YY/T 0841-2011
Medical electrical equipment.Recurrent test and test after repair of medical electrical equipment (English Version)
- Standard No.
- YY/T 0841-2011
- Language
- Chinese, Available in English version
- Release Date
- 2011
- Published By
- Professional Standard - Medicine
- Status
- 2025-09
- Replace By
- YY/T 0841-2023
- Latest
- YY/T 0841-2023
- Scope
- This standard applies to medical electrical equipment (hereinafter referred to as ME equipment), medical electrical systems (hereinafter referred to as ME system) and their components that comply with IEC 60601-1 before delivery, during maintenance, inspection, after-sales service and after repair. testing, or in some cases periodic testing, to assess their safety. If the equipment is not designed in accordance with IEC 60601-1, the requirements in this standard may also be used by referring to the safety standards at the time of design and the information in the instructions for use. This Standard contains tables listing permissible values for different versions of IEC 60601-1. For the purposes of this Standard, the measurement methods used are independent of which version of the standard the ME EQUIPMENT or ME SYSTEM has been designed to comply with. This Standard contains the following parts: ——"General Requirements", containing clauses under general considerations, and - "Specific Requirements", i.e. more clauses specific to particular types of ME EQUIPMENT or ME SYSTEMS. These Terms are used in conjunction with the General Requirements. This Standard does not apply to the assessment of whether the design of ME EQUIPMENT, ME SYSTEM or some other equipment complies with their relevant standards. This standard defines requirements for the following activities: repair, exchange of parts and modification of ME EQUIPMENT or ME SYSTEM. This standard also applies to post-repair testing. Testing shall be as defined by the scope of the repair work and the appropriate guidance document provided by the manufacturer. This standard is not intended to define the intervals between periodic tests. If the manufacturer does not specify such an interval, Appendix F can help determine such an interval.
YY/T 0841-2011 Referenced Document
- GB 16895.24 Electrical installations of buildings.Part 7-710:Requirements for special installations or locations.Medical locations
- GB 4793.1 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements
- GB 4793.5 Safety requirements for electrical equipment for measurement, control, and laboratory use.Part 5: Safety requirements for hand-held probe assemblies for electrical measurement and test
- GB 4793.6 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 6: Particular requirements for laboratory material heating equipment
- GB/T 17045 Protection against electric shock—Common aspects for installations and equipment*， 2020-03-31 Update
- GB/T 18216.1 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c.—Equipment for testing, measuring or monitoring of protective measures—Part 1: General requirements*， 2021-05-21 Update
- GB/T 5465.2 Graphical symbols for electrical equipment Part 2: Graphical symbols*， 2023-12-28 Update
YY/T 0841-2011 history
- 2023 YY/T 0841-2023 Medical electrical equipment Periodic testing and post-repair testing of medical electrical equipment
- 2011 YY/T 0841-2011 Medical electrical equipment.Recurrent test and test after repair of medical electrical equipment
