Overview
IEC TR 60788:2004 - Medical electrical equipment – Glossary of defined terms is a Technical Report published by the International Electrotechnical Commission (IEC) that collates and harmonizes all defined terms used across IEC standards and technical reports within the scope of medical electrical equipment (IEC TC 62) as of May 2003. The report is a mirror of terminology from applicable General, Particular and Collateral standards and is designed to support consistent language, translation and electronic searchability for standards dealing with medical devices and radiological equipment.
Key topics and requirements
- Comprehensive glossary: Mirrors all defined terms used in IEC publications under the medical electrical equipment scope; includes terms from radiology and ionizing radiation (rm-xx-xx) chapters.
- Search features: Structured to ease electronic use with two search modes - alphabetic index and search by technical/physical chapters (notably for ionizing radiation).
- Harmonization guidance: Recommendations (highlighted in the original table) to reduce redundancy and encourage consistent use of definitions across standards.
- Coded references: Where applicable, entries include reference codes from the International Electrotechnical Vocabulary (IEV) and retained “rm-xx-xx” codes for radiology terms.
- Maintenance process: Annual editorial maintenance cycle managed by IEC TC 62 and subcommittees; compilation of additions/deletions performed by the committee secretary to keep definitions current.
- Targets and purpose: Reflect state-of-the-art terminology, harmonize language across IEC publications, ease translations, and enable self-review by experts working on medical electrical equipment standards.
Practical applications and users
IEC TR 60788 is a practical resource for:
- Standards developers and technical committees ensuring consistent term usage across IEC medical device standards.
- Medical device manufacturers and design engineers referencing precise terminology for product specifications and compliance.
- Regulatory and conformity assessment bodies that review documentation and declarations of conformity.
- Test laboratories and quality assurance teams performing evaluation against IEC standards (e.g., IEC 60601 series).
- Technical writers and translators working on international standards and regulatory submissions.
- Clinical engineers and procurement specialists who need unambiguous definitions when assessing equipment requirements.
Related standards
- Mirrors defined terms from multiple IEC standards relevant to medical electrical equipment (for example, the IEC 60601 family listed in the report).
- References and alignment with terminology in broader documents such as ISO/IEC vocabularies and risk-management standards cited in the report (e.g., ISO 14971 appears in the mirrored list).
IEC TR 60788 is therefore an essential reference for consistent, searchable terminology in the ecosystem of medical electrical equipment standards, improving clarity, regulatory compliance and international harmonization.