YY 0671.1-2009: Translated English of Chinese Standard. YY0671.1-2009: Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices

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https://www.chinesestandard.net, 2. aug. 2017 - 38 sider
This Part of YY 0671 is a special standard based on GB 9706.1-2007 Medical electrical equipment - Part 1: General requirements for safety. GB 9706.1-2007 is referred to herein as a general standard. A general standard is the basic standard for the safety of medical electrical equipment used or monitored by qualified personnel in general medical and patient environments. It also includes some requirements for reliable operation to ensure safety.

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Innhold

Foreword
6
Introduction
8
Scope
9
Terms and definitions
10
General requirements
13
Input power
17
Not used
18
Isolation
19
Optical radiation including laser
22
Requirements and tests for AP device and its components and elements
23
Overflow liquid spill leak moisture liquid injection cleaning disinfection sterilization and compatibility
24
Biocompatibility
25
Abnormal operation and fault status
26
Shell and enclosure
27
Network power parts components and wiring
30
Annex A Informative Basic principles
31

Face corner and side
20
Pneumatic and hydraulic power
21
Annex B Informative Glossary
37

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Om forfatteren (2017)

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