YY/T 0456.1-2003
Replaced
YY/T 1837-2022
Active
Industry standards-Medicine
YY/T 1837-2022 Medical electrical equipment—General requirements for reliability
YY/T 1837-2022 Medical electrical equipment—General requirements for reliability
Price:
$ 70.00
Basic Information
Standard Code:
YY/T 1837-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Laboratory medicine
Publish Date:
2022-05-18
Implement Date:
2023-06-01
Pages:
64 pages
Scope
This document specifies the general requirements and basic methods for conducting reliability work during the life cycle of medical electrical equipment (hereinafter referred to as ME equipment) and medical electrical systems (hereinafter referred to as ME systems).
This document applies to reliability work for all types of ME equipment or ME systems. This document does not include specific requirements and methods for software reliability.
Note: All chapters and articles in the main text of this document have corresponding explanations of the relevant principles in Appendix A.
Development Information
Referenced Standards
GB/T 2900.1-2008 Electrotechnical terminology—Fundamental terms
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
YY/T 1813-2022 Methods for operational reliability information collection and evaluation of medical electrical equipment
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YY/T 0456.2-2003
Replaced
YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin
YY/T 0456.3-2003
Replaced
YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent
YY/T 0475-2004
Replaced
YY/T 0475-2004 General technical requirements for urine analyzer
YY/T 0478-2004
Replaced
YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis
YY/T 0032-2004
Active