INSTITUTION PROFILE / BIOSENSORS
ISO (International Organization for Standardization)
The publisher of the international standards that fix how glucose meters and diagnostic tests are measured and made
ISO is a network of national standards bodies with its Central Secretariat in Geneva, Switzerland. It does not review or approve biosensors or medical devices. What it publishes are international standards, among them requirements for blood glucose monitoring systems, good practice for clinical performance studies of in vitro diagnostic (IVD) devices, quality management, risk management and biological evaluation. ISO standards are voluntary and carry no legal force of their own. Even so, the U.S. Food and Drug Administration (FDA) has built ISO 13485 into its quality system regulation, and in the European Union, European standards whose references the European Commission has published in the Official Journal give manufacturers a "presumption of conformity". This profile looks at one question: how much influence ISO actually has over biosensors, in terms of the kind of power it holds and how far that power reaches.
- ISO in 30 seconds
- What kind of body it is: the four types of influence
- What it does for biosensors
- How far its influence reaches (powers and geography)
- How standards enter regulation
- Outlook
- Glossary, references and claim-to-source audit
1. ISO in 30 seconds
What ISO sets is a common yardstick: what a blood glucose monitoring system should be required to do, and how a clinical performance study should be planned and recorded. It does not grant permission to sell a product. ISO itself states that its standards are "voluntary", contain no contractual, legal or statutory requirements, and do not replace national law Sourced. The standards still matter to sensor developers because regulators cite them, and that can make them the de facto benchmark. In the United States, the FDA's Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference. In the EU, standards whose references the Commission has published in the Official Journal give a presumption of conformity Sourced. The reverse also happens: in its guidance on self-monitoring blood glucose systems, the FDA says that the criteria in ISO 15197 are not sufficient to protect lay users. Meeting a standard does not guarantee that a regulator's bar has been met Sourced.
2. What kind of body it is: the four types of influence
Unlike the companies in this series, the institutions that appear in biosensor coverage do not make sensors. What separates them is the route by which they influence the industry, and that gives four types.
3. What it does for biosensors
The table below lists the main ISO standards that bear on biosensors (blood glucose meters, continuous glucose monitoring and in vitro diagnostic devices), as described on ISO's own standard pages. Different technical committees write them: ISO/TC 212 (medical laboratories and in vitro diagnostic systems) covers glucose monitoring and IVD testing, ISO/TC 210 covers quality management for medical devices, and ISO/TC 194 covers biological evaluation and clinical investigation Sourced. The standards themselves are sold (the prices shown on the standard pages range from CHF 181 to CHF 272), so this article relies on each page's abstract and status information.
| Area | Standard (as titled by ISO) | What it covers, edition and status |
|---|---|---|
| Requirements for self-testing glucose meters | ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus | Specifies requirements for systems that measure glucose in capillary blood, design verification procedures, and validation of performance by intended users. It addresses self-measurement by lay persons. Second edition, published May 2013 and confirmed at review in 2018. Its current stage is "to be revised" (90.92), and a committee draft of a third edition, ISO/CD 15197, is under development (stage 30.60) |
| Clinical performance studies of IVDs | ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice | Good study practice for planning, conducting, recording and reporting studies that assess the clinical performance and safety of IVDs for regulatory purposes, including the responsibilities of sponsor and principal investigator and the protection of subjects. Analytical performance studies are outside its scope. Published May 2019, confirmed in 2025 |
| Quality management | ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes | The international standard for quality management systems in the design and manufacture of medical devices. Third edition, published March 2016, confirmed in 2025 |
| Risk management | ISO 14971:2019 Medical devices — Application of risk management to medical devices | Terminology, principles and a process for risk management of medical devices, including IVDs. It does not fix acceptable risk levels; the manufacturer sets objective criteria. Third edition, published December 2019, confirmed in 2025 |
| Biocompatibility | ISO 10993-1:2025 Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process | Requirements and principles for evaluating the biological safety of devices that contact the body, within a risk management process. Sixth edition, published November 2025. The 2018 edition has been withdrawn |
| Laboratory quality and competence | ISO 15189:2022 Medical laboratories — Requirements for quality and competence | Requirements for quality and competence in medical laboratories. It states that it also applies to point-of-care testing (POCT). Fourth edition, published December 2022. The earlier ISO 22870:2016 on POCT has been withdrawn |
| Clinical investigation of medical devices | ISO 14155:2026 Clinical investigation of medical devices for human subjects — Good clinical practice | Good clinical practice for clinical investigations of medical devices in human subjects. Fourth edition, published March 2026 (the 2020 edition is withdrawn). It does not apply directly to IVDs; ISO 20916 notes that for an integrated system of IVD and device (its example is a lancet, a test strip and a glucose meter), aspects of both standards can be considered |
The accuracy requirement for glucose measurement sits in ISO 15197, while the framework for evaluating the biological safety of materials that touch the body sits in ISO 10993-1, and different technical committees look after them Sourced. For someone choosing electrode materials or a skin adhesive for a sensor, the first is the yardstick for "how do we prove the measurement performs", and the second for "can we justify putting this material in contact with the body". Which evaluation items apply to which material depends on factors such as the site and duration of contact, but the specific items and values are in the standard text, which is sold, and we have not reviewed them Not yet confirmed. Skin adhesion for patch sensors is covered in our explainer on patch-type sensors and skin adhesives.
