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Medical Device Standards Reference Table (ISO, IEC, ASTM)

Medical device files cite dozens of standards, and it is easy to lose track of which one covers which question. This table lists the ISO, IEC and ASTM documents that quality and regulatory teams reach for most, grouped by area, so you can find the right reference in seconds.

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Standard	Subject	Area	Typical use in the quality system
ISO 13485	Quality management systems, requirements for regulatory purposes	QMS	Base QMS certification and audit criteria; also the model for the US QMSR
ISO 14971	Application of risk management to medical devices	Risk	Risk management plan, hazard analysis, risk control and benefit-risk file
ISO/TR 24971	Guidance on the application of ISO 14971	Risk	Practical guidance for building the risk management file
IEC 62304	Medical device software, software life cycle processes	Software	Software development plan, safety classification, verification and maintenance
IEC 81001-5-1	Health software and health IT systems safety and security, security activities in the product life cycle	Software	Cybersecurity activities for software in or as a device
AAMI TIR57	Principles for medical device security, risk management	Software	Security risk management that feeds the safety risk file
IEC 62366-1	Application of usability engineering to medical devices	Usability	Use specification, use-related risk analysis, summative evaluation
IEC 60601-1	Medical electrical equipment, basic safety and essential performance	Electrical safety	Electrical safety test plan and certification for powered devices
IEC 60601-1-2	Collateral standard, electromagnetic disturbances	Electrical safety	EMC testing and immunity levels for the intended environment
ISO 10993-1	Biological evaluation of medical devices within a risk management process	Biocompatibility	Biological evaluation plan by nature and duration of body contact
ISO 11135	Sterilization of health-care products, ethylene oxide	Sterilization	EO process development, validation and routine control
ISO 11137-1	Sterilization of health care products, radiation, requirements	Sterilization	Gamma, electron beam and X-ray process validation and control
ISO 11137-2	Sterilization of health care products, radiation, establishing the sterilization dose	Sterilization	Dose setting and substantiation using bioburden data
ISO 17665	Sterilization of health care products, moist heat	Sterilization	Steam sterilization development, validation and routine control
ISO 14937	General requirements for characterization of a sterilizing agent	Sterilization	Used where no dedicated process standard exists
ISO 11737-1	Sterilization of health care products, microbiological methods, bioburden determination	Sterilization	Bioburden testing method and product family approach
ISO 11737-2	Sterilization of health care products, microbiological methods, tests of sterility	Sterilization	Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11607-1	Packaging for terminally sterilized medical devices, materials, sterile barrier systems and packaging systems	Packaging	Material and sterile barrier system selection and qualification
ISO 11607-2	Packaging for terminally sterilized medical devices, validation requirements for forming, sealing and assembly processes	Packaging	Sealer IQ OQ PQ and seal parameter control
ASTM F1980	Accelerated aging of sterile barrier systems and medical devices	Packaging	Accelerated aging protocol used to support shelf-life claims
ASTM F88	Seal strength of flexible barrier materials	Packaging	Peel strength test for pouch and lidding seals
ASTM F1886	Determining integrity of seals for medical packaging by visual inspection	Packaging	Visual seal integrity inspection method
ASTM F2096	Detecting gross leaks in medical packaging by internal pressurization (bubble test)	Packaging	Gross leak test for sealed packages
ISO 14644-1	Cleanrooms and associated controlled environments, classification of air cleanliness by particle concentration	Cleanroom	Cleanroom classification and recertification
ISO 14644-2	Cleanrooms and associated controlled environments, monitoring to provide evidence of cleanroom performance	Cleanroom	Monitoring plan for cleanroom performance
ISO 15223-1	Medical devices, symbols to be used with information to be supplied by the manufacturer	Labeling	Standard label symbols such as manufacturer, lot, expiry, sterile
ISO 20417	Information to be supplied by the manufacturer	Labeling	General requirements for labels, IFU and accompanying information
ISO 14155	Clinical investigation of medical devices for human subjects, good clinical practice	Clinical	Clinical investigation planning, conduct and reporting
ISO 80369-1	Small-bore connectors for liquids and gases in healthcare applications, general requirements	Design	Connector misconnection risk reduction for small-bore devices

Standards are revised on their own cycles and regulators recognize specific editions. Confirm the current edition, any amendments and the recognition status (FDA Recognized Consensus Standards database, EU harmonized standards list) before citing in a submission.

Optional review of your standards applicability matrix

Send us your matrix and we will comment on how it could be linked to your ERP and quality records.

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How to use the table

Type a standard number, a keyword such as sterilization or packaging, or a lifecycle topic into the search box. Filter mentally by the Area column to see everything that applies to one discipline, for example all sterilization documents. Export the list to Excel to seed a standards applicability matrix, where you add columns for edition, applicability to your device family, evidence location and the person responsible for conformity.

Search by number, title word or area
Use Area to group by discipline
Export to Excel for your applicability matrix
Add edition and recognition columns yourself

How the standards fit together

ISO 13485 is the system level document. ISO 14971 sits beside it as the risk process that every design, production and post-market decision should feed. Product-specific standards then sit underneath: IEC 60601-1 for powered equipment, IEC 62304 for software, ISO 10993 for materials in body contact, and the sterilization and packaging families for sterile products. A technical file normally shows a clear line from the intended use to the risk file and then to the applicable standards.

Building a standards applicability matrix

For each device family list every standard that could apply, state whether it applies and why, record the exact edition used, and point to the report or protocol that demonstrates conformity. Where you apply only part of a standard, say which clauses. Reviewers and notified body auditors look for a documented rationale rather than a silent omission, so the exclusion rows matter as much as the inclusions.

Common mistakes

Teams often cite a standard without its edition, rely on an old edition after a revision changed requirements, or treat a collateral standard as optional. Another frequent gap is citing ISO 11607-1 for packaging materials but having no ISO 11607-2 validation of the sealing process. Keep the matrix under document control and review it when a standard is revised or a design change alters the device scope.

Frequently Asked Questions

Does this list replace the official standards?

No. It is a navigation aid with short subject descriptions. Requirements are in the published standards, which you must purchase from the issuing body. Always read the current edition and any amendments before claiming conformity.

Which standards are mandatory?

Standards are generally voluntary, but regulators recognize or harmonize specific ones and conformity gives a presumption of meeting related legal requirements. What is mandatory depends on your market, device class and the regulation that applies to you.

Why is ISO 14971 listed with ISO/TR 24971?

ISO 14971 contains the requirements. ISO/TR 24971 is a technical report that gives guidance on applying them. Teams usually keep both in the risk management procedure references.

Can I add my own rows?

The reference table is read-only, but you can export it to Excel and extend it with company standards, customer specifications and country requirements.

If your standards matrix, risk file and ERP quality records are maintained in separate places, Netray can discuss connecting them so evidence links stay current.

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