-temperature phase starts to turn into martensite is Ms and the temperature at which it finishes is Mf. On heating, the temperature at which martensite starts to revert is As and the temperature at which it finishes is Af. For two-stage transformations with an R-phase in between, the definitions are given in terms of the R-phase (the FDA guidance reproduces the definitions) Sourced [Ref. 1].

Upper: shape recovery on heating after deformation
Fig. 2 Conceptual image generated with ImageGen. Upper: shape recovery on heating after deformation. Lower: superelastic recovery on unloading. The operations and applicable temperature ranges differ. [Ref. 1, 10, 6] Shapes, colors and dimensions are illustrative. Consult the original schematic below for exact values and annotations.
View the original SVG schematic and exact annotations
Shape memory effect and superelasticity: one transformation, driven by temperature or by stress Conceptual; no numbers. Ms and Mf are the start and finish of the transformation on cooling; As and Af on heating. A Shape memory effect (temperature restores the shape) High-temperature phase Above Af; original shape (B2) Low-temperature phase Below Mf; shape is almost unchanged Deformed martensite Deformed by stress; shape stays after unloading Original shape returns Reverse transformation between As and Af (unconstrained) Cool Deform Heat B Superelasticity (stress restores the shape; above Af) Austenite Temperature above Af; original shape Stress-induced martensite Transforms under load; large deformation Austenite Reverse transformation on unloading; shape returns Load Unload The same B2 to B19′ transformation can be driven by temperature or by stress. An R-phase may appear in between * Phase names and transformation types follow the FDA guidance, the review by Wang et al. and the paper by Shamimi et al. * The bars are symbols for a change of shape, not cross-sections. Crystal structure and twin arrangement are not drawn.
Fig. 2 Conceptual diagram (vector drawing). The shape memory effect (temperature) and superelasticity (stress) shown as two ways of driving the same transformation, as our own figure [Ref. 1, 10, 6]. The bars are symbols for a change of shape, not real crystal structures.

Superelasticity is the phenomenon in which, above Af, applying a force triggers the transformation and a large deformation, and removing the force makes the reverse transformation return the original shape. In the stress-strain curve a “plateau”, over which the stress is nearly constant, appears while the transformation proceeds, and the plateau on unloading is lower than on loading (Fig. 3). The FDA guidance also notes that the region of near-constant stress is why mechanical testing is commonly done under displacement control Sourced [Ref. 1].

Stress-strain curve shapes: superelasticity and shape memory Conceptual, not measured data. No axis values are shown. A Superelastic (above Af) B Shape memory (below Mf) Strain Stress Forward transformation (upper plateau) Reverse transformation (lower plateau) Enclosed area = dissipated energy Strain Stress Detwinning plateau Residual strain Heating (As to Af) recovers it * The upper-plateau stress is the stress at which the transformation starts; it rises with test temperature (Section 4). * Real curves depend on composition, heat treatment, test temperature, strain rate and specimen form (wire, tube and so on).
Fig. 3 Conceptual diagram (vector drawing). The shapes of the stress-strain curves for superelasticity (left) and the shape memory effect (right). They are not measured curves, and no axis values are shown.

The strain that can be recovered depends strongly on conditions. The review by Wang et al. cites recovery from deformations of up to about 10% in Ni-Ti [Ref. 10]. Tanaka et al. describe a superelastic strain of more than 13% in an iron-based alloy as “almost twice the maximum superelastic strain obtained in the Ni-Ti alloys” [Ref. 13]. A review of actuators, on the other hand, says that straight wires give predictable cyclic durability at moderate strain levels of 3–4% or less [Ref. 23]. Even the same “recovery strain” means different things for a single recovery or repeated recovery, and with or without load Sourced.

A materials engineer’s view 1: do not read superelasticity from Af alone

Superelasticity is taught as a property above Af. Shamimi et al. argue, however, that in the conditions used for real superelastic parts (cold-worked and aged Ni-Ti), martensite usually reverts not directly to austenite but to the R-phase, and that what sets the unloading plateau is the reverse transformation of martensite, so that Af is irrelevant to the superelastic properties. They show conditions with an Af well above 37 °C (above 45 °C) that still give satisfactory superelasticity at 37 °C Sourced [Ref. 6].

The FDA guidance, too, recommends that when superelasticity is used, either Af (or the R-phase finish temperature R′f where an R-phase is present) or mechanical test data at the temperature of use be provided [Ref. 1]. The practical reading for a materials engineer is to read a transformation temperature together with mechanical tests at the temperature of use (our commentary).

3. What moves the transformation temperatures — composition, processing, aging, cycling, measurement

The transformation temperature is not a constant of an alloy. Fig. 4 shows six factors that the sources confirm.

Six factors that move the transformation temperatures (as far as the sources confirm) The source for each factor is named in the box. Direction and size depend on the alloy system and conditions. 1 Composition (Ni content) In SMAs generally, a 1 at.% change can move the transformation temperature by about 100 K (Beke). NiTi-20Zr: Ni +/-0.2 at.% gives very different values (Carl) 2 Cold work and aging Cold work plus aging (commonly 350-575 C) sets shape, strengthens and tunes the temperatures. The three aims conflict (Shamimi) 3 Low-temperature aging Aging at 100-250 C still causes Ni clustering and Ni4Ti3 precipitation and changes the temperatures (Ni 50.8 at.%, Shamimi) 4 Alloying additions Pt, Pd, Hf, Zr and Au raise the temperatures. Binary NiTi reaches an Af of about 115 C at most (Carl, intro) 5 Repeated thermal cycling Ni-rich NiTi-20Zr lost about 39.5 C of Af over 10 cycles and needed 8 cycles to stabilize (Carl) 6 How it is measured Thermal analysis (F2004) and bend and free recovery (F2082) need not give the same Af (FDA guidance) Transformation temperatures As, Af, Ms, Mf Not “the material’s number” but a number from how it was made and measured * The arrangement is ours. We could not confirm a per-at.% sensitivity of NiTi specifically within the scope of our research. * The 100 K in box 1 is Beke et al.’s statement about shape memory alloys in general, not a value for NiTi alone.
Fig. 4 Conceptual diagram (vector drawing). Our own arrangement of six factors that move the transformation temperatures, as far as the sources confirm [Ref. 8, 6, 9, 1]. Direction and size depend on the alloy system and conditions.

(1) Composition: a small difference in Ni content makes a large difference

In their introduction, Beke and Azim state the known fact that in shape memory alloys a composition change of 1 at.% can shift the transformation temperature by about 100 K. They also note that in Ti–Pd-based alloys this slope varies by about a factor of four, between −15 K/at.% and −60 K/at.%, depending on the third alloying element Sourced [Ref. 8]. This is a statement about shape memory alloys in general, not a value for NiTi alone. In a NiTi-20 at.% Zr high-temperature shape memory alloy, varying Ni by just ±0.2 at.% (49.8, 50.0 and 50.2 at.%) gave very different transformation temperatures, and different responses to aging at 550 °C and 600 °C. In the solutionized state the Ni-lean alloy had the highest transformation temperatures; with aging, those of the Ni-lean alloy kept falling while those of the Ni-rich alloy rose Sourced [Ref. 9].

Our calculation: convert at.% to wt.% and apply a sensitivity

Taking atomic masses of 58.69 for Ni and 47.87 for Ti, we convert the atomic percentage of Ni to a mass percentage Our calculation. Ni 50.0 at.% = 55.08 wt.%, 50.8 at.% = 55.87 wt.% and 51.0 at.% = 56.07 wt.%. In this composition range, 1 at.% is about 1 wt.%.

If a sensitivity of about 100 K per at.% also applied in this range, an error of ±0.05 at.% in the composition analysis would correspond to ±5 K of transformation temperature, and ±0.2 at.% to ±20 K.

