BS EN 62353 is the international Standard that applies to testing of medical electrical equipment and medical electrical systems (referred to as ME equipment and ME systems).
It is applicable to equipment or systems that comply with IEC 60601-1, before putting into service, during maintenance, inspection, servicing and after repair, or on occasion of recurrent tests, to assess their safety.
For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment.
This standard contains:
- "General requirements", that contain clauses of general concern
- "Particular requirements", further clauses handling special types of ME equipment or ME systems and applying in connection with the "General requirements".
BS EN 62353 is not suitable to assess whether ME equipment or ME systems or any other equipment comply with the relevant standards for their design.
This standard does not define requirements for repair, exchange of components and modification of ME equipment or ME systems.
All maintentance, inspection, servicing and repair done in accordance with the manufacturer’s instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements has to be assessed and verified.
This standard is also applicable to tests after repair. The testing shall be defined according to the extent of work performed and applicable guidance from the manufacturer.
This standard is not intended to define time intervals for recurrent tests. If such intervals are not defined by the manufacturer, then this standard may be used to help establish those intervals.
Contents of BS EN 62353 contains:
- Scope
- Normative references
- Terms and definitions
- Requirements
- Testing before putting into service, after modifications, and after repair
- Recurrent test
- Tests
- Visual inspection
- Measurements
- Functional test
- Results of test and evaluation
- Reporting of results
- Evaluation
- General guidance and rationale
- Sequence of testing
- Requirements for the measurement equipment and for measurement circuits for protective earth resistance and leakage currents
- Patient environment
- Allowable values for leakage currents from IEC 60601-1
- Testing intervals
- Example of test documentation
- Bibliography
- Index of defined terms