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Reader task: find which ISO or IEC standard answers which question about a medical device, and what a supplier’s standards claim actually means. This page describes products and general use; it is not medical advice.
ISO and IEC publish medical device standards through technical committees. ISO/TC 210 covers quality management and corresponding general aspects for products with a health purpose, including connectors for liquids and gases; ISO/TC 194 covers biological evaluation. This page maps the main standards to the question each one answers, shows which editions ISO lists as withdrawn or replaced as of 2026-11-01, and explains how US regulators treat standards.
Main ISO and IEC medical device standards by topic
This is a map of what each standard covers, not a ranking. Titles and edition years are taken from ISO’s own catalogue pages, checked on 2026-11-01.
| Question | Standard (edition listed by ISO) | What it covers |
|---|---|---|
| Is there a quality management system? | ISO 13485:2016 | Quality management systems, requirements for regulatory purposes |
| How are risks managed? | ISO 14971:2019; ISO/TR 24971:2020 (guidance) | Application of risk management to medical devices |
| Is the material biologically safe? | ISO 10993 series, for example ISO 10993-1:2025 | Requirements and general principles for evaluating biological safety within a risk management process |
| What do the label symbols mean? | ISO 15223-1:2021 | Symbols used with information supplied by the manufacturer, Part 1 |
| What information must come with the device? | ISO 20417:2026 (2021 edition withdrawn) | Information to be supplied by the manufacturer |
| Is the electrical equipment safe? | IEC 60601-1 | Medical electrical equipment (see the linked guide for edition details) |
| How is device software built? | IEC 62304:2006 (Amd 1:2015) | Medical device software, software life cycle processes |
| Was usability engineered in? | IEC 62366-1:2015 (Amd 1:2020) | Usability engineering |
| Will small-bore connectors fit? | ISO 80369-1:2025, -3:2016, -7:2021 | Small-bore connectors: general requirements; enteral applications (-3); intravascular or hypodermic applications (-7) |
Biological evaluation parts listed by ISO
ISO/TC 194 lists ISO 10993-1:2025 plus parts including -3:2026, -4:2017 (with Amd 1:2025), -5:2009 (in vitro cytotoxicity), -6:2026, -7:2026 (ethylene oxide residuals), -10:2021, -11:2017, -12:2021, -17:2023, -18:2020 and -23:2021 (irritation). Our guides cover several of these parts individually, including ISO 10993-4, -6 and -11.
Are ISO standards for medical devices mandatory?
Not by themselves. FDA states that manufacturers are encouraged to use FDA-recognized consensus standards in premarket submissions and that conformance is voluntary, unless a standard is incorporated by reference into regulation (FDA Division of Standards and Conformity Assessment, checked 2026-11-01).
The main US example of incorporation by reference is the Quality Management System Regulation (QMSR). FDA states the rule is effective February 2, 2026 and incorporates ISO 13485:2016 and clause 3 of ISO 9000:2015 by reference. Where an ISO 13485 clause conflicts with the Federal Food, Drug, and Cosmetic Act or its implementing regulations, the Act and regulations control (FDA QMSR page, checked 2026-11-01).
Withdrawn and replaced editions
Many lists online still show older editions. The table below is what ISO’s catalogue listed on 2026-11-01.
| Standard | Status as listed by ISO, 2026-11-01 |
|---|---|
| ISO 13485:2016 | Published (Edition 3, 2016); last reviewed and confirmed in 2025, so this version remains current |
| ISO 14971:2007 | Withdrawn; ISO 14971:2019 listed |
| ISO 10993-1:2018 | Withdrawn; ISO 10993-1:2025 listed |
| ISO 15223-1:2016 | Withdrawn; ISO 15223-1:2021 listed, with Amd 1:2025 |
| ISO 20417:2021 | Withdrawn; ISO 20417:2026 listed |
| ISO 594-1:1986 and ISO 594-2:1998 (Luer) | Listed as withdrawn |
How to read a supplier’s standards claim
Under US rules a manufacturer may submit a declaration of conformity to a recognized consensus standard (21 U.S.C. 360d(c)(1)(B)); FDA says appropriate use may reduce the supporting test documentation needed in a premarket submission. Recognition is the process by which FDA identifies standards eligible for such a declaration. FDA records each in its Recognized Consensus Standards Database with a recognition number and a Supplemental Information Sheet, and applicants identify referenced standards on Form FDA 3514. See our entry on FDA-recognized consensus standards.
When a claim names a standard, the useful points to check are the full designation including the edition year, whether the edition is still the one ISO lists, and what document backs the claim, such as a declaration of conformity or a certificate to ISO 13485.
FAQ
What is the difference between ISO 13485 and ISO 14971?
ISO 13485:2016 sets quality management system requirements for regulatory purposes. ISO 14971:2019 covers the application of risk management to medical devices. FDA notes that the QMSR framework, built on ISO 13485, now specifically requires risk management.
Is there a single list of all medical device standards?
ISO/TC 210 and ISO/TC 194 each publish a catalogue of their standards. In the US, FDA maintains the Recognized Consensus Standards Database and publishes recognition lists in the Federal Register, usually at least twice a year.
Sources
All sources below were checked on 2026-11-01.
- FDA, Division of Standards and Conformity Assessment, https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/division-standards-and-conformity-assessment (checked 2026-11-01).
- FDA, Quality Management System Regulation (QMSR), https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr (checked 2026-11-01).
- ISO, ISO 13485:2016, https://www.iso.org/standard/59752.html (checked 2026-11-01).
- ISO/TC 210, https://www.iso.org/committee/54892.html and catalogue https://www.iso.org/committee/54892/x/catalogue/p/1/u/0/w/0/d/0 (checked 2026-11-01).
- ISO/TC 194 catalogue, https://www.iso.org/committee/54508/x/catalogue/p/1/u/0/w/0/d/0 (checked 2026-11-01).