Assumptions and limits: about 100 K per at.% is a statement about shape memory alloys in general (the introduction of Beke et al.), not a value for NiTi. We could not show, from the primary sources we confirmed, how much the transformation temperature of NiTi changes per at.% of Ni. The calculation only illustrates the direction: the accuracy of the composition analysis sets the accuracy of the transformation temperature.

(2) Cold work and aging: setting the shape, strengthening, and tuning the temperature

According to Shamimi et al., the medical device industry uses a combination of cold work and aging on Ni-rich Ni–Ti to shape-set, strengthen and adjust the transformation temperatures. These three aims conflict. Accurate shape setting is promoted by longer times at higher temperatures, whereas maximum strength requires keeping the cold work, hence low temperatures and short times. Controlling the transformation temperatures requires precise control of the heat-treatment temperature, which sets the amount of Ni4Ti3 precipitation and the Ni/Ti ratio of the matrix. The commonly used aging and shape-setting range is 350–575 °C Sourced [Ref. 6].

The effect of heat treatment is also shown in a separate study of a similar composition. When a rapidly solidified Ti49Ni51 alloy was heat-treated at 723, 773 and 823 K, the microstructure (B2 phase, Ti3Ni4, Ti2Ni and so on) and the transformation path (such as the number of stages A→R→M) changed, and at 773 K the thermal hysteresis became small Sourced [Ref. 11]. A NASA report found that for nitinol ribbon the room-temperature tensile behavior depends strongly on the thermomechanical history before the test, and that the amount and stress state (twinned or detwinned) of the R-phase decide the critical stress of the first plateau Sourced [Ref. 18].

Even low-temperature aging changes the values. Shamimi et al. aged Ni 50.8 at.% Ni–Ti, after solution treatment and after ordinary cold work plus aging, at a further 25–250 °C for 1 hour to 1 month (720 hours). Even at 100 °C they saw nickel clustering and nanometre-scale Ni4Ti3 precipitation, and the transformation temperatures moved (in a solution-treated sample aged at 100 °C for 105 hours, precipitates of about 5 nm were seen by transmission electron microscopy). The paper points out that many medical devices specify transformation temperature ranges as tight as ±3 °C, and that temperatures in this range occur in processing steps such as co-extrusion and the application and curing of coatings Sourced [Ref. 6].

(3) Repeated thermal cycling: values move until they settle

For their NiTi-20Zr alloys, Carl et al. followed Af and Ms over ten thermal cycles and defined a transformation as “stable” when it dropped by less than 0.5 °C between consecutive cycles. The Ni-lean and equiatomic alloys were nearly stable after three heating cycles in the solutionized state, but the Ni-rich alloy needed eight, and the difference in Af between the first and tenth cycles was 39.5 °C in the solutionized state and about 25 °C after heat treatment Sourced [Ref. 9]. A value measured on the first cycle differs from the value after the alloy has settled in use.

(4) How it is measured: the same sample gives different values by method

The FDA guidance recommends giving the transformation temperatures for the final finished form (after all manufacturing steps, including sterilization), and where possible from samples of at least three production lots, because the transformation temperatures are sensitive to small variations in temperature or heating time. As methods it names thermal analysis (ASTM F2004), bend and free recovery (ASTM F2082) or an equivalent method, and notes that these test methods do not necessarily measure the same Af temperature for a given material or device Sourced [Ref. 1].

NASA researchers tested 55NiTi on specimens from the same heat and the same batch, changing only the test procedure. Under constant stress and thermal cycling, the test procedure changed the transformation strain by 0.005–0.01 mm/mm, which translates to a difference in work output of about 2 J/cm3. The transformation temperatures were less affected than the transformation and irreversible strains, and differed only with respect to the applied external stress. The authors also state that, although shape memory alloys have been around for almost five decades, apart from some standards for transformation temperatures no real standards exist for the mechanical and thermomechanical properties (a statement from 2008) Sourced [Ref. 17].

Our calculation: what stress does a 2 J/cm³ difference correspond to?

Writing the work W as stress σ times strain ε Our calculation, σ = W/ε. Since 1 J/cm3 = 1 MPa, W = 2 J/cm3 = 2 MPa, and dividing by the difference in transformation strain, ε = 0.005 and 0.01, gives about 400 MPa and about 200 MPa. The test can thus be taken to have been run at a stress of roughly 200–400 MPa.

Assumptions and limits: this is a simple estimate with work = stress × strain at constant stress, and we have not checked the stress values in the paper. It gives the scale: a change of 0.005–0.01 in transformation strain from the test method alone changes the work by about 2 J/cm3.

A materials engineer’s view 2: the transformation temperature is a function of composition and of history

The sources so far say the same thing from different angles. The transformation temperature is a function of the final composition (the Ni/Ti ratio and additions), the processing history (the amount of cold work), the thermal history (aging temperature and time, down to low-temperature aging), the service history (thermal cycling) and how it is measured. When Ni4Ti3 precipitates, the matrix loses Ni and Ms rises: the straightforward direction. At low temperature, however, the pre-precipitation stage (nickel clustering) and the pinning of interfaces instead suppress the transformation, an effect in the opposite direction [Ref. 6]. Because the direction reverses with conditions, no one-directional rule of thumb can predict it (our commentary).

In practice, the composition control that fixes the transformation temperature of the raw material and the history of heat and surface treatments after a part is made must be managed separately, and the temperatures measured again on the final form (consistent with the approach of the FDA guidance) [Ref. 1].

4. How superelastic stress changes with temperature

Superelastic stress is tightly linked to temperature. Shamimi et al. express the height of the plateau (the stress at which the transformation starts) as the difference between the test temperature T and Ms, multiplied by the slope of stress against temperature (the Clausius–Clapeyron coefficient) dσ/dT.

σ = ( T − Ms ) × dσ/dT

In systems without an R-phase, dσ/dT is about 6–7 MPa/°C, a value for wire or tube measured in tension (the paper notes that it depends on the deformation mode and the texture). When an R-phase is involved and the A/R/M triple point lies above room temperature, it is the 3.5–4.0 MPa/°C of R→M Sourced [Ref. 6]. For the iron-based Fe–Mn–Al–Ni alloys, Omori et al. report a superelastic stress that varies by only 0.53 MPa/°C (from −196 to 240 °C) for one composition, which they explain by a small transformation entropy change brought about by a magnetic contribution Sourced [Ref. 12].

Our calculation: how shifts in temperature or transformation temperature turn into shifts in stress

Using dσ/dT = 6.5 MPa/°C (the middle of 6–7) Our calculation, at a use temperature of 37 °C and Ms = 0 °C the plateau is (37 − 0) × 6.5 = about 240 MPa, and with Ms = −10 °C about 305 MPa. A 10 °C difference in Ms changes the plateau stress by about 60–70 MPa. If the tolerance on the transformation temperature is ±3 °C, the scatter in plateau stress is ±18–21 MPa.

For the same ±3 °C, Fe–Mn–Al–Ni (0.53 MPa/°C) gives only about ±1.6 MPa. For a 100 °C rise above the reference temperature, the stress increases by about 600–700 MPa for NiTi (A→M), about 350–400 MPa for NiTi (R→M) and about 53 MPa for Fe–Mn–Al–Ni (Fig. 5).

Assumptions and limits: this extrapolates the slopes as constants over the whole range. For NiTi, as temperature rises the stress reaches the limit of yielding (slip), so the lines for 100 °C do not exist in practice. Omori et al. point out that the rise of superelastic stress with temperature limits practical use over a wide temperature range [Ref. 12]. The calculation is for comparing slopes.