4. How far its influence reaches (powers and geography)
| Aspect | What ISO has | What ISO does not have |
|---|---|---|
| Powers | It publishes international standards on the basis of agreement in its technical committees, setting common benchmarks for testing, quality and risk | Any power to compel adoption, or to approve or certify products. Its standards are "voluntary", and national law takes precedence |
| Geography | 177 members, one per country. Members adopt and sell ISO standards nationally, and ISO standards serve as an international reference point | The regulations themselves. US, EU and Japanese rules are set by their own authorities |
| United States | The FDA's Quality Management System Regulation (QMSR, 21 CFR Part 820) incorporates ISO 13485:2016 by reference. The final rule was published on 2 February 2024 and took effect on 2 February 2026. The FDA's database of recognized consensus standards lists voluntary standards for which it accepts a declaration of conformity | Meeting an ISO standard does not decide an FDA review such as a 510(k). In its guidance on self-monitoring blood glucose systems the FDA says ISO 15197 alone is not enough |
| European Union | Devices that conform to harmonised standards whose references are published in the Official Journal are presumed to conform to the requirements those standards cover (Article 8 of the IVD Regulation, Regulation (EU) 2017/746). The IVDR list includes EN ISO 13485:2016, EN ISO 14971:2019 and EN ISO 20916:2024, among others | No presumption for standards that are not on the list (we did not find ISO 15197 in the IVDR list generated on 17 June 2026). ISO publishes standards; it is not the body that certifies products |
| Japan | The QMS Ordinance for medical devices and IVDs (MHLW Ordinance No. 169 of 2004) was enacted with ISO 13485 in mind, and was amended on 26 March 2021 (MHLW Ordinance No. 60 of 2021) following the revision of ISO 13485 | Power over Japan's approval and certification system and its reviews (the roles of the Ministry of Health, Labour and Welfare and PMDA). We have not checked how Japanese Industrial Standards (JIS) correspond to these ISO standards |
| Scale and funding | National members take part, and ISO funds its work in part through sales of its standards (ISO's own description) | The headcount of the Central Secretariat could not be found on ISO's website |
The FDA's guidance (issued 29 September 2020, for 510(k) submissions of over-the-counter self-monitoring blood glucose systems) acknowledges that many manufacturers design their validation studies on the basis of ISO 15197. It then says that the ISO 15197 criteria are not sufficient to adequately protect lay users, giving as reasons that the standard does not adequately address performance in the low-glucose range or across test strip lots, and it recommends its own study designs Sourced. The guidance also states that it contains nonbinding recommendations. In short, an ISO standard is a common foundation, but what a company must show in order to sell in a given region is decided by that region's regulator.
5. How standards enter regulation
An ISO standard affects real products when a national or regional authority takes it into its own system. We were able to confirm three routes from primary sources.
| Technical committee | Scope (per ISO) | Secretariat and participation (as shown on 3 October 2026) |
|---|---|---|
| ISO/TC 212 Medical laboratories and in vitro diagnostic systems | Quality management, pre- and post-analytical procedures, analytical performance, laboratory safety, reference systems and quality assurance. It excludes generic quality management (TC 176) and quality management for medical devices (TC 210) | Secretariat: ANSI (United States). Created 1994. 45 participating members and 32 observing members. 56 published standards and 22 under development (including updates) |
| ISO/TC 210 Quality management for products with a health purpose, including medical devices | Requirements and guidance on quality management and related general aspects for products with a health purpose | Secretariat: ANSI (United States). Created 1994 |
| ISO/TC 194 Biological and clinical evaluation of medical devices | Biological and clinical evaluation of medical and dental materials and devices, biological test methods, and good clinical practice principles for clinical investigations in humans | Secretariat: DIN (Germany). Created 1988 |
Note: for these three committees the secretariats, which run the day-to-day standards work, are held by the United States (ANSI) and Germany (DIN). We did not check Japan's involvement (through JISC and others) Not yet confirmed.
