YY 0671.1-2009 (YY0671.1-2009)

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YY 0671.1-2009
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
Sleep apnoea breathing therapy –
Part 1. Sleep apnoea breathing therapy devices
(ISO 17510-1.2002, MOD)
ISSUED ON. JUNE 16, 2009
IMPLEMENTED ON. DECEMBER 1, 2010
Issued by. China Food and Drug Administration
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Table of Contents
Foreword ... 6 
Introduction ... 8 
1 Scope* ... 9 
2 Terms and definitions ... 10 
3 General requirements ... 13 
4 Test general requirements ... 13 
5 Classification ... 13 
6 Identification, marks and files ... 13 
7 Input power ... 17 
8 Basic safety type ... 17 
9 Removable protective device ... 17 
10 Ambient conditions ... 17 
11 Not used ... 18 
12 Not used... 18 
13 Overview ... 18 
14 Requirements for classification ... 18 
15 Voltage and/or energy limits ... 18 
16 Shell and enclosure ... 18 
17 Isolation ... 19 
18 Protection earthing, functional grounding and potential equalization ... 19 
19 Continuous leakage current and patient auxiliary current ... 19 
20 Dielectric strength ... 19 
21 Mechanical strength ... 19 
22 Moving parts ... 19 
23 Face, corner and side ... 20 
24 Certainty during normal use ... 20 
25 Splash ... 20 
26 Vibration and noise ... 20 
27 Pneumatic and hydraulic power ... 21 
28 Suspension ... 21 
29 X-ray radiation ... 21 
30 Α, β, λ neutron radiation and other particle radiation ... 21 
31 Microwave radiation ... 21 
32 Optical radiation (including laser) ... 22 
33 Infrared radiation ... 22 
34 Ultraviolet radiation ... 22 
35 Sound energy (including ultrasound) ... 22 
36 Electromagnetic compatibility ... 22 
37 Location and basic requirements ... 22 
38 Signs, random files ... 22 
39 Common requirements for AP and APG devices ... 22 
40 Requirements and tests for AP device and its components and elements 23 
41 Requirements and tests for APG device and its components and elements
... 23 
42 Over-temperature ... 23 
43* Fire protection ... 23 
44 Overflow, liquid spill, leak, moisture, liquid injection, cleaning, disinfection,
sterilization and compatibility ... 24 
45 Pressure vessel and pressured parts ... 24 
46 Not used... 24 
47 Static charge ... 24 
48 Biocompatibility ... 25 
49 Power supply interruption... 25 
50 Accuracy of work data ... 25 
51 Hazardous output prevention ... 25 
52 Abnormal operation and fault status ... 26 
53 Ambient test ... 26 
54 Overview ... 26 
55 Shell and enclosure ... 27 
56 Components and elements ... 27 
57 Network power parts, components and wiring ... 30 
58 Protective ground - terminals and connections ... 30 
59 Structure and wiring ... 30 
Annex ... 30 
Annex A (Informative) Basic principles ... 31 
Annex B (Informative) Glossary ... 37 
Bibliography ... 38 
Foreword
YY 0671 Sleep apnoea breathing therapy consists of the following parts.
-- Part 1. Sleep apnoea breathing therapy devices;
-- Part 2. Masks and application accessories.
This Part is the first part of YY 0671.
The modification of this Part uses the International Standard ISO
17510-1.2002 Sleep apnoea breathing therapy -- Part 1. Sleep apnoea
breathing therapy devices.
The main difference between this Part and ISO 17510-1.2002 is as follows.
This Part modified Clause 2 “Normative references” of ISO 17510-1.2002 to
sub-clause 1.101, Clause 3 “Terms and definitions” to Clause 2, so as to be
consistent with the common standard number.
This Part is a special standard based on GB 9706.1-2007 Medical electrical
equipment - Part 1. General requirements for safety (a general standard). It
shall be used together with GB 9706.1-2007.
Clause 36 Electromagnetic compatibility of this Part shall be implemented
concurrently with YY 0505-2005 (IEC 60601-1-2.2001, IDT) Medical electrical
equipment - Part 1-2. General requirements for safety - Collateral standards.
Electromagnetic compatibility - Requirements and tests.
Clause 56 of this Part referred to EN 556 Sterilization of medical devices.
Requirements for medical devices to be designated "STERILE", PrEN
737-6.1998 Medical gas pipeline systems - Part 6. Dimensions of probes for
terminal units for compressed medical gases and vacuum, EN 739
Low-pressure hose assemblies for use with medical gases, EN ISO 8185
Humidifiers for medical use - General requirements for humidification
systems, EN ISO 9360-1 Anaesthetic and respiratory equipment -- Heat and
moisture exchangers (HMEs) for humidifying respired gases in humans --
Part 1. HMEs for use with minimum tidal volumes of 250 ml. It shall be
implemented concurrently with these standards after they are converted to
national or industry standards. It shall be explained in the preparation
instructions.
Annex AA and Annex BB of this Part are informative.
This Part was proposed by a...