How far the superelastic stress rises as temperature rises (our calculation) Slopes (MPa/C) are from the sources; lines are drawn by us from the origin. ΔT is the rise from a reference temperature. 0 20 40 60 80 100 0 200 400 600 ΔT: rise above the reference temperature (C) Δσ (MPa) NiTi (A to M): 6-7 MPa/C NiTi (R to M): 3.5-4.0 MPa/C Fe-Mn-Al-Ni: 0.53 MPa/C ΔT = 10 C: NiTi (A to M) rises by about 60-70 MPa * NiTi: Shamimi et al. (tension of wire and tube; depends on deformation mode and texture). Fe-Mn-Al-Ni: Omori et al. (one alloy, -196 to 240 C). * In practice the stress reaches the slip limit as temperature rises, so extending the lines is not valid. The figure compares slopes. * With the R-phase involved, the slope (R to M) is smaller than for A to M (Shamimi et al.).
Fig. 5 Chart including our calculation (vector drawing). How fast superelastic stress rises with temperature, drawn from the slopes of Shamimi et al. [Ref. 6] and Omori et al. [Ref. 12]. The extended lines do not exist in practice; the purpose is to compare slopes.

The shape of the superelastic plateau also needs care. Shamimi et al. say that strain localization such as the “Lüders bands” seen in uniaxial tension (the transformation spreading in bands) shows up as a drop in stress on unloading (a reverse yield drop) and a flat plateau, and that the unloading plateau can be higher than predicted from the transformation temperatures of a stress-free thermal test [Ref. 6]. The transformation temperature from thermal analysis and the plateau stress from tensile tests must be measured separately and then related to each other.

5. Fatigue — read it with strain amplitude and number of cycles

Fatigue of shape memory alloys has two meanings. “Structural fatigue” is failure by cracks that start and grow under repeated loading. “Functional fatigue” is the gradual change, before failure, of functions such as the transformation temperatures, the plateau stress and the residual strain. The title of the review by Eggeler et al., “Structural and functional fatigue of NiTi shape memory alloys”, reflects this distinction [Ref. 26]. The fall in Af during thermal cycling in Carl et al. (Section 3) is an example of a change in function [Ref. 9].

On structural fatigue, an FDA regulatory science tool explains that several studies have associated low-cycle fatigue (less than approximately 10 million cycles) with cyclic phase transformation in nitinol, that load levels without cyclic phase transformation would be expected to survive to approximately 10 million cycles, and that fatigue fractures beyond 10 million cycles may still occur. It applies only to pseudoelastic nitinol Sourced [Ref. 2]. The FDA guidance recommends fatigue testing in a liquid close to the service environment rather than in air, because tests in air are sensitive to test frequency through heating effects. It says that a constant-life diagram of mean versus alternating strain, rather than stress, has been found to model fatigue life well, that fatigue life is sensitive to composition and processing, and that the effect of pre-strain (such as crimping a stent) should be considered Sourced [Ref. 1].

A recent study shows a large extension of bending-fatigue life by surface treatment. With a surface treatment called pre-strain warm laser shock peening (a method that works the surface layer by the impact of laser pulses), the bending fatigue life exceeded 5 million cycles at a maximum surface tensile strain of 1.94%, more than 3000 times that of untreated nanocrystalline NiTi (the authors’ claim, for a specific NiTi and specific conditions) Sourced [Ref. 25]. For temperature, Lin et al. found in dynamic mechanical analysis tests that above Af the fatigue life becomes shorter as temperature rises and the energy dissipation decreases [Ref. 24].

Our calculation: how long does a test of 10 million cycles take?

Taking the roughly 10 million cycles (107) given by the FDA regulatory science tool as a guide Our calculation, at 1 Hz the test takes 107 ÷ 86,400 s/day = about 116 days. At 50 Hz it is about 55.6 hours and at 60 Hz about 46 hours.

Assumptions and limits: a simple calculation for a machine that runs continuously. A higher frequency speeds up the test, but as the FDA guidance says, tests in air become sensitive to test frequency because of heating from the transformation, and the result can change [Ref. 1]. The number of cycles must be read together with frequency and environment.

A materials engineer’s view 3: a fatigue number is a package of five items — strain amplitude, mean strain, cycles, environment and surface

A statement such as “it lasts 10 million cycles” means something only when it says at what strain amplitude and mean strain, in what temperature and environment, with what surface and on what specimen (a wire or a part cut from a product). The FDA guidance asks for the constant-life diagram to be built experimentally on samples representative of the final form because fatigue life is sensitive to composition and processing [Ref. 1]. That surface treatment can change life by orders of magnitude [Ref. 25], and that life changes depending on whether the test temperature exceeds Af [Ref. 24], are reasons why fatigue data for a wire cannot be carried over to other shapes or heat treatments (our commentary).

6. Cu-based, Fe-based and high-temperature shape memory alloys

Ni–Ti is at the centre of practical use, but other alloy systems have their own features. Tanaka et al. state that, as of 2010, the Ni-Ti-based alloy, which exhibits some ductility and excellent superelastic strain, was the only superelastic material available for practical applications Sourced [Ref. 13]. The table summarizes what we could confirm, including later systems.

Alloy systemWhat we could confirmWhat we could not confirm
Ni–Ti (nitinol)Nearly equiatomic. B2, B19′ and R-phase. A principal material for medical devices [Ref. 1]. Recovery from deformation of up to about 10% (cited value) and tensile elongation above 30% (cited value) [Ref. 10]Like-for-like performance comparison with other systems
Cu–Al–MnPolycrystals with a low degree of order of the β (L21) phase are ductile and show superelasticity and the one-way and two-way memory effects. Controlling grain size and texture by thermomechanical treatment greatly improves the properties. An application to a medical guidewire is presented [Ref. 15]Numbers for transformation temperature, fatigue and cost
Cu–Zn–AlTanaka et al. state that Ni-Ti and Cu-Zn-Al show reversible strains of more than several percent [Ref. 13]Individual properties and durability
Fe–Mn–Al–NiA polycrystalline ferrous alloy with a superelastic strain above 13% and a tensile strength above 1 GPa (almost twice the maximum superelastic strain of Ni-Ti), and a large damping capacity [Ref. 13]. A small temperature dependence of the superelastic stress (0.53 MPa/°C, one example from −196 to 240 °C) [Ref. 12]Fatigue life, components of practical size, cost
High-temperature shape memory alloys (Ni–Ti–Pd, Ni–Ti–Pt, Ni–Ti–Hf, Ni–Ti–Zr and others)Three groups by Ms: I = 100–400 °C, II = 400–700 °C, III = above 700 °C. The criteria are recoverable strain, long-term stability, resistance to plastic deformation and creep, and environmental resistance; poor workability and material cost are the problems. Applications have been demonstrated in Ti–Ni–Pd and Ti–Ni–Pt [Ref. 14]. The Af of binary Ni-Ti is about 115 °C at most and rises with Au, Pt, Pd, Hf or Zr (the authors state that, apart from Hf and Zr, these additions raise cost greatly) [Ref. 9]Mass production; long-term thermal-cycling stability of each system (beyond the results of Carl et al.)

All Sourced (statements in the abstracts and introductions of the papers). The arrangement of the table is our commentary. Values for different systems come from different test conditions and sample forms, so they are not ranked against each other.

Transformation temperatures from binary NiTi to high-temperature SMAs A bar ending in an arrow means “at or above”. The indicator (Af, Ms, transformation temperatures) differs between sources. 0 100 200 300 400 500 600 700 800 900 Temperature (C) Binary NiTi, Af about 115 C at most Group I (Ms) 100-400 C Group II (Ms) 400-700 C Group III (Ms) 700 C and above Ni30Pt20Ti50 transformation temps above 230 C Ni20Pt30Ti50 transformation temps above 530 C * Groups: Ma et al. (ranges of Ms). About 115 C: introduction of Carl et al. (Af of binary NiTi). Pt alloys: Noebe et al. * A high transformation temperature does not mean a high work output. Ni20Pt30Ti50 gave zero work under load (Section 6).
Fig. 6 Conceptual diagram (vector drawing). A guide to the transformation temperatures of high-temperature SMAs, from the values of Ma et al. [Ref. 14], Carl et al. [Ref. 9] and Noebe et al. [Ref. 16]. The indicator (Af, Ms, transformation temperatures) differs between sources.

