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YY 0635.4-2009Inhalational anaesthesia systems - Part 4: Requirements for anaesthetic ventilators (English PDF)

吸入式麻醉系统 第4部分:麻醉呼吸机

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

June 16, 2009

Implementation date

December 1, 2010

Scope

YY 0635.4-2009 is the English-translated version of 吸入式麻醉系统 第4部分:麻醉呼吸机.

YY 0635.4-2009 is the Chinese standard "Inhalational anaesthesia systems - Part 4: Requirements for anaesthetic ventilators". Its scope clause reads: In addition to the following, GB 9706.1-2007 Chapter 1 applies.

This part of YY 0635 is based on the specific standards of GB 9706.1-2007. As described in 1.3 of GB 9706.1-2007 , The requirements of this part are more effective than the relevant requirements of GB 9706.1.

If in this section the clause of GB 9706.1-2007 is declared Is applicable, it means that the provision applies only if the request is related to the anesthesia ventilator under consideration.

This section specifies the specific requirements for the basic performance of anesthesia ventilator (see definition of 2.1). The anesthesia ventilator referred to in this section is usually The components of an anesthesia system are intermittently engaged by an operator.

Anesthesia ventilators for use with flammable anesthesia equipment, as defined in Appendix BB, are outside the scope of application of this section. Its clauses include normative reference documents; terms and definitions.

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Document preview — YY 0635.4-2009

National Standard of the People's Republic of China

ICS
11.040.10
Classification
C 46

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

Contents

  • Foreword
  • Introduction
  • 1 Scope
  • 2 Normative reference documents
  • 3 Terms and definitions

1 Scope

In addition to the following, GB 9706.1-2007 Chapter 1 applies.

This part of YY 0635 is based on the specific standards of GB 9706.1-2007. As described in 1.3 of GB 9706.1-2007 , The requirements of this part are more effective than the relevant requirements of GB 9706.1. If in this section the clause of GB 9706.1-2007 is declared

Is applicable, it means that the provision applies only if the request is related to the anesthesia ventilator under consideration.

This section specifies the specific requirements for the basic performance of anesthesia ventilator (see definition of 2.1). The anesthesia ventilator referred to in this section is usually

The components of an anesthesia system are intermittently engaged by an operator.

Anesthesia ventilators for use with flammable anesthesia equipment, as defined in Appendix BB, are outside the scope of application of this section.

2 normative reference documents

The terms of this document are the terms of this part of the terms of this part of YY 0635. Any reference to the date of the document,

All subsequent amendments (excluding corrigenda) or revisions do not apply to this part, however, it is encouraged to enter into an agreement under this Part

Of the parties to study whether the latest version of these documents can be used. For undated references, the latest edition of this section applies.

GB 3836.4 Electrical equipment for explosive gas atmospheres - Part 4. Intrinsically safe "i" (GB 3836.4-2000, eqv IEC 60079-11..1999)

GB/T 4999-2003 Terminology for anesthesia and respiratory equipment (ISO 4135..2001, IDT)

Test method for flammable liquids and gases - Ignition temperature (IEC 60079-4. 1975, IDT) GB/T 5332-2007

GB 7899-2006 Cylinder pressure reducers for welding, cutting and similar processes (ISO 2503..1998, MOD)

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

GB 9706.29-2006 Medical electrical equipment - Part 2. Particular requirements for the safety and basic performance of anesthesia systems (IEC 60601-

2-13.2003, MOD)

General technical conditions for cylinder valves GB 15382-1994

YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests (IEC 60601-1-2..2001, IDT)

YY 1040.1-2003 Anesthesia and respiratory equipment - Conical joints - Part 1. Cone and taper sleeves (ISO 5356-1..1996, IDT)

YY 1040.2-2008 Conjugates for anesthesia and respiratory equipment - Part 2. Threaded load - bearing joints (ISO 5356-2..2006,

IDT)

Inhalation anesthesia system - Part 1. Adult anesthetic respiratory system (ISO 8835-2..1999, IDT)

Inhalation anesthesia systems - Part 2. Anesthetic gas purification system delivery and collection systems (ISO 8835 -

3..1997, IDT)

ISO 5359..2000 Low pressure flexible connection hose assemblies for medical gas systems

ISO 7396-1 Medical gas piping systems - Part 1. Compressed medical gases and vacuum piping

3 terms and definitions

GB 9706.1-2007, GB/T 4999-2003 and GB 9706.29-2007 and the following terms and definitions apply to

YY 0635 this part.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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