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YY 9706.108-2021 English PDF

YY 9706.108-2021 English PDF

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YY 9706.108-2021: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance-Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

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Scope

The object of this Part is to specify BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements and tests for ALARM SYSTEMS in ME EQUIPMENT and ME SYSTEMS and
to provide guidance for their application.
A requirement in a particular standard takes priority over the corresponding requirement in this
Part.

Basic Data

Standard ID YY 9706.108-2021 (YY9706.108-2021)
Description (Translated English) Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance-Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C30
Word Count Estimation 66,627
Issuing agency(ies) State Drug Administration


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