The NASA report by Noebe et al. shows that “having a high transformation temperature” and “being able to do work” are different things. Ni30Pt20Ti50 (20Pt) has transformation temperatures above 230 °C and Ni20Pt30Ti50 (30Pt) above 530 °C. Both, deformed at room temperature, showed 100% no-load strain recovery for strain levels up to their fracture limit (3–4%). Under constant load and thermal cycling, however, the 20Pt alloy behaved like conventional binary NiTi, with a maximum work output of nearly 9 J/cm3 limited by its tensile ductility. The 30Pt alloy, in contrast, had an austenite yield strength similar to or lower than that of martensite, so its transformation strain under load was essentially zero and its work output was zero Sourced [Ref. 16].

A materials engineer’s view 4: going to high temperature is a matter of strength reversal and stability, not only of temperature

The problem with high-temperature shape memory alloys is not only raising the transformation temperature. In the 30Pt alloy of Noebe et al., if the high-temperature phase is not stronger than the low-temperature phase, the alloy cannot do work against a load [Ref. 16]. Ma et al. organize the criteria as recoverable strain, long-term stability, resistance to plastic deformation and creep, and environmental resistance, which become harder to satisfy at higher operating temperatures (more thermally activated mechanisms are involved) [Ref. 14]. In the Ni-rich NiTi-20Zr of Carl et al., Af fell by about 40 °C over ten thermal cycles [Ref. 9]. The height of the transformation temperature, the stability under repeated cycling and the order of strengths must be checked separately (our commentary).

7. Applications and how they are evaluated — medical devices, aerospace, actuators

(1) Medical devices: what regulatory documents ask of the material

The FDA guidance says that nitinol is used in cardiovascular devices such as stents, heart valves, guidewires and vena cava filters, and in a growing number of products for minimally invasive procedures. It adds that nitinol’s thermomechanical behavior and processing sensitivity raise special considerations compared with conventional metals such as stainless steel, titanium or cobalt-chrome, and it sets out technical considerations for non-clinical assessment. The guidance contains nonbinding recommendations; the version issued on 9 July 2021 is the current one Sourced [Ref. 1].

From the materials side, the guidance’s items correspond to the earlier sections of this article (our commentary).

Item in the guidance (Section IV)What is requested (summary)Section of this article
A-1 Material compositionState conformity to a recognized consensus standard (for example ASTM F2063); if the nitinol does not conform, give its composition and propertiesSection 3 (1)
A-2 ManufacturingA flow of processes from raw material to final form, with detail on thermal processes (laser cutting, annealing, shape setting) and surface processingSection 3 (2)
A-3 Pseudoelasticity / shape memoryState which behavior is used, or that neither isSection 2
A-4 Transformation temperaturesOn the final finished form, from three or more lots where possible. For pseudoelasticity, Af (or R′f) or mechanical data at the temperature of use; for shape memory, also As, Ms and Mf. F2004, F2082 or an equivalent methodSection 3 (4)
B Mechanical testingDisplacement control, preconditioning, testing at the relevant temperature, fatigue in a liquid, a constant-life diagram, pre-strain. Material-model parameters from F2516 and similarSections 4 and 5
C Corrosion testingPitting corrosion (following the F2129 procedure), nickel ion release and galvanic corrosion; dependent on the surface finishSection 9 (standards)
D, E Biocompatibility and labelingEvaluation of biocompatibility and warning labelingNot covered here

All Sourced (a summary of the items of the FDA guidance [Ref. 1]). The guidance ties the details of each item to the conditions of each product. This article does not assess any particular product and gives no medical advice.

(2) Aerospace: actuation, weight saving and high temperature

The review by Hartl and Lagoudas covers aerospace applications of shape memory alloys, for both atmospheric flight and space flight, including past and present examples and design challenges [Ref. 22]. NASA technical reports give concrete examples.

  • Variable geometry chevron: chevrons, the serrated trailing edges of a jet engine’s exhaust nozzle, reduce noise at takeoff. Cabell et al. tested a full-scale variable geometry chevron (VGC) fan nozzle incorporating shape memory alloy actuators under representative flow conditions in Boeing’s Nozzle Test Facility. A proportional-integral control system that regulates the heating of the actuators controlled the chevron’s tip immersion, and controllable immersion was demonstrated Sourced [Ref. 19].
  • For hot exhaust: a 2011 NASA Tech Brief explains that high-temperature shape memory alloy technology enables adaptive chevron devices to operate in both the low-temperature fan flow and the high-temperature core flow Sourced [Ref. 20].
  • Superelastic spring tire: NASA Glenn Research Center and Goodyear developed a compliant, non-pneumatic tire made of woven coil springs for Martian and Lunar rover vehicles. The version with superelastic shape memory alloy springs is described as able to undergo approximately 30 times more reversible deformation than a steel spring, and large-scale finite element analysis that includes the complex interaction of the springs is used in its design Sourced [Ref. 21].
Load and temperature are controlled during superelasticity testing
Fig. 7 Conceptual image generated with ImageGen. Load and temperature are controlled during superelasticity testing. Stress-driven transformation is distinguished from thermally triggered shape recovery. Not actual facilities, products or measured results.

(3) Actuators: response is set by cooling more than by heating

A 2026 review by Romančík et al. says that shape memory alloy actuators are most commonly cooled by heat dissipation to the room-temperature surroundings, and that faster operation needs forced cooling such as forced air convection, heat sinks, cooling liquids or Peltier elements. The response time is governed by the heating and, in particular, the cooling rate, and one motion cycle usually takes several seconds; this is among the most significant limitations. Straight wires give high recovery stress and predictable cyclic durability at moderate strain (3–4% or less), but their usable stroke is limited. Coils amplify displacement at the expense of mechanical bandwidth and fatigue life, and multi-wire bundles accumulate heat, which reduces the achievable cycle frequency Sourced [Ref. 23]. The same review states that the energy density of SMA actuators is reported at 5000–25,000 kJ/m3, far above the 40–70 kJ/m3 of human skeletal muscle Sourced [Ref. 23].

Our calculation: checking the order of magnitude of work as stress times strain

An upper estimate of work is stress times strain Our calculation. For 200 MPa and 4% strain (illustrative values), 200 MPa × 0.04 = 8 MPa = 8 J/cm3 (= 8000 kJ/m3). This lies within the 5000–25,000 kJ/m3 reported by the review above and is of the same order as the maximum work output of the 20Pt alloy of Noebe et al. (about 9 J/cm3 = 9000 kJ/m3) [Ref. 16]. Against skeletal muscle’s 40–70 kJ/m3 the ratio is 8000 ÷ 70 = about 114 to 8000 ÷ 40 = 200 times.

Assumptions and limits: an idealization in which the stress is constant over the whole strain. The value is per volume of alloy, not for a complete actuator including the heating and cooling hardware, the bias spring and the wiring. In the NASA test of Section 3, the test method alone moved the work by about 2 J/cm3, roughly a quarter of this example [Ref. 17]. Output figures must be read with matched conditions.

(4) Fabrication and processing

Wang et al. say that NiTi has poor workability, which makes complex-shaped components difficult, and that additive manufacturing such as selective laser melting (SLM) offers freedom to build complex structures. Their review summarizes the distinctive microstructure that SLM produces and the transformation behavior and mechanical properties reported for various build conditions Sourced [Ref. 10]. The transformation temperatures and function of built parts are likely to depend on build conditions and heat treatment (our commentary), but a quantitative comparison is outside the scope of our research.

