Competency information
Details
Identify and navigate the standards that underpin or are used within the organisation’s medical device management strategy and associated service delivery
Considerations
- Existence of and ability to navigate key prevailing standards, including:
- legal requirements, health and safety at work legislation
- medical device elements of prevailing NHS standards, eg Care Quality Commission and NHS Litigation Authority
- electromedical safety standards, IEC60601, part one, collaterals and family of particular part 2 standards
- ISO 9001 quality management standards risk management standards
- best practice standards
- The philosophy, hierarchy of IEC 60601 and key differences from other standards, ie single fault condition Understand how these standards are used by the practising clinical engineer.
- The clinical governance framework and corporate objectives of the organisation.
- Local healthcare environment and range of services offered by the institution and the existence of relevant policies and procedures.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 5 | Outcome design of training material to support the use of a medical device in the clinical setting |