Where our company profiles in this series (in preparation) discuss the regulatory position of glucose meters, CGM or IVDs, these standards appear as yardsticks for quality, risk and testing. What a given company actually did under which standard is written there only to the extent that the company's own publications confirm it. The differences between regulatory pathways (510(k), De Novo, PMA, MDR/IVDR) are covered in our explainer on medical device approval categories and home use, and continuous glucose monitoring in our explainer of that name.
6. Outlook
| What we can read | Primary information behind it | Type |
|---|---|---|
| A third edition of ISO 15197 is in preparation. The 2013 edition is at the "to be revised" (90.92) stage | ISO's standard page for ISO/CD 15197 (stage 30.60, close of comment period). No publication date is given | Sourced |
| ISO 10993-1:2025 has been published, and EN ISO 10993-1:2025 now appears in the Commission's list of harmonised standards under the Medical Device Regulation (MDR) | ISO's standard page (published November 2025). The Commission's list generated on 17 June 2026 | Sourced |
| The 2026 edition of ISO 14155 (fourth edition) is not yet in the Commission's MDR list, which still shows EN ISO 14155:2020 with amendment A11:2024 | ISO's standard page (published March 2026). The Commission's MDR list generated on 17 June 2026 | Not yet confirmed |
| Even when a revised ISO 15197 appears, the FDA may not simply use it to evaluate self-monitoring blood glucose systems | The FDA's guidance finds the current ISO 15197 criteria insufficient and recommends its own approach. The content of the revision and the FDA's treatment of it are not yet public | Inference |
7. Glossary
- Technical committee (TC)
- An ISO committee that drafts standards for a field. Experts come from member countries, and a secretariat run by one member manages the work.
- Harmonised standard
- In the EU, a European standard drafted by a European standards body whose reference the Commission has published in the Official Journal. Conformity with it gives a presumption of conformity with the requirements it covers.
- CEN
- The European Committee for Standardization. It may adopt ISO standards as European standards (EN ISO).
- QMSR
- The FDA's Quality Management System Regulation (21 CFR Part 820). Since 2 February 2026 it incorporates ISO 13485:2016 by reference.
- Recognized consensus standard
- A voluntary standard for which the FDA has decided to accept a declaration of conformity. The list is published in an FDA database.
- IVD
- In vitro diagnostic medical device: an instrument or reagent that examines a specimen such as blood outside the body. A glucose meter and its test strips are a typical example.
8. References
- ISO About ISO (26,515 standards and other deliverables, 177 members, 844 technical committees and subcommittees, active since 1946). https://www.iso.org/about-us.html
- ISO Structure and governance (independent non-governmental organisation, Central Secretariat in Geneva). https://www.iso.org/structure.html
- ISO Members (one member per country, member categories, national adoption and sale of standards). https://www.iso.org/members.html
- ISO Foreword - Supplementary information (ISO standards are voluntary and do not replace national law). https://www.iso.org/foreword-supplementary-information.html
- ISO ISO 15197:2013 standard page (title, abstract, second edition, published May 2013, confirmed 2018, stage 90.92, price CHF 181). https://www.iso.org/standard/54976.html
- ISO ISO/CD 15197 standard page (committee draft of a third edition, under development, stage 30.60, intended to replace ISO 15197:2013). https://www.iso.org/standard/91142.html
- ISO ISO 20916:2019 standard page (title, abstract, published May 2019, confirmed 2025, TC 212, price CHF 225). https://www.iso.org/standard/69455.html
- ISO ISO 13485:2016 standard page (title, third edition, published March 2016, confirmed 2025, TC 210, price CHF 235). https://www.iso.org/standard/59752.html
- ISO ISO 14971:2019 standard page (title, third edition, published December 2019, confirmed 2025, does not specify acceptable risk levels, price CHF 196). https://www.iso.org/standard/72704.html
- ISO ISO 10993-1:2025 standard page (title, sixth edition, published November 2025, TC 194, price CHF 196). https://www.iso.org/standard/10993-1