8. Limits, and what we could not confirm

(1) The quantitative link between composition and transformation temperature

We could not show, from the primary sources we confirmed, how much the transformation temperature of NiTi changes per at.% of Ni. The “about 100 K per at.%” in Section 3 is a statement about shape memory alloys in general.

(2) How the papers were read

We read the full texts of Shamimi et al., the FDA guidance, the FDA regulatory science tool page, the introduction and results of Carl et al., the introduction of Beke et al. and the introduction of Wang et al. For Tanaka et al., Omori et al., Ma et al. and Sutou et al. we checked the publisher abstracts only, and for the NASA reports the abstracts on the NASA Technical Reports Server only. For the reviews of Eggeler et al. and of Otsuka and Ren, we confirmed only existence and bibliographic details. The Elsevier (ScienceDirect) pages state that AI and similar uses are prohibited, so we did not retrieve their contents.

(3) The text of the standards

We have not read the text of JIS H 7001 to 7107 or of ASTM F2004, F2063, F2082, F2516, F2005, F2633, F3211, E2948 and F2129. We confirmed only numbers, titles, years, FDA recognition status and the dates of establishment and revision of the JIS. The ASTM International website states that AI use is prohibited, so we did not open any ASTM site.

(4) International standards (ISO, IEC, IEEE)

A search of the ISO catalogue (10 October 2026) found no standards for “shape memory alloy” or “nitinol”. We could not confirm any applicable IEC or IEEE standard either. Application-specific standards, such as those for orthodontic wires, may cover NiTi, but we did not check this.

(5) Regulation and markets

The FDA guidance is a US document. We have not checked how Japanese or EU medical device regulation treats nitinol, nor prices and supply in any country. We do not rank any company’s products.

(6) Differences between sources

The role of Af differs between sources (Shamimi et al. argue that it can be an unsuitable indicator of superelasticity, whereas the FDA asks for Af, R′f or mechanical data). This article shows both and does not unify them.

9. How to read the evaluation standards

The evaluation of shape memory alloys divides into (a) transformation temperatures (As, Af, Ms, Mf and the R-phase temperatures), (b) tensile properties (plateau stress, recovery strain, residual strain), (c) behavior under repetition (changes of transformation temperature in thermal cycling, mechanical fatigue), (d) composition and specification, and (e) corrosion and release. Japan has a dedicated group of JIS H 7xxx standards for shape memory alloys, and the US has the ASTM F series (a group of nitinol standards for medical devices and surgical implants). We could not confirm international standards (ISO, IEC, IEEE) within the scope of our research.

Table of corresponding standards

JIS titles are our translations from the Japanese.

Evaluation itemISOIEC / IEEEJISASTMWhat changes the value with the test conditions
Transformation temperatures (thermal analysis; bend and free recovery) SourcedCould not be confirmedCould not be confirmedJIS H 7101 (method for determining the transformation temperature of shape memory alloys; established 1 March 1989, latest revision 20 March 2002, confirmed 20 October 2021)F2004 “Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis” (-24); F2082/F2082M “Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery” (-23)Thermal analysis and bend and free recovery need not give the same Af (FDA). Final form or raw material, number of lots, composition and heat treatment all change the value
Tensile properties (superelastic and shape memory) SourcedISO 6892-1:2019 (room-temperature tensile testing of metals in general; not specific to superelastic alloys)Could not be confirmedJIS H 7103 (tensile test method for Ti-Ni shape memory alloys; established 1 September 1991, revised 22 October 2012, confirmed 20 October 2022); JIS Z 2241 (metallic materials in general)F2516 “Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials” (-22)Test temperature (the plateau rises with temperature), strain rate, specimen form (wire, tube) and pre-treatment
Constant-strain and thermal-cycle tests of coil springs (actuators) SourcedCould not be confirmedCould not be confirmedJIS H 7105 (constant-strain test method for Ti-Ni shape memory alloy coil springs; revised 22 October 2012, confirmed 20 October 2022); JIS H 7106 (constant-strain thermal-cycle test method for shape memory alloy coil springs; revised 20 March 2002, confirmed 20 October 2021)Could not be confirmedSize of the strain, number of cycles, heating and cooling conditions
Material specification (composition, properties, form) SourcedCould not be confirmedCould not be confirmedJIS H 7107 (Ti-Ni shape memory alloy wire, strip and tube; established 20 October 2003, revised 20 April 2009, confirmed 21 October 2024)F2063 “Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants” (-18); F2633 “Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants” (-19)Conforming to the specification does not remove the need to check transformation temperature and fatigue on the final form (the approach of the FDA guidance)
Terminology SourcedCould not be confirmedCould not be confirmedJIS H 7001 (shape memory alloy terminology; established 1 March 1989, revised 20 April 2009, confirmed 21 October 2024)F2005 “Standard Terminology for Nickel-Titanium Shape Memory Alloys” (-21)As, Af, Ms and Mf are defined to include the R-phase in two-stage transformations
Fatigue SourcedCould not be confirmedCould not be confirmedCould not be confirmedF3211 “Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices” (-17); E2948 “Standard Test Method for Conducting Rotating Bending Fatigue Tests of Solid Round Fine Wire” (-24); F2477 “Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses” (-23, -24)Strain amplitude and mean strain, frequency, liquid or air, pre-strain and surface (FDA guidance and regulatory science tool)
Corrosion and nickel release SourcedISO 10993-15:2019 “Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys” (2nd edition)Could not be confirmedCould not be confirmedF2129 “Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices” (-24)Surface finish (electropolishing, chemical etching and so on), geometry and environment (FDA guidance)

Numbers, titles and editions were confirmed as follows: ISO on the ISO catalogue pages; JIS in the JISC database; ASTM in the FDA database of recognized consensus standards (last updated 28 September 2026); we did not open any ASTM site [Ref. 29, 28, 32, 33, 3, 4, 5]. The arrangement of the table is our commentary. The ASTM editions (-24, -23, -18 and so on) are those listed in the FDA database and are not necessarily the latest.

The number, title, edition and date of each standard are Sourced (confirmed on the official pages of the standards bodies, the Japanese Industrial Standards Committee and the FDA). Which standard goes in which cell is our own arrangement (Our calculation). We found no revision or draft in progress, so no row falls under Not yet confirmed.

Cautions when reading standards

  1. Many of the JIS standards for shape memory alloys were last revised long ago. H 7101 and H 7106 were revised in 2002, H 7001 and H 7107 in 2009, and H 7103 and H 7105 in 2012, and all have been confirmed in recent years (2021 to 2024) [Ref. 33, 32]. The ASTM F series, on the other hand, has had its editions updated in recent years for medical devices (FDA recognition status) [Ref. 3]. JIS and ASTM assume different objects of measurement (laboratory evaluation of a raw material versus a component of a medical device), so their numbers cannot be compared directly.
  2. Standards for transformation temperature can give different values depending on the method. The FDA notes that F2004 and F2082 need not give the same Af [Ref. 1]. Read a reported value together with the method, the state of the sample (raw material or final form) and the heating rate.
  3. We found no standard that directly specifies fatigue of superelastic alloys. Fatigue is planned by combining F3211 (a guide to fatigue-to-fracture methodology for cardiovascular devices), E2948 (rotating-bending fatigue of fine wire) and others, following the approach of the FDA regulatory science tool [Ref. 2, 5, 4]. A standard is a method, not a guarantee of life.
  4. NASA researchers stated in 2008 that standards for the mechanical and thermomechanical properties were not in place. That F2516 and others have since been put in place can be seen from FDA recognition [Ref. 3], but we could not confirm an international standard that directly specifies actuator use (thermal cycling under load, work output) [Ref. 17].
Summary
  • A shape memory alloy undergoes a reversible transformation between two crystal structures, driven by temperature or by stress. The temperatures are Ms, Mf, As and Af, and an R-phase may intervene Sourced
  • The transformation temperatures move with composition, processing, aging (even at low temperature), thermal cycling and measurement. In NiTi-20Zr, Ni ±0.2 at.% made a large difference, and in the Ni-rich alloy Af moved by about 40 °C over ten thermal cycles Sourced
  • Superelastic stress rises in proportion to temperature. About 6–7 MPa/°C for NiTi, 3.5–4.0 when an R-phase is involved and 0.53 MPa/°C for Fe–Mn–Al–Ni Sourced. A 10 °C difference in Ms corresponds to about 60–70 MPa of plateau stress Our calculation
  • Read fatigue with strain amplitude, mean strain, cycles, environment and surface. Low-cycle fatigue below about 10 million cycles is associated with cyclic phase transformation Sourced
  • For high-temperature shape memory alloys, a high transformation temperature is not the same as the ability to do work. Ni20Pt30Ti50 gave zero work output under load Sourced
  • The evaluation standards are mainly JIS H 7xxx and the ASTM F series; we could not confirm dedicated ISO, IEC or IEEE standards.

