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YY 0671.1-2009Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices (English PDF)

睡眠呼吸暂停治疗第1部分：睡眠呼吸暂停治疗设备

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

June 16, 2009

Implementation date

December 1, 2010

Scope

YY 0671.1-2009 is the English-translated version of 睡眠呼吸暂停治疗第1部分：睡眠呼吸暂停治疗设备.

YY 0671.1-2009 is the Chinese standard "Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices".

Its scope clause reads: The scope given in Clause 1 of GB 9706.1-2007 is applicable but it made the following additions: this Part of YY 0671 specifies the specific requirements for sleep apnoea breathing therapy for the home and health care department; this Part of YY 0671 is not applicable to a variety of equipment involved in GB 9706.28; this Part of YY 0671 does not consider high-frequency jet ventilator, high-frequency oscillation ventilator; Part 2 of YY 0671 sets out requirements for masks and application accessories; this Part of YY 0671 is not applicable to vitro breathing apparatus described in GB/T 4999-2003. Its clauses include scope*; terms and definitions.

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Document preview — YY 0671.1-2009

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Foreword6
Introduction8
1 Scope*9
2 Terms and definitions10
3 General requirements13
4 Test general requirements13
5 Classification13
6 Identification, marks and files13
7 Input power17
8 Basic safety type17
9 Removable protective device17
10 Ambient conditions17
11 Not used18
12 Not used18
13 Overview18
14 Requirements for classification18
15 Voltage and/or energy limits18
16 Shell and enclosure18
17 Isolation19
18 Protection earthing, functional grounding and potential equalization19
19 Continuous leakage current and patient auxiliary current19
20 Dielectric strength19
21 Mechanical strength19
22 Moving parts19
23 Face, corner and side20
24 Certainty during normal use20
25 Splash20
26 Vibration and noise20
27 Pneumatic and hydraulic power21
28 Suspension21
29 X-ray radiation21
30 alpha, beta, lambda neutron radiation and other particle radiation21
31 Microwave radiation21
32 Optical radiation (including laser)22
33 Infrared radiation22
34 Ultraviolet radiation22
35 Sound energy (including ultrasound)22
36 Electromagnetic compatibility22
37 Location and basic requirements22
38 Signs, random files22
39 Common requirements for AP and APG devices22
42 Over-temperature23
43* Fire protection23
sterilization and compatibility24
45 Pressure vessel and pressured parts24
46 Not used24
47 Static charge24
48 Biocompatibility25
49 Power supply interruption25
50 Accuracy of work data25
51 Hazardous output prevention25
52 Abnormal operation and fault status26
53 Ambient test26
54 Overview26
55 Shell and enclosure27
56 Components and elements27
57 Network power parts, components and wiring30
58 Protective ground - terminals and connections30
59 Structure and wiring30
Annex30
Annex A (Informative) Basic principles31
Annex B (Informative) Glossary37
Bibliography38

1 Scope*

The scope given in Clause 1 of GB 9706.1-2007 is applicable but it made the following additions:

this Part of YY 0671 specifies the specific requirements for sleep apnoea breathing therapy for the home and health care department;

this Part of YY 0671 is not applicable to a variety of equipment involved in

GB 9706.28;

this Part of YY 0671 does not consider high-frequency jet ventilator, high-frequency oscillation ventilator;

Part 2 of YY 0671 sets out requirements for masks and application accessories;

this Part of YY 0671 is not applicable to vitro breathing apparatus described in GB/T 4999-2003.

1.101 Normative references

The provisions in following documents become the provisions of this Part of

YY 0671 through reference in this Part. For dated references, the subsequent amendments (excluding corrigendum) or revisions do not apply to this Part, however, parties who reach an agreement based on this Part are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies.

GB/T 3767-1996, Acoustics - Determination of Sound Power Levels of Noise

Sources Using Sound Pressure - Engineering Method in an Essentially Free

Field over a Reflecting Plane (eqv ISO 3744-94)

GB/T 3785-1983, Electric, sonic properties and measuring methods for sound level meters

GB/T 4999-2003, Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001, IDT)

GB/T 5332-2007, Method of test for ignition temperature of flammable liquids and gases (IEC 60079-4:1975, IDT)

GB 7144-1999, Coloured cylinder mark for gases

GB 9706.1-2007, Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988, IDT)

GB 18278-2000, Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization (idt ISO 11134:1994)

GB 18279-2000, Medical devices--Validation and routine control of ethylene oxide sterilization (idt ISO 11135:1994)

GB 18280-2000, Sterilization of health care products - Requirement for validation and routine control - Radiation sterilization (idt ISO 11137:1995)

YY 1040.1-2003, Anaesthetic and respiratory equipment - Conical connectors

- Part 1: Cones and sockets (ISO 5356-1:1996)

YY 1040.2-2008, Anaesthetic and respiratory equipment - Conical connectors

- Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006, IDT)

YY 0505-2005, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standards: Electromagnetic compatibility -

Requirements and tests (IEC 60601-1-2:2001, IDT)

YY 0466-2003, Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied (ISO 15223:2000, IDT)

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, Respiratory tract humidifiers for medical use -- Particular requirements for respiratory 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

2 Terms and definitions

For the purposes of this document, the terms and definitions defined in GB […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Cited by

YY 0671.2-2011Sleep apnoea breathing therapy - Part 2: Masks and application accessories

Similar standards

YY 0671-2021|YY 9706.270-2021|YY 0671.2-2011

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