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YY 0635.3-2009Inhalational anaesthesia systems - Part 3: Anaesthetic vapour delivery devices (English PDF)

吸入式麻醉系统 第3部分:麻醉气体输送装置

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

June 16, 2009

Implementation date

December 1, 2010

Scope

YY 0635.3-2009 is the English-translated version of 吸入式麻醉系统 第3部分:麻醉气体输送装置.

YY 0635.3-2009 is the Chinese standard "Inhalational anaesthesia systems - Part 3: Anaesthetic vapour delivery devices". Its scope clause reads: Except for the following, GB 9706.1-2007 Chapter 1 apply. increase.

YY 0635 This section provides for the anesthetic gas delivery device (AVDD) (as defined in 3.1) basic safety and performance requirements. it Suitable for use as a component of the anesthesia system and anesthetic gases for continuous operative care of the delivery device (AVDD).

This section Anesthetic gas delivery device (AVDD) presents special requirements then its general requirements GB 9706.29-2006 apply. This section does not apply, as defined in Appendix CC flammable anesthetic anesthesia systems, and the use of anesthesia in the respiratory system Anesthetic gas delivery device (the AVDD) (e.g. suction evaporator).

If the requirements of this section to replace or modify the relevant requirements GB 9706.1-2007, the priority claim in the corresponding general Claim. Its clauses include terms and definitions.

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Document preview — YY 0635.3-2009

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 references
  • 3 Terms and Definitions

1 Scope

Except for the following, GB 9706.1-2007 Chapter 1 apply.

increase.

YY 0635 This section provides for the anesthetic gas delivery device (AVDD) (as defined in 3.1) basic safety and performance requirements. it

Suitable for use as a component of the anesthesia system and anesthetic gases for continuous operative care of the delivery device (AVDD). This section

Anesthetic gas delivery device (AVDD) presents special requirements then its general requirements GB 9706.29-2006 apply.

This section does not apply, as defined in Appendix CC flammable anesthetic anesthesia systems, and the use of anesthesia in the respiratory system

Anesthetic gas delivery device (the AVDD) (e.g. suction evaporator).

If the requirements of this section to replace or modify the relevant requirements GB 9706.1-2007, the priority claim in the corresponding general

Claim.

2 Normative references

The following documents contain provisions which, through reference in this section YY 0635 constitute provisions of this section. Cited documents dated, its

All subsequent amendments (excluding corrections) or revisions do not apply to this section, however, encourage an agreement under this section

Parties to study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.

GB 3836.4-2000 Electrical equipment for explosive gas atmospheres Part 4 by. Intrinsic safety "i" (eqv IEC 60079-11.

1999)

GB/T 4999-2003 term anesthesia breathing equipment (ISO 4135.2001, IDT)

Temperature test method GB/T 5332-2007 ignition of flammable liquids and gases (IEC 60079-4. 1975, IDT)

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. safety and essential performance of anesthetic systems (IEC 60601-2-13.

2003, MOD)

YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests (IEC 60601-1-2.2001, IDT)

YY 0601-2007 anesthetic gas monitors (ISO 11196.1995, IDT)

YY 1040.1-2003 anesthesia and respiratory equipment - Conical fittings - Part 1. Cone and drogue (ISO 5356-1.1996, IDT)

YY 0635.2-2009 inhalation anesthesia systems - Part 2. anesthetic gas purification system delivery and collection systems (ISO 8835-

3.1997, IDT)

IEC 60601-1-6 Medical electrical equipment - Part 1-6. General requirements for safety - Collateral standard. Usability

ISO 5360-2006 anesthesia machine evaporator special agent filling system

3 Terms and Definitions

GB/T 4999-2003, GB 9706.29-2006 established and the following terms and definitions apply to this part YY 0635.

3.1

Providing anesthetic vapor concentration controllable devices.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.

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