10. Glossary

Shape memory effect
The recovery of the original shape on heating after deformation at low temperature.
Superelasticity (pseudoelasticity)
Above Af, a large deformation caused by a stress-induced transformation that recovers on unloading.
Austenite / martensite
The high-temperature phase (B2 structure in Ni-Ti) and the low-temperature phase (B19′ structure, monoclinic).
R-phase
An intermediate (rhombohedral) phase that can appear between austenite and martensite.
Ms, Mf, As, Af
The start and finish temperatures of the transformation on cooling, and of the reverse transformation on heating.
Plateau
The range over which stress is nearly constant while the transformation proceeds.
Clausius–Clapeyron coefficient
The rate at which the transformation stress rises with temperature (dσ/dT).
Ni4Ti3
A phase that precipitates on aging Ni-rich Ni-Ti and changes the Ni content of the matrix.
Aging
A heat treatment, after solution treatment or cold work, that holds the alloy at a moderate temperature to cause precipitation and similar changes.
Structural / functional fatigue
Failure by cracks / changes of function such as transformation temperature and stress.
HTSMA
High-temperature shape memory alloy: one whose transformation temperatures exceed 100 °C.
DSC
Differential scanning calorimetry; one way of finding transformation temperatures by measuring heat absorbed or released as temperature is varied.

11. References (primary sources)

  1. U.S. Food and Drug Administration (FDA) “Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol — Guidance for Industry and FDA Staff” (issued 9 July 2021; first issued 15 October 2020; draft 19 April 2019; docket FDA-2019-D-1261; states that it contains nonbinding recommendations) — www.fda.gov/regulatory-information/search-fda-guidance-documents/te…
  2. U.S. FDA, Center for Devices and Radiological Health (CDRH) “Strategy to Estimate Low to High Cycle Fatigue Transition of Nitinol for Fatigue to Fracture Test Planning” (Catalog of Regulatory Science Tools) — cdrh-rst.fda.gov/strategy-estimate-low-high-cycle-fatigue-transitio…
  3. U.S. Food and Drug Administration (FDA) “Recognized Consensus Standards: Medical Devices” database, search results for titles containing nickel-titanium (database page last updated 28 September 2026) — www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?…
  4. U.S. Food and Drug Administration (FDA) “Recognized Consensus Standards: Medical Devices” database, search results for titles containing nitinol (page last updated 28 September 2026) — www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?…
  5. U.S. Food and Drug Administration (FDA) “Recognized Consensus Standards: Medical Devices” database, search results for reference number F3211 — www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?…
  6. Shamimi A. et al. “The Effect of Low Temperature Aging and the Evolution of R-Phase in Ni-Rich NiTi”, Shap. Mem. Superelasticity 4, 417–427 (2018), DOI 10.1007/s40830-018-0193-9 (full text hosted on a Confluent Medical Technologies page) — doi.org/10.1007/s40830-018-0193-9
  7. Confluent Medical Technologies Full-text PDF of the paper by Shamimi et al. above (company document page; we read this full text) — confluentmedical.com/wp-content/uploads/2023/05/5851cb2c40d9a5258e0…
  8. Beke D. L., Azim A. A. “On the Strong Composition Dependence of the Martensitic Transformation Temperature and Heat in Shape Memory Alloys”, Materials 17, 4116 (2024), DOI 10.3390/ma17164116 (open access) — doi.org/10.3390/ma17164116
  9. Carl M. et al. “Effect of Ni-Content on the Transformation Temperatures in NiTi-20 at. % Zr High Temperature Shape Memory Alloys”, Metals 7, 511 (2017), DOI 10.3390/met7110511 (open access) — doi.org/10.3390/met7110511
  10. Wang X. et al. “A Short Review on the Microstructure, Transformation Behavior and Functional Properties of NiTi Shape Memory Alloys Fabricated by Selective Laser Melting”, Materials 11, 1683 (2018), DOI 10.3390/ma11091683 (open access) — doi.org/10.3390/ma11091683
  11. Li S. et al. “Effect of Heat Treatment Temperature on Martensitic Transformation and Superelasticity of the Ti49Ni51 Shape Memory Alloy”, Materials 12, 2539 (2019), DOI 10.3390/ma12162539 (open access) — doi.org/10.3390/ma12162539
  12. Omori T. et al. “Superelastic Effect in Polycrystalline Ferrous Alloys”, Science 333, 68–71 (2011), DOI 10.1126/science.1202232 — doi.org/10.1126/science.1202232
  13. Tanaka Y. et al. “Ferrous Polycrystalline Shape-Memory Alloy Showing Huge Superelasticity”, Science 327, 1488–1490 (2010), DOI 10.1126/science.1183169 — doi.org/10.1126/science.1183169
  14. Ma J., Karaman I., Noebe R. D. “High temperature shape memory alloys”, Int. Mater. Rev. 55, 257–315 (2010), DOI 10.1179/095066010X12646898728363 — doi.org/10.1179/095066010X12646898728363
  15. Sutou Y. et al. “Ductile Cu–Al–Mn based shape memory alloys: General properties and applications”, Mater. Sci. Technol. 24, 896–901 (2008), DOI 10.1179/174328408X302567 — doi.org/10.1179/174328408X302567
  16. Noebe R. et al. (NASA) “Properties and Potential of Two (Ni,Pt)Ti Alloys for Use as High-Temperature Actuator Materials”, Proc. SPIE (16 May 2005), NASA Technical Reports Server 20050185200 — ntrs.nasa.gov/citations/20050185200
  17. Padula S. A. II et al. (NASA) “Influence of Test Procedures on the Thermomechanical Properties of a 55NiTi Shape Memory Alloy” (conference paper, March 2008), NASA Technical Reports Server 20080047419 — ntrs.nasa.gov/citations/20080047419
  18. Lach C. L. et al. (NASA) “Effects of Thermomechanical History on the Tensile Behavior of Nitinol Ribbon” (2002), NASA Technical Reports Server 20030014802 — ntrs.nasa.gov/citations/20030014802
  19. Cabell R. H. et al. (NASA) “Feedback Control of a Morphing Chevron for Takeoff and Cruise Noise Reduction” (2004), NASA Technical Reports Server 20040139184 — ntrs.nasa.gov/citations/20040139184
  20. Quackenbush T. R., McKillip R. M. Jr. (NASA) “High-Temperature Smart Structures for Engine Noise Reduction and Performance Enhancement” (NASA Tech Briefs, February 2011), NASA Technical Reports Server 20110012201 — ntrs.nasa.gov/citations/20110012201
  21. Naghipour P. et al. (NASA) “Development of the Shape Memory Alloy Spring Tire for Martian Temperatures” (NASA Technical Reports Server 20260008869, released September 2026) — ntrs.nasa.gov/citations/20260008869
  22. Hartl D. J., Lagoudas D. C. “Aerospace applications of shape memory alloys”, Proc. Inst. Mech. Eng. G 221, 535–552 (2007), DOI 10.1243/09544100JAERO211 — doi.org/10.1243/09544100JAERO211
  23. Romančík J. et al. “Shape Memory Alloy Actuators in Robotics”, Actuators 15, 162 (2026), DOI 10.3390/act15030162 (open access) — doi.org/10.3390/act15030162
  24. Lin Y. et al. “Experimental Study on Temperature Effects on NiTi Shape Memory Alloys under Fatigue Loading”, Materials 13, 573 (2020), DOI 10.3390/ma13030573 (open access) — doi.org/10.3390/ma13030573
  25. Yan et al. “Bending-fatigue-resistant hierarchical NiTi shape memory alloy”, Nat. Commun. 17, 6376 (2026), DOI 10.1038/s41467-026-72857-z (open access) — doi.org/10.1038/s41467-026-72857-z
  26. Eggeler G. et al. “Structural and functional fatigue of NiTi shape memory alloys”, Mater. Sci. Eng. A 378, 24–33 (2004), DOI 10.1016/j.msea.2003.10.327 — doi.org/10.1016/j.msea.2003.10.327
  27. Otsuka K., Ren X. “Physical metallurgy of Ti–Ni-based shape memory alloys”, Prog. Mater. Sci. 50, 511–678 (2005), DOI 10.1016/j.pmatsci.2004.10.001 — doi.org/10.1016/j.pmatsci.2004.10.001
  28. ISO “ISO 10993-15:2019 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys” (ISO catalogue page) — www.iso.org/standard/68937.html
  29. ISO “ISO 6892-1:2019 Metallic materials — Tensile testing — Part 1: Method of test at room temperature” (ISO catalogue page) — www.iso.org/standard/78322.html
  30. Japanese Industrial Standards Committee (JISC) JISC database entry for “JIS Z 2241” (tensile testing method for metallic materials; established 22 July 1952, latest revision 21 August 2023 [Amendment 1]) — www.jisc.go.jp/app/jis/general/GnrJISNumberNameSearchList?show&jisS…
  31. Japanese Standards Association (JSA) Preview pages of JIS Z 2241:2022 (the foreword names ISO 6892-1:2019 as the corresponding international standard, degree of correspondence MOD) — webdesk.jsa.or.jp/preview/pre_jis_z_02241_000_000_2022_j_ed10_ch.pdf
  32. Japanese Industrial Standards Committee (JISC) JISC JIS search, list of JIS numbers starting with H 7 (including the JIS for shape memory alloys) — www.jisc.go.jp/app/jis/general/GnrJISNumberNameSearchList?show&jisS…
  33. Japanese Industrial Standards Committee (JISC) JIS search (by number or title). JIS Z 2255, C 2501, K 7121, K 7122, R 1611, H 7801, R 3257, R 1703-1, H 7101 and others were confirmed (number, title, dates of establishment and revision) on the JIS list and detail pages — www.jisc.go.jp/app/jis/general/GnrJISSearch.html

