Standards
The Standards Auditors Check Against
35 standards that come up in medical device audits, grouped by subject. Each guide explains what the standard covers, who it applies to and what auditors look for in your records, in plain language and without reproducing the standard's text.
Quality Systems
| Designation | Subject | Scope in Brief |
|---|---|---|
| ISO 13485 | Quality Management Systems for Medical Devices | The QMS standard for medical device organizations, now incorporated by reference into FDA's QMSR. |
| ISO 16142-1 | Essential Principles of Safety and Performance | Recognized essential principles of safety and performance for non-IVD devices, with guidance on choosing standards. |
Risk Management
| Designation | Subject | Scope in Brief |
|---|---|---|
| ISO 14971 | Risk Management for Medical Devices | The risk management process for medical devices, from hazard identification through production and post-production. |
| ISO/TR 24971 | Guidance on Applying Medical Device Risk Management | A technical report with practical guidance on applying ISO 14971. It explains methods and adds no requirements. |
Biocompatibility and Materials
| Designation | Subject | Scope in Brief |
|---|---|---|
| ISO 10993 Series | Biological Evaluation of Medical Devices | A family of standards for evaluating the biological safety of devices and materials that contact the body. |
| ISO 10993-1 | Biological Evaluation Within a Risk Management Process | The framework part of ISO 10993: how to plan a biological evaluation from body contact and risk. |
Sterilization, Cleanrooms and Packaging
| Designation | Subject | Scope in Brief |
|---|---|---|
| ISO 11135 | Ethylene Oxide Sterilization | Development, validation and routine control of ethylene oxide sterilization for medical devices. |
| ISO 11137 | Radiation Sterilization | A multi-part standard for sterilizing health care products with gamma, electron beam or X-ray radiation. |
| ISO 17665 | Moist Heat Sterilization | Development, validation and routine control of moist heat (steam) sterilization for health care products. |
| ISO 11737 | Microbiological Methods for Sterilization | Methods for determining bioburden and for tests of sterility used to define and validate sterilization processes. |
| ISO 13408 | Aseptic Processing of Health Care Products | A multi-part standard for aseptic processing when products can't be sterilized in their final container. |
| ISO 14644 | Cleanrooms and Controlled Environments | Classification, monitoring and operation of cleanrooms based on airborne particle concentration. |
| ISO 11607 | Packaging for Terminally Sterilized Medical Devices | Requirements for sterile barrier and packaging systems, and validation of forming, sealing and assembly. |
Electrical Safety, EMC, Usability and Connectors
| Designation | Subject | Scope in Brief |
|---|---|---|
| IEC 60601-1 | Basic Safety and Essential Performance of Medical Electrical Equipment | The general safety standard for medical electrical equipment, covering basic safety, essential performance and the risk management behind both. |
| IEC 60601-1-2 | Electromagnetic Compatibility of Medical Electrical Equipment | The collateral standard for EMC: how much electromagnetic disturbance equipment emits and how well it keeps working when exposed to it. |
| IEC 60601-1-6 | Usability of Medical Electrical Equipment | The usability collateral to IEC 60601-1, which points medical electrical equipment makers to the IEC 62366-1 process. |
| IEC 60601-1-8 | Alarm Systems in Medical Electrical Equipment | Requirements for alarm systems in medical electrical equipment and systems: priorities, signals, settings and logging. |
| IEC 60601-1-11 | Medical Electrical Equipment in the Home Healthcare Environment | Requirements for medical electrical equipment used at home and in other places outside professional healthcare facilities. |
| ISO 80369 Series | Small-Bore Connectors for Liquids and Gases in Healthcare | A multi-part series of small-bore connector designs that keeps connectors for one clinical application from fitting another. |
| IEC 62366-1 | Usability Engineering for Medical Devices | The process for analyzing, specifying, designing and evaluating a device's user interface so use-related risk is understood and controlled. |
Software, Cybersecurity and AI
| Designation | Subject | Scope in Brief |
|---|---|---|
| IEC 62304 | Medical Device Software Lifecycle Processes | The lifecycle process standard for medical device software, scaled by a software safety classification of A, B or C. |
| IEC 82304-1 | Safety of Health Software Products | Product-level safety and security requirements for health software that runs on general computing platforms without dedicated hardware. |
| IEC 81001-5-1 | Security Activities in the Health Software Lifecycle | Cybersecurity activities built into the health software lifecycle, from security requirements and threat modeling through vulnerability handling. |
| ISO/IEC 27001 | Information Security Management Systems | The management system standard for information security, which hospital and enterprise customers often ask device makers about. |
| ISO/IEC 42001 | Artificial Intelligence Management Systems | A management system standard for organizations that develop, provide or use AI, covering governance, risk and impact assessment. |
Labeling and Symbols
| Designation | Subject | Scope in Brief |
|---|---|---|
| ISO 15223-1 | Symbols for Medical Device Labeling | Standardized symbols for information supplied with medical devices, from use-by date to sterilization method. |
| ISO 20417 | Information Supplied by the Manufacturer | General requirements for the labels, instructions for use and other information supplied with medical devices. |
Clinical Investigations
| Designation | Subject | Scope in Brief |
|---|---|---|
| ISO 14155 | Clinical Investigation of Medical Devices in Human Subjects | Good clinical practice for designing, conducting, recording and reporting medical device clinical investigations. |
IVD and Laboratories
| Designation | Subject | Scope in Brief |
|---|---|---|
| ISO 18113 | Labeling and Instructions for IVD Medical Devices | A multi-part standard for the information IVD manufacturers supply with reagents and instruments, for professional use and self-testing. |
| ISO 20916 | Clinical Performance Studies for IVD Medical Devices | Good study practice for IVD clinical performance studies that use specimens from human subjects. |
| ISO 23640 | Stability Evaluation of IVD Reagents | How IVD manufacturers design and run studies that support shelf life, in-use and transport stability claims for reagents. |
| ISO 15189 | Quality and Competence of Medical Laboratories | Requirements for quality and competence in medical laboratories, used as the basis for laboratory accreditation. |
| ISO/IEC 17025 | Competence of Testing and Calibration Laboratories | Requirements for the competence, impartiality and consistent operation of testing and calibration laboratories. |
Auditing and Management Systems
| Designation | Subject | Scope in Brief |
|---|---|---|
| ISO 9001 | General Quality Management Systems | The general-purpose QMS standard used across industries, and why device regulators look for ISO 13485 instead. |
| ISO 19011 | Guidelines for Auditing Management Systems | Guidance on audit principles, managing an audit program, conducting audits and evaluating auditor competence. |
These pages summarize scope for orientation. They are not the standards themselves, which are copyrighted and sold by ISO, IEC and national standards bodies. Check which edition your market, notified body or certification body expects before you rely on any of them.
Next Step
Find Out Which Standards Apply to You
Which standards matter depends on your device, its materials, its software and its markets. An advisor will map that out as part of an assessment. Please don't send confidential documents yet: secure upload is set up after onboarding.