- ISO ISO 10993-1:2018 standard page (withdrawn, revised by ISO 10993-1:2025). https://www.iso.org/standard/68936.html
- ISO ISO 15189:2022 standard page (title, abstract, also applicable to POCT, fourth edition, published December 2022, earlier ISO 22870:2016 withdrawn, price CHF 225). https://www.iso.org/standard/76677.html
- ISO ISO 14155:2026 standard page (title, fourth edition, published March 2026, does not apply directly to IVDs, price CHF 272). https://www.iso.org/standard/14155
- ISO ISO 14155:2020 standard page (withdrawn, revised by ISO 14155:2026). https://www.iso.org/standard/71690.html
- ISO ISO/TC 212 Medical laboratories and in vitro diagnostic systems (scope, ANSI secretariat, created 1994, 45 participating members, 32 observing members). https://www.iso.org/committee/54916.html
- ISO ISO/TC 210 (scope, ANSI secretariat, created 1994). https://www.iso.org/committee/54892.html
- ISO ISO/TC 194 Biological and clinical evaluation of medical devices (scope, DIN secretariat, created 1988). https://www.iso.org/committee/54508.html
- U.S. Food and Drug Administration (FDA) Quality Management System Regulation (QMSR) (published 2 February 2024, effective 2 February 2026, incorporates ISO 13485:2016 by reference). https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr
- FDA Guidance "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" (issued 29 September 2020; the FDA's view of ISO 15197; nonbinding recommendations). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/self-monitoring-blood-glucose-test-systems-over-counter-use
- FDA Recognized Consensus Standards: Medical Devices (database of voluntary consensus standards for which the FDA accepts a declaration of conformity). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
- European Commission Harmonised standards: In vitro diagnostic medical devices (Regulation (EU) 2017/746 applicable from 26 May 2022; Implementing Decision (EU) 2021/1195 and its amendments). https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en
- European Commission Summary list of harmonised standards for the IVD Regulation (generated 17 June 2026; EN ISO 13485:2016, EN ISO 14971:2019, EN ISO 20916:2024 and others). https://single-market-economy.ec.europa.eu/document/download/bea20714-7793-43ad-9a76-ef2a96ac8e45_en?filename=SummaryListForLegislation_2017_746%201.30.2026.pdf
- European Commission Harmonised standards: Medical devices (Regulation (EU) 2017/745 applicable from 26 May 2021; Implementing Decision (EU) 2021/1182 and its amendments). https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en
- European Commission Summary list of harmonised standards for the Medical Device Regulation (generated 17 June 2026; EN ISO 10993-1:2025, EN ISO 14155:2020 and others). https://single-market-economy.ec.europa.eu/document/download/40f686be-acf4-4a0b-b6d2-20a00f46a8bc_en?filename=SummaryListForLegislation_20.10.2025.pdf
- European Union Regulation (EU) 2017/746 (IVD Regulation), Article 8 "Use of harmonised standards". https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng
- Osaka Prefecture Notice on the revision of the QMS Ordinance (in Japanese): the ordinance was enacted with ISO 13485 in mind and amended on 26 March 2021 (MHLW Ordinance No. 60 of 2021). https://www.pref.osaka.lg.jp/yakumu/iryoukikikannkei/qms_amendment.html
9. Claim-to-source audit
| Claim in the text | Type | Source |
|---|---|---|
| Size and standing: 26,515 standards, 177 members, 844 committees, active since 1946, independent non-governmental body, Central Secretariat in Geneva | Sourced | Reference 1 https://www.iso.org/about-us.html Reference 2 https://www.iso.org/structure.html |
| One member per country; members adopt and sell standards nationally | Sourced | Reference 3 https://www.iso.org/members.html |
| ISO standards are voluntary and do not replace national law | Sourced | Reference 4 https://www.iso.org/foreword-supplementary-information.html |
| ISO 15197:2013: title, abstract, second edition, May 2013, confirmed 2018, stage 90.92 | Sourced | Reference 5 https://www.iso.org/standard/54976.html |
| ISO/CD 15197 (third edition committee draft) under development, stage 30.60 | Sourced | Reference 6 https://www.iso.org/standard/91142.html |
| ISO 20916:2019: title, abstract, analytical performance studies out of scope, note on ISO 14155, confirmed 2025 | Sourced | Reference 7 https://www.iso.org/standard/69455.html |
