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YY 0600.1-2007Lung ventilators for medical use -- Particular requirements for basic safety and essential performance - - Part 1: Home-care ventilatory support devices (English PDF)

医用呼吸机基本安全和主要性能专用要求第1部分：家用呼吸支持设备

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

January 31, 2007

Implementation date

February 1, 2008

Scope

YY 0600.1-2007 is the English-translated version of 医用呼吸机基本安全和主要性能专用要求第1部分：家用呼吸支持设备.

YY 0600.1-2007 is the Chinese pharmaceutical industry standard that sets the basic safety and essential performance requirements for home-care ventilatory support devices, the ventilators intended mainly for use at home but which may also be used elsewhere, in a healthcare facility for instance, for patients who do not need a home care ventilator complying with YY 0600.2.

It is the first part of the YY 0600 series and applies together with GB 9706.1-2007, whose clauses it replaces or modifies, covering the delivered ventilation and its accuracy, the alarms, the behaviour on failure of the power supply and the information supplied with the device. Issued on 31 January 2007, it has applied since 1 February 2008.

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Document preview — YY 0600.1-2007

National Standard of the People's Republic of China

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

Foreword5
Introduction7
1 Scope9
2 Terms and definitions10
3 General requirements12
4 General requirements for tests13
5 Classification13
6 Identification, marking and documents13
7 Power input19
8 Basic safety categories19
9 Removable protective means19
10 Environmental conditions19
11 Not used20
12 Not used20
13 General20
14 Requirements related to classification20
15 Limitation of voltage and/or energy21
16 Enclosures and protective covers21
17 Separation21
18 Protective earthing, functional earthing and potential equalization21
19 Continuous leakage currents and patient auxiliary currents21
20 Dielectric strength21
21 Mechanical strength22
22 Moving parts22
23 Surfaces, corners and edges22
24 Stability in normal use22
25 Expelled parts22
26 Vibration and noise22
27 Pneumatic and hydraulic power22
28 Suspended masses22
29 X-ray radiation22
30 alpha, beta, gamma, neutron radiation and other particle radiation23
31 Microwave radiation23
32 Light radiation (including lasers)23
33 Infra-red radiation23
34 Ultra-violet radiation23
35 Acoustical energy (including ultrasonic)23
36 Electromagnetic compatibility23
37 Locations and basic requirements24
38 Marking, accompanying documents24
39 Common requirements for category AP and category APG equipment24
40 Requirements and tests for category AP equipment, parts and components thereof24
41 Requirements and tests for category APG equipment, parts and components thereof24
42 Excessive temperature24
43 Fire prevention24
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility25
45 Pressure vessels and parts subject to pressure27
46 Human errors27
47 Electrostatic charges27
48 Biocompatibility27
49 Interruption of the power supply27
50 Accuracy of the operating data28
51 Protection against hazardous output28
52 Abnormal operation and fault conditions30
53 Environmental tests31
54 General31
55 Enclosures and covers31
56 Components and general assembly31
57 Mains parts, components and layout34
58 Protective earthing - Terminals and connections34
59 Construction and layout34
101 Alarm systems34
102 Appendix of general standard34
Appendix AA (Informative) Rationale36
References42

Foreword

YY 0600 "Lung ventilators for medical use - Particular requirements for basic safety and essential performance" consists of the following components:

- Part 1: Home-care ventilatory support devices;

- Part 2: Home care ventilators for ventilator-dependent patients;

- Part 3: Emergency and transport ventilators. The following parts of YY 0600 are under preparation:

- Part 4: Operator-powered resuscitators;

- Part 5: Gas-powered emergency resuscitators.

This part is part 1 of YY 0600, which modifies and adopts the international standard ISO 10651-6:2004 "Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support device" (English version). The main differences between this part and ISO 10651-6:2004 are as follows:

- In this part, adjust the clause 2 "Normative references" of ISO 10651-6:2004 into 1.101; adjust the clause 3 "Terms and definitions" into clause 2, in order to keep consistency with the number of general standard;

- In clause 46, it is modified into "do not adopt";

- In 56.3 bb), modify the connector of the high-pressure input port to comply with the provisions of Table 2 and Figure 3 of ISO 5359;

- DELETE the Appendix BB;

- The unit "hPa" in this part is converted to "kPa".

This part is a particular standard based on GB 9706.1-2007 (IEC 60601-1:1988 + Amd1:1991 + Amd2:1995, IDT) "Medical electrical equipment - Part 1: General requirements for safety", which is used in conjunction with GB 9706.1 AND implemented at the same time with GB 9706.1-2007 (IEC 60601-1:1988 + Amd1:1991 + Amd2:1995, IDT).

The clause 36 of this part is implemented at the same time with YY 0505-2005 "Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standards: Electromagnetic compatibility - Requirements and tests".

1 Scope

GB 9706.1-2007, clause 1 applies, except as follows. Modification:

This part of YY 0600 specifies the basic safety and essential performance requirements for home-care ventilator support devices, intended mainly for use in home care BUT which could be used elsewhere (e.g. in healthcare facilities) for appropriate patients for whom the use of a home-care ventilator complying with YY 0600.2 is not required.

The requirements of this part of YY 0600 which replace or modify the requirements of the general standards are intended to take precedence over the corresponding general requirements.

1.101 Normative references

The provisions in following documents become the provisions of this part through reference in this part of YY 0600. For the dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard; however, parties who reach an agreement based on this Standard 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 4999-2003 Anesthetic and respiratory equipment - Vocabulary (ISO 4135:2001, IDT)

GB/T 5332-1985 Method of test for ignition temperature of flammable liquids and gases (eqv IEC 60079-4:1975)

GB 7144-1999 Coloured cylinder mark for gases

GB 9706.1 Medical electrical equipment - Part 1: General requirements for safety (GB 9706.1-2007, IEC 60601-1:1988 + Amd1:1991 + Amd2:1995, IDT)

GB/T 19974-2005 Sterilization of health care products - General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process (ISO 14937:2000, IDT)

YY/T 0316-2003 Medical devices - Application of risk management to medical devices (ISO 14971:2000, IDT)

YY 0461-2003 Breathing tubes intended for use with aneasthetic apparatus and ventilators (ISO 5367:2000, IDT)

YY 0466-2003 Medical devices - Symbols to be used with medical device labels labelling and information to be supplied (ISO 15223:2000, 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 1040.1-2003 Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:1996, IDT)

ISO 5356-2 Anesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors

ISO 5359 Anesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases

ISO 5362 Anesthetic reservoir bags

ISO 7396-1 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum

ISO 15001 Anesthetic and respiratory equipment - Compatibility with oxygen

IEC 60601-1-8:2003 Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: Alarm systems - Requirements, tests and guidelines - General requirements and guidelines for alarm systems in medical electrical equipment and medical electrical systems

2 Terms and definitions

For the purposes of this document, the terms and definitions given in GB/T 4999-2003, GB 9706.1 AND the following terms and definitions apply to this part of YY 0600. Addition: […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 42 pages — is available in the English PDF.

Referenced standards

Normative references

GB 7144-1999 · ISO 5356-2 · ISO 5359 · ISO 5362 · ISO 7396-1 · ISO 15001 · IEC 60601-1-8:2003

Similar standards

YY 0600.2-2007|YY 0600.4-2013|YY 0600.5-2011|YY 0600.3-2007|YY 9706.279-2023|YY 9706.280-2023

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