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

> Source: https://netray.co/tools/medical-device-standards-reference-iso-iec-astm
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Free Tools

## Short answer

A searchable lookup of the standards that medical device manufacturers cite in the QMS, design file and technical documentation, with area and typical use.

## Category

compliance-legal

## Industry

Medical Devices

## Audience

- Quality engineer
- Regulatory affairs
- Design engineer

## Tool

**Kind:** worksheet

**Mode:** reference

**Columns:**

#### Standard

**Key:** standard

**Type:** text

#### Subject

**Key:** title

**Type:** text

#### Area

**Key:** area

**Type:** text

#### Typical use in the quality system

**Key:** use

**Type:** text

**Rows:**

#### Quality management systems, requirements for regulatory purposes

**Standard:** ISO 13485

**Area:** QMS

**Use:** Base QMS certification and audit criteria; also the model for the US QMSR

#### Application of risk management to medical devices

**Standard:** ISO 14971

**Area:** Risk

**Use:** Risk management plan, hazard analysis, risk control and benefit-risk file

#### Guidance on the application of ISO 14971

**Standard:** ISO/TR 24971

**Area:** Risk

**Use:** Practical guidance for building the risk management file

#### Medical device software, software life cycle processes

**Standard:** IEC 62304

**Area:** Software

**Use:** Software development plan, safety classification, verification and maintenance

#### Health software and health IT systems safety and security, security activities in the product life cycle

**Standard:** IEC 81001-5-1

**Area:** Software

**Use:** Cybersecurity activities for software in or as a device

#### Principles for medical device security, risk management

**Standard:** AAMI TIR57

**Area:** Software

**Use:** Security risk management that feeds the safety risk file

#### Application of usability engineering to medical devices

**Standard:** IEC 62366-1

**Area:** Usability

**Use:** Use specification, use-related risk analysis, summative evaluation

#### Medical electrical equipment, basic safety and essential performance

**Standard:** IEC 60601-1

**Area:** Electrical safety

**Use:** Electrical safety test plan and certification for powered devices

#### Collateral standard, electromagnetic disturbances

**Standard:** IEC 60601-1-2

**Area:** Electrical safety

**Use:** EMC testing and immunity levels for the intended environment

#### Biological evaluation of medical devices within a risk management process

**Standard:** ISO 10993-1

**Area:** Biocompatibility

**Use:** Biological evaluation plan by nature and duration of body contact

#### Sterilization of health-care products, ethylene oxide

**Standard:** ISO 11135

**Area:** Sterilization

**Use:** EO process development, validation and routine control

#### Sterilization of health care products, radiation, requirements

**Standard:** ISO 11137-1

**Area:** Sterilization

**Use:** Gamma, electron beam and X-ray process validation and control

#### Sterilization of health care products, radiation, establishing the sterilization dose

**Standard:** ISO 11137-2

**Area:** Sterilization

**Use:** Dose setting and substantiation using bioburden data

#### Sterilization of health care products, moist heat

**Standard:** ISO 17665

**Area:** Sterilization

**Use:** Steam sterilization development, validation and routine control

#### General requirements for characterization of a sterilizing agent

**Standard:** ISO 14937

**Area:** Sterilization

**Use:** Used where no dedicated process standard exists

#### Sterilization of health care products, microbiological methods, bioburden determination

**Standard:** ISO 11737-1

**Area:** Sterilization

**Use:** Bioburden testing method and product family approach

#### Sterilization of health care products, microbiological methods, tests of sterility

**Standard:** ISO 11737-2

**Area:** Sterilization

**Use:** Tests of sterility performed in the definition, validation and maintenance of a sterilization process

#### Packaging for terminally sterilized medical devices, materials, sterile barrier systems and packaging systems

**Standard:** ISO 11607-1

**Area:** Packaging

**Use:** Material and sterile barrier system selection and qualification

#### Packaging for terminally sterilized medical devices, validation requirements for forming, sealing and assembly processes

**Standard:** ISO 11607-2

**Area:** Packaging

**Use:** Sealer IQ OQ PQ and seal parameter control

#### Accelerated aging of sterile barrier systems and medical devices

**Standard:** ASTM F1980

**Area:** Packaging

**Use:** Accelerated aging protocol used to support shelf-life claims

#### Seal strength of flexible barrier materials

**Standard:** ASTM F88

**Area:** Packaging

**Use:** Peel strength test for pouch and lidding seals

#### Determining integrity of seals for medical packaging by visual inspection

**Standard:** ASTM F1886

**Area:** Packaging

**Use:** Visual seal integrity inspection method

#### Detecting gross leaks in medical packaging by internal pressurization (bubble test)

**Standard:** ASTM F2096

**Area:** Packaging

**Use:** Gross leak test for sealed packages

#### Cleanrooms and associated controlled environments, classification of air cleanliness by particle concentration

**Standard:** ISO 14644-1

**Area:** Cleanroom

**Use:** Cleanroom classification and recertification

#### Cleanrooms and associated controlled environments, monitoring to provide evidence of cleanroom performance

**Standard:** ISO 14644-2

**Area:** Cleanroom

**Use:** Monitoring plan for cleanroom performance

#### Medical devices, symbols to be used with information to be supplied by the manufacturer

**Standard:** ISO 15223-1

**Area:** Labeling

**Use:** Standard label symbols such as manufacturer, lot, expiry, sterile

#### Information to be supplied by the manufacturer

**Standard:** ISO 20417

**Area:** Labeling

**Use:** General requirements for labels, IFU and accompanying information

#### Clinical investigation of medical devices for human subjects, good clinical practice

**Standard:** ISO 14155

**Area:** Clinical

**Use:** Clinical investigation planning, conduct and reporting

#### Small-bore connectors for liquids and gases in healthcare applications, general requirements

**Standard:** ISO 80369-1

**Area:** Design

**Use:** Connector misconnection risk reduction for small-bore devices

**Notes:** 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.

## Content

**Intro:** 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.

**Sections:**

#### How to use the table

**Body:** 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.

**Bullets:**

- 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

**Body:** 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

**Body:** 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

**Body:** 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.

**Cta:** 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.

**Faq:**

#### Does this list replace the official standards?

**Answer:** 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?

**Answer:** 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?

**Answer:** 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?

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

## Search terms

medical device standards list, ISO 13485 related standards, iec 62304 iso 14971 list, sterilization standards iso 11135 11137 17665, medical device packaging standards iso 11607, medical device harmonized standards list, iec 60601 standards list, medical device standards excel

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