Overview - ISO/IEC Guide 63:2019 (Guide to safety in medical device standards)
ISO/IEC Guide 63:2019 provides requirements and recommendations to writers of International Standards on how to include aspects of safety for medical devices. Published as the third edition in 2019, the Guide is built on established risk management concepts and ISO/IEC Guide 51:2014. It applies to safety of people, property and the environment, and treats “product” broadly to include a single medical device or a system of medical and non‑medical devices.
Key topics and technical requirements
The standard focuses on practical, risk‑based inclusion of safety aspects in standards development:
- Terms and definitions: harmonized definitions for harm, hazard, hazardous situation, intended use, life cycle, manufacturer, etc.
- Use of terms: guidance on using “safety”, “safe”, “effective”, and “effectiveness” consistently.
- Principles for safety inclusion: scope, objectives, and coordination of medical device standards (product, process, installation/environment, in‑service).
- Nature of risk: elements of risk; systematic vs random causes; how hazards lead to hazardous situations and harm.
- Risk‑based process for standards development: preparatory work (need identification, risk management framework, acceptability criteria), iterative drafting, hazard identification, risk estimation and evaluation, selection of risk controls, verification of control effectiveness, assessment of residual risks, and validation of the standard.
- Life‑cycle approach: addresses risk across design, production, distribution, installation, use, service, maintenance, and disposal.
- Regulatory implications and coordination: considerations when standards are used in conformity assessment or regulation.
Practical applications - who uses this Guide
ISO/IEC Guide 63:2019 is intended for:
- Standards writers and technical committees developing medical device standards
- Manufacturers who align product development and technical documentation with harmonized safety requirements
- Regulators and conformity assessment bodies using standards as part of regulatory frameworks
- Healthcare providers and procurement teams seeking clarity on safety expectations for devices and systems
- Test laboratories and certification bodies implementing verification and validation steps defined in standards
Practical uses include drafting standards that integrate risk management, harmonizing safety language across device families, and ensuring standards consider intended use, reasonably foreseeable misuse, and residual risk.
Related standards
- ISO/IEC Guide 51:2014 (general safety principles)
- GHTF guidance documents referenced in the Guide
- Often used alongside medical device risk management practices (for example, ISO 14971) when developing or applying standards.
For implementation, obtain the full document from ISO or your national standards body.