12. Claim-to-source audit

Claim in the textBasisType
That nitinol is a nearly equiatomic Ni–Ti alloy and that the reversible transformation between austenite and martensite is induced by temperature (shape memory) or stress (pseudoelasticity). The definitions of As, Af, Ms, Mf, the R-phase and R′ (including two-stage transformations). Use in medical devices (stents, heart valves, guidewires, vena cava filters and others). The issue date of the guidance (9 July 2021; first issued 15 October 2020; draft 19 April 2019) and that it contains nonbinding recommendations. Dependence on composition, thermal history, surface processing and preconditioning. Transformation temperatures on the final form, from three or more lots. That F2004 and F2082 need not give the same Af. Displacement control, preconditioning, fatigue testing in liquid, the constant-life diagram, pre-strain, the use of F2516, and the corrosion and nickel-release itemsFull text of the FDA guidance
Reference 1 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-non-clinical-assessment-medical-devices-containing-nitinol
Sourced
The relation between low-cycle fatigue (below about 10 million cycles) and cyclic phase transformation; load levels without phase transformation expected to survive about 10 million cycles; applicability only to pseudoelastic nitinol; use of F3211FDA regulatory science tool
Reference 2 https://cdrh-rst.fda.gov/strategy-estimate-low-high-cycle-fatigue-transition-nitinol-fatigue-fracture-test-planning
Sourced
Low-temperature aging of Ni 50.8 at.% Ni–Ti (25–250 °C, 1–720 hours); about 5 nm Ni4Ti3 precipitates and nickel clustering after 105 hours at 100 °C; the usual temperature range of cold work plus aging (350–575 °C) and the conflict of the three aims; a tolerance of ±3 °C on the transformation temperature; control by Ni4Ti3 and the matrix Ni/Ti ratio; the role of the R-phase and Af (the claim that Af is irrelevant; superelasticity at 37 °C with Af above 45 °C); dσ/dT (6–7, and 3.5–4.0 MPa/°C for R→M); σ = (T − Ms) dσ/dT; Lüders bands and the reverse yield dropFull text of Shamimi et al. (2018)
Reference 6 https://doi.org/10.1007/s40830-018-0193-9
Reference 7 https://confluentmedical.com/wp-content/uploads/2023/05/5851cb2c40d9a5258e08682b2ad73354.pdf
Sourced
That in shape memory alloys in general 1 at.% of composition can shift the transformation temperature by about 100 K. That in Ti–Pd systems the slope varies by about a factor of four, −15 to −60 K/at.%, with the third elementIntroduction of Beke and Azim (2024)
Reference 8 https://doi.org/10.3390/ma17164116
Sourced
Transformation temperatures of NiTi-20 at.% Zr (Ni 49.8, 50.0, 50.2 at.%) and the differing response to aging (550, 600 °C); eight cycles to stabilize for the Ni-rich alloy; the fall of Af of 39.5 °C (solutionized) and about 25 °C (heat-treated); the definition of stability (less than 0.5 °C between consecutive cycles); the Af of binary Ni-Ti of about 115 °C at most and the additions; the authors’ statement that all but Hf and Zr raise cost greatlyCarl et al. (2017)
Reference 9 https://doi.org/10.3390/met7110511
Sourced
B2 austenite, B19′ martensite and R-phase; recoverable deformation (up to about 10%, cited), tensile elongation above 30% (cited), poor workability and complex shapes by SLM; the summary of SLM microstructure and transformation behaviorWang et al. (2018)
Reference 10 https://doi.org/10.3390/ma11091683
Sourced
Differences in microstructure and transformation path for rapidly solidified Ti49Ni51 heat-treated at 723, 773 and 823 K; small hysteresis at 773 KAbstract of Li et al. (2019)
Reference 11 https://doi.org/10.3390/ma12162539
Sourced
That the room-temperature tensile behavior of nitinol ribbon depends on thermomechanical history and that the amount and state of R-phase set the first plateau stressAbstract of NASA, Lach et al. (2002)
Reference 18 https://ntrs.nasa.gov/citations/20030014802
Sourced
For 55NiTi specimens from the same heat and batch, the test procedure changes the transformation strain by 0.005–0.01 mm/mm and the work output by about 2 J/cm3; transformation temperatures differed only with external stress; the authors’ statement that standard procedures for mechanical and thermomechanical properties are not in place (2008)Abstract of NASA, Padula et al. (2008)
Reference 17 https://ntrs.nasa.gov/citations/20080047419
Sourced
Superelastic stress of Fe–Mn–Al–Ni varying by 0.53 MPa/°C (−196 to 240 °C, one example) and the magnetic contribution to the small transformation entropy change; that the rise of superelastic stress with temperature limits use over a wide temperature rangeAbstract of Omori et al. (2011)
Reference 12 https://doi.org/10.1126/science.1202232
Sourced
A superelastic strain of a ferrous alloy above 13%, tensile strength above 1 GPa, almost twice the maximum superelastic strain of Ni-Ti, a large damping capacity. The statement that Ni-Ti was then (2010) the only superelastic material in practical use. That Ni-Ti and Cu-Zn-Al show reversible strains above several percentAbstract of Tanaka et al. (2010)
Reference 13 https://doi.org/10.1126/science.1183169
Sourced
The three groups of high-temperature shape memory alloys (Ms 100–400, 400–700, above 700 °C), the criteria (recoverable strain, long-term stability, resistance to plastic deformation and creep, environmental resistance), the problems (workability and material cost), and applications in Ti-Ni-Pd and Ti-Ni-PtAbstract of Ma et al. (2010)
Reference 14 https://doi.org/10.1179/095066010X12646898728363
Sourced
Ni30Pt20Ti50 (transformation temperatures above 230 °C) and Ni20Pt30Ti50 (above 530 °C); 100% no-load recovery up to the fracture limit (3–4%); maximum work of the 20Pt alloy of nearly 9 J/cm3; zero work under load for the 30Pt alloy and the reasonAbstract of NASA, Noebe et al. (2005)
Reference 16 https://ntrs.nasa.gov/citations/20050185200
Sourced
Ductility of Cu–Al–Mn, superelasticity and the one-way and two-way memory effects, control of grain size and texture, and the medical guidewire applicationAbstract of Sutou et al. (2008)
Reference 15 https://doi.org/10.1179/174328408X302567
Sourced
The scope of the review of aerospace applications (atmospheric flight and space flight)Abstract of Hartl and Lagoudas (2007)
Reference 22 https://doi.org/10.1243/09544100JAERO211
