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YY 0600.1-2007 PDF English

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YY 0600.1-2007: Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 1: Home-care ventilatory support devices
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YY 0600.1-2007150 Add to Cart Auto, 9 seconds. Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 1: Home-care ventilatory support devices Valid

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


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YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.10 C 46 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 1: Home-care ventilatory support devices (ISO 10651-6:2004, MOD) ISSUED ON: JANUARY 31, 2007 IMPLEMENTED ON: FEBRUARY 01, 2008 Issued by: China Food and Drug Administration 3. No action is required - Full-copy of this standard will be automatically & immediately delivered to your EMAIL address in 0~60 minutes.

Table of Contents

Foreword ... 5 Introduction ... 7 1 Scope ... 9 2 Terms and definitions ... 10 3 General requirements ... 12 4 General requirements for tests ... 13 5 Classification ... 13 6 Identification, marking and documents ... 13 7 Power input ... 19 8 Basic safety categories ... 19 9 Removable protective means ... 19 10 Environmental conditions ... 19 11 Not used ... 20 12 Not used ... 20 13 General... 20 14 Requirements related to classification ... 20 15 Limitation of voltage and/or energy ... 21 16 Enclosures and protective covers ... 21 17 Separation ... 21 18 Protective earthing, functional earthing and potential equalization ... 21 19 Continuous leakage currents and patient auxiliary currents ... 21 20 Dielectric strength ... 21 21 Mechanical strength ... 22 22 Moving parts ... 22 23 Surfaces, corners and edges ... 22 24 Stability in normal use ... 22 25 Expelled parts ... 22 26 Vibration and noise ... 22 27 Pneumatic and hydraulic power ... 22 28 Suspended masses ... 22 29 X-ray radiation ... 22 30 α, β, γ, neutron radiation and other particle radiation ... 23 31 Microwave radiation ... 23 32 Light radiation (including lasers) ... 23 33 Infra-red radiation ... 23 34 Ultra-violet radiation ... 23 35 Acoustical energy (including ultrasonic) ... 23 36 Electromagnetic compatibility ... 23 37 Locations and basic requirements ... 24 38 Marking, accompanying documents ... 24 39 Common requirements for category AP and category APG equipment . 24 40 Requirements and tests for category AP equipment, parts and components thereof ... 24 41 Requirements and tests for category APG equipment, parts and components thereof ... 24 42 Excessive temperature ... 24 43 Fire prevention ... 24 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility ... 25 45 Pressure vessels and parts subject to pressure ... 27 46 Human errors ... 27 47 Electrostatic charges ... 27 48 Biocompatibility ... 27 49 Interruption of the power supply ... 27 50 Accuracy of the operating data ... 28 51 Protection against hazardous output ... 28 52 Abnormal operation and fault conditions ... 30 53 Environmental tests ... 31 54 General... 31 55 Enclosures and covers ... 31 56 Components and general assembly ... 31 57 Mains parts, components and layout ... 34 58 Protective earthing - Terminals and connections ... 34 59 Construction and layout ... 34 101 Alarm systems ... 34 102 Appendix of general standard ... 34 Appendix AA (Informative) Rationale ... 36 References ... 42 Figure 101 -- Configuration of test apparatus for measurement of expiratory pressure and volume ... 30 Table 101 -- Conditions for expiratory pressure and volume measurements ... 30

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”. Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 1: Home-care ventilatory support devices

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) GB7144-1999 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, GB9706.1 AND the following terms and definitions apply to this part of YY 0600. Addition: ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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