ISO Standards for Medical Devices

Conformance to most consensus standards is voluntary. The main exception is ISO 13485:2016, which the Quality Management System Regulation (21 CFR Part 820) incorporates by reference, so its requirements are part of FDA regulation. For other standards, FDA maintains a recognized consensus standards database: a list of standards, by specific edition, against which FDA will accept a manufacturer's Declaration of Conformity in a premarket submission. Citing a recognized standard correctly can reduce the supporting documentation needed for that part of a submission.

Standards Most Relevant to an FDA Submission or Inspection

Where each standard matters in an FDA submission or inspection

Standard	What it covers	Where it matters
ISO 13485	Quality management systems for medical device organizations	FDA's QMSR (21 CFR Part 820) incorporates ISO 13485:2016 by reference (implementation guide →)
ISO 14971	Risk management applied throughout the device lifecycle	Referenced throughout design controls, submissions, and inspections (what FDA expects →)
ISO 10993 series	Biological evaluation of materials that contact the body	Biocompatibility section of a 510(k), PMA, or De Novo submission (what it is →)
IEC 62304	Software lifecycle processes for medical device software	Software documentation for any device with embedded or standalone software (practical guide →)
IEC 62366-1	Usability engineering applied to medical devices	Human factors section of a submission for devices with a meaningful use-error risk (usability engineering →)
IEC 60601 series	Basic safety and essential performance of medical electrical equipment	Electromechanical device submissions
ISO 11135	Validation of ethylene oxide sterilization	Sterilization validation for EO-sterilized devices (sterilization validation guide →)
ISO 11137	Validation of radiation sterilization	Sterilization validation for radiation-sterilized devices (sterilization validation guide →)
ISO 11607	Packaging for terminally sterilized medical devices	Sterile barrier system validation ahead of a 510(k) or PMA (packaging design & validation →)
ISO 15223-1	Symbols for use in medical device labeling	Labeling review
ISO 14155	Good clinical practice for clinical investigation of medical devices	IDE and clinical study design

ISO 13485 Key Requirements

ISO 13485:2016 sets its requirements in five clauses, 4 through 8:

• Quality management system (clause 4). A documented quality system, including a quality manual, a medical device file for each device type or family, and control of documents and records.
• Management responsibility (clause 5). A documented quality policy, defined responsibilities and authorities, and regular management review of the quality system's performance.
• Resource management (clause 6). Competent, trained personnel and a controlled work environment appropriate to the product.
• Product realization (clause 7). Design and development controls, purchasing controls over suppliers, production and process controls, and identification and traceability through the product lifecycle.
• Measurement, analysis and improvement (clause 8). Internal audits, monitoring of customer feedback and complaints, control of nonconforming product, and corrective and preventive action (CAPA).

The standard applies a risk based approach throughout and requires risk management during product realization. ISO 14971 is the standard normally used to meet that requirement. See the full ISO 13485 implementation guide for how these requirements translate into an actual quality manual and procedure set.

How FDA Recognizes Consensus Standards

FDA maintains a recognized consensus standards database for medical devices: a searchable list, by standards organization, standard number, and FDA specialty task group area (including a dedicated Biocompatibility area), of the standards FDA will accept a Declaration of Conformity against in a premarket submission. Recognition is standard-by-standard and edition-specific: FDA recognizes a particular edition of a standard, not the standard in the abstract, and the recognized edition can change over time as standards are revised. A manufacturer citing a standard in a submission should confirm the currently recognized edition directly in FDA's database rather than assume it from the standard's own publication date.

Frequently Asked Questions

What are the ISO standards for medical devices?

There is no single ISO standard that covers all medical devices. Instead, a set of standards each cover a different part of the product and quality system, the most common being ISO 13485 for quality management, ISO 14971 for risk management, the ISO 10993 series for biocompatibility, IEC 62304 for software, IEC 62366-1 for usability, and ISO 11135/11137/11607 for sterilization and packaging.

What are the key requirements of ISO 13485?

ISO 13485:2016 requires a documented quality management system covering quality system documentation, management responsibility, resource management, product realization (including design controls and purchasing controls), and measurement, analysis, and improvement (including CAPA and complaint handling), with risk management applied throughout the product lifecycle.

How does FDA recognize consensus standards like these?

FDA maintains a recognized consensus standards database that lists the specific standards, by edition, to which FDA will accept a manufacturer's Declaration of Conformity in a premarket submission. Recognition is standard-by-standard and edition-specific, so a manufacturer should confirm the current recognized edition in FDA's database rather than assume it from the standard's publication date.

Is ISO 13485 certification the same as FDA QMSR compliance?

No, though the two are closely aligned. ISO 13485:2016 is a voluntary, third-party-certifiable standard; the FDA Quality Management System Regulation (QMSR, 21 CFR Part 820) incorporates ISO 13485:2016 by reference but is a binding US regulation enforced through FDA inspection, with some additional FDA-specific record requirements layered on top.