| ISO 13485:2016: title, third edition, March 2016, confirmed 2025, TC 210 | Sourced | Reference 8 https://www.iso.org/standard/59752.html |
| ISO 14971:2019: title, third edition, does not specify acceptable risk levels | Sourced | Reference 9 https://www.iso.org/standard/72704.html |
| ISO 10993-1:2025: title, sixth edition, November 2025; the 2018 edition is withdrawn | Sourced | Reference 10 https://www.iso.org/standard/10993-1 Reference 11 https://www.iso.org/standard/68936.html |
| ISO 15189:2022 also applies to POCT; ISO 22870:2016 withdrawn | Sourced | Reference 12 https://www.iso.org/standard/76677.html |
| ISO 14155:2026: title, fourth edition, March 2026, not directly applicable to IVDs; the 2020 edition is withdrawn | Sourced | Reference 13 https://www.iso.org/standard/14155 Reference 14 https://www.iso.org/standard/71690.html |
| Scope, secretariat, creation year and participation of TC 212, TC 210 and TC 194 | Sourced | Reference 15 https://www.iso.org/committee/54916.html Reference 16 https://www.iso.org/committee/54892.html Reference 17 https://www.iso.org/committee/54508.html |
| Prices shown on the standard pages (CHF 181 to 272) | Sourced | Our own tally of the prices on References 5, 7, 8, 9, 10, 12 and 13 |
| FDA QMSR incorporates ISO 13485:2016 by reference; published 2 February 2024, effective 2 February 2026 | Sourced | Reference 18 https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr |
| FDA guidance on self-monitoring blood glucose systems: ISO 15197 criteria not sufficient for lay users; low-glucose range and strip lots; nonbinding; issued 29 September 2020 | Sourced | Reference 19 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/self-monitoring-blood-glucose-test-systems-over-counter-use |
| The FDA recognized-standards database lists voluntary consensus standards for which a declaration of conformity is accepted | Sourced | Reference 20 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm |
| IVD Regulation applicable from 26 May 2022; Implementing Decision (EU) 2021/1195 | Sourced | Reference 21 https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en |
| IVDR list includes EN ISO 13485:2016, EN ISO 14971:2019 and EN ISO 20916:2024; ISO 15197 not found | Sourced | Reference 22 https://single-market-economy.ec.europa.eu/document/download/bea20714-7793-43ad-9a76-ef2a96ac8e45_en?filename=SummaryListForLegislation_2017_746%201.30.2026.pdf |
| MDR applicable from 26 May 2021; Implementing Decision (EU) 2021/1182 | Sourced | Reference 23 https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en |
| MDR list includes EN ISO 10993-1:2025 and EN ISO 14155:2020 (with A11:2024) | Sourced | Reference 24 https://single-market-economy.ec.europa.eu/document/download/40f686be-acf4-4a0b-b6d2-20a00f46a8bc_en?filename=SummaryListForLegislation_20.10.2025.pdf |
| Conformity with harmonised standards gives a presumption of conformity (Article 8(1), Regulation (EU) 2017/746) | Sourced | Reference 25 https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng |
| Japan's QMS Ordinance was enacted with ISO 13485 in mind and amended on 26 March 2021 (MHLW Ordinance No. 60 of 2021) | Sourced | Reference 26 https://www.pref.osaka.lg.jp/yakumu/iryoukikikannkei/qms_amendment.html |
| The four-type classification of institutions and the three routes in Fig. 2 | Our calculation | Our own grouping, based on References 18, 19 and 21 to 26 |
| The materials engineer's view (performance bar versus material safety) | Our calculation | Our own reading, based on References 5 and 10 |
| Specific evaluation items and values for materials, the publication date of the revised ISO 15197, adoption of ISO 14155:2026 in the EU, JIS correspondence, Central Secretariat headcount, Japan's involvement | Not yet confirmed | Not found on the official pages. This article does not estimate them |
| A revised ISO 15197 may not be used by the FDA as it stands | Inference | Our reading of the FDA position (Reference 19) and the unpublished revision (Reference 6); this article's interpretation |
Last updated 3 October 2026 / Troy Technical
This article summarises standards and regulation from the official materials of ISO, the FDA, the European Commission and others. It is not advice on diagnosis, treatment or the reading of any individual's measurements. Items marked "Inference" are this article's reading of the primary information.