Competency information
Details
Navigate and interpret the IEC 60601 electromedical family of standards, including collateral, particular and performance standards
Considerations
- Content and structure of IEC 60601 family of standards:
- Part 1 General standard
- Part 1 Collateral standards
- Part 2 Particular standard
- Part 3 Performance standard
- The horizontal nature of part 1 and collaterals, contrasted with the specific nature of particular standards
- An appreciation of the typical engineering content
- The standards development process and crucial role of the healthcare scientist in acting as the patient’s ambassador in developing standards
- How the standards are used by different parties, eg the manufacturer, the regulators and the healthcare scientist
- The existence of alternative publications where a standard is not appropriate, eg a rapidly changing technology leading to a technical report or publically available specification
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 2 | Outcome Interpret and recommend application of relevant national standards relating to medical device management and assessment of risks |