Sourced
A full-scale variable geometry chevron with shape memory alloy actuators, control of tip immersion by regulating heating, and tests in Boeing’s Nozzle Test FacilityAbstract of NASA, Cabell et al. (2004)
Reference 19 https://ntrs.nasa.gov/citations/20040139184
Sourced
Adaptive chevrons using high-temperature shape memory alloys that operate in both the fan and core flowsNASA Tech Briefs (2011)
Reference 20 https://ntrs.nasa.gov/citations/20110012201
Sourced
The superelastic spring tire (about 30 times the reversible deformation of a steel spring), NASA Glenn Research Center and Goodyear, finite element analysisAbstract of NASA, Naghipour et al. (2026)
Reference 21 https://ntrs.nasa.gov/citations/20260008869
Sourced
Cooling and response time of actuators (several seconds), forced cooling, the features of wires (3–4% or less), coils and bundles, and the energy density of 5000–25,000 kJ/m3 against 40–70 kJ/m3 for skeletal muscleRomančík et al. (2026)
Reference 23 https://doi.org/10.3390/act15030162
Sourced
Above Af, a shorter fatigue life and lower energy dissipation as temperature rises (DMA)Abstract of Lin et al. (2020)
Reference 24 https://doi.org/10.3390/ma13030573
Sourced
With pre-strain warm laser shock peening, a bending fatigue life above 5 million cycles at a maximum surface tensile strain of 1.94%, more than 3000 times that of untreated nanocrystalline NiTi (the authors’ claim)Abstract of Yan et al. (2026)
Reference 25 https://doi.org/10.1038/s41467-026-72857-z
Sourced
That the distinction between structural and functional fatigue appears in a title, and that a review of Ti–Ni-based alloys exists (content not verified)Bibliographic data confirmed through Crossref
Reference 26 https://doi.org/10.1016/j.msea.2003.10.327
Reference 27 https://doi.org/10.1016/j.pmatsci.2004.10.001
Sourced
Numbers, titles and dates of establishment, revision and confirmation of JIS H 7001, H 7101, H 7103, H 7105, H 7106 and H 7107. JIS Z 2241 and ISO 6892-1:2019 (MOD)JISC, JSA and ISO
Reference 32 https://www.jisc.go.jp/app/jis/general/GnrJISNumberNameSearchList?show&jisStdNo=H7
Reference 33 https://www.jisc.go.jp/app/jis/general/GnrJISSearch.html
Reference 30 https://www.jisc.go.jp/app/jis/general/GnrJISNumberNameSearchList?show&jisStdNo=Z2241
Reference 31 https://webdesk.jsa.or.jp/preview/pre_jis_z_02241_000_000_2022_j_ed10_ch.pdf
Reference 29 https://www.iso.org/standard/78322.html
Sourced
Numbers, titles and editions of ASTM F2004, F2082/F2082M, F2063, F2633, F2005, F2516, F2129, E2948, F2477 and F3211 (listed as FDA-recognized consensus standards). The title and 2nd edition of ISO 10993-15:2019FDA database and ISO catalogue page
Reference 3 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=nickel-titanium&Search=Search
Reference 4 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?title=nitinol&Search=Search
Reference 5 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?referencenumber=F3211&Search=Search
Reference 28 https://www.iso.org/standard/68937.html
Sourced
Ni 50.0, 50.8 and 51.0 at.% as 55.08, 55.87 and 56.07 wt.%. The ±5 and ±20 K from applying about 100 K per at.% to ±0.05 and ±0.2 at.%. The stress of 200–400 MPa back-calculated from 2 J/cm3. A plateau of about 240 MPa at Ms = 0 °C, 37 °C and 6.5 MPa/°C; about 60–70 MPa per 10 °C difference in Ms; ±18–21 MPa for ±3 °C (±1.6 MPa for the Fe-based alloy). For a 100 °C rise, about 600–700 and 350–400 MPa for NiTi and about 53 MPa for the Fe-based alloy. The time for 10 million cycles (about 116 days at 1 Hz, about 55.6 hours at 50 Hz, about 46 hours at 60 Hz). 200 MPa × 4% = 8 J/cm3, and a ratio to skeletal muscle of about 114 to 200Our calculation. All are simplifications (a composition sensitivity for shape memory alloys in general, constant slopes, constant stress, continuous testing) and are not values for real productsOur calculation
The change of NiTi’s transformation temperature per at.% of Ni, dedicated ISO, IEC and IEEE standards for shape memory alloys, the JIS-ISO correspondence, the text of the standards, regulation and markets in each country, and a quantitative comparison of built partsNot confirmed within the scope of our research, so not stated (no standards for “shape memory alloy” or “nitinol” in a search of the ISO catalogue, 10 October 2026; this article’s own note)Commentary
The readings “the transformation temperature is a function of composition and history”, “do not read superelasticity from Af alone”, “the five items of a fatigue number” and “high temperature is a matter of strength reversal and stability”; the correspondence between the guidance items and the sections of this article; the arrangement of the table of standardsOur own organization and commentary based on published material. These are not views stated by any organization or companyCommentary
That Figs. 2 to 6 are explanatory drawings and not reproductions of micrographs or measured curves, and that Figs. 1 and 7 are AI-generated imagesThis article’s own noteCommentary

Last updated: 10 October 2026. Sources are limited to primary material (peer-reviewed papers, the FDA guidance and regulatory science tool, NASA technical reports, and the databases of the Japanese Industrial Standards Committee, ISO and the FDA). We have not read the text of the standards. Because the article includes organization of structure and readings of materials design, these are marked as “commentary” and kept apart from sourced facts. We could not confirm, and therefore do not state, the change of NiTi’s transformation temperature per at.% of Ni, dedicated ISO, IEC or IEEE standards for shape memory alloys, the text of the standards and the test conditions of ASTM standards, the treatment of nitinol in Japanese and EU medical device regulation, prices and supply in any country, or a quantitative comparison of additively built parts. The values of transformation temperature, stress, strain and life are results for specific alloys, heat treatments and test conditions, and cannot be generalized to other alloys or products. We give no medical advice and no ranking of any product or company. Figs. 2 to 6 are vector drawings and Figs. 1 and 7 are AI-generated images; none of them shows an actual micrograph or a real product.

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