YY 0732-2009Oxygen concentrators for medical use—Safety requirements (English PDF)
医用氧气浓缩器 安全要求
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
June 16, 2009
Implementation date
December 1, 2010
Scope
YY 0732-2009 is the English-translated version of 医用氧气浓缩器 安全要求.
YY 0732-2009 is the Chinese pharmaceutical industry standard that sets the safety requirements for the continuous flow oxygen concentrator used in medicine.
It covers the oxygen concentration delivered and its monitoring, the flow rate and its accuracy, the alarms that warn of failure, the filters and the noise, the enclosure and the electrical safety, and it is not limited to membrane and pressure swing adsorption concentrators, since other ways of enriching oxygen may appear.
It does not apply to concentrators supplying several patients through a medical gas pipeline, nor to use where flammable anaesthetic gases or cleaning agents are present. Issued on 16 June 2009, it has applied since 1 December 2010.
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Document preview — YY 0732-2009
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
Foreword
This standard is equivalent to international standards ISO 8359:1996 "medical oxygen concentrators safety requirements." The standard ISO 8359:1996 made the following editorial changes.
--- "This International Standard" be replaced by "this standard";
--- With a decimal point '. 'Instead of a comma as the decimal point,' ';
--- Delete foreword international standards;
The standard 5.8 Electromagnetic compatibility and YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety juxtaposition Standard. Electromagnetic Compatibility - Requirements and test the implementation of the same period. " Appendix Appendix A ~ N form an integral part of this standard, normative appendix, Appendix P informative appendices.
Introduction
Oxygen concentrators oxygen enriched air to provide security for the patient. Such devices by separating nitrogen or oxygen from ambient air can be improved Inhaled oxygen concentration.
The gas separated manner, oxygen concentrators can be divided into two categories.
a) oxygen selectively permeates through the membrane or mesh or sieve oxygen concentrators;
b) pressure swing adsorption (PSA) oxygen concentrator, air under pressure in contact with the molecular sieve materials, the molecular sieve material selectively absorbing Attached nitrogen or other ingredients, and then, when you reduce the pressure to release it.
Appendix N to give a detailed description of a series of trials to test experimental equipment arrangement meets the specific requirements.
The most important requirement is given in Appendix P of the basic principles. The basic principle of such requirements is not only conducive to the proper use of this standard, and can be Simplify subsequent modifications.
Test methods may also be used in this standard does not specify to verify compliance with the requirements given, but these methods must have the same or more High accuracy. Any discrepancy, the method specified in this standard as a reference method. Safety requirements for medical oxygen concentrators Chapter 1 Overview
1.1 Scope and purpose
Note 1. See Appendix P of the basic principles.
This standard is based on a series of standard GB 9706.1-2007 one. GB 9706.1-2007 (General Standard) in such Standard is called "specific standard" (ParticularStandard). According to the provisions of GB 1.3 9706.1-2007, advantages of the present standard requirements
GB 9706.1-2007 prior to the request.
In addition to the following section to replace 1.1, GB 9706.1-2007 Chapter 1 apply.
This standard specifies the safety requirements for continuous flow oxygen concentrator (see 1.3.8 of this standard) in. This standard is not applicable with pipe Medical gas installation path to a number of patients supply of oxygen concentrator, nor applied in a flammable anesthetic gas and/or cleaning agents conditions Oxygen concentrators used.
The scope of the standard is not limited to film and PSA oxygen concentrators oxygen concentrator (see "Introduction"), because there may be other Concentrated oxygen method, and the present standard should not limit future development.
1.2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequently Some amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Study whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/Determination of sound power levels of noise sources reflecting plane free field engineering law (eqv T 3767-1996 Acoustics sound pressure
ISO 3744:1994)
GB/T 3785-1983 electric sound level meter, acoustic performance and test methods 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.
YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests (IEC 601-1-2:2001, IDT)
YY 0574.1-2005 anesthesia and respiratory care alarm signals - Part 1. Visual alarm signals (ISO 9703-1:1992, IDT)
YY 0574.2-2005 anesthesia and respiratory care alarm signals - Part 2.
1.3 Terms and Definitions
In addition to the following section to replace 2.1.5, GB 9706.1-2007 Chapter 2 apply.
1.3.1 Product gas delivery
The product gas is transferred from the oxygen concentrator outlet to annex all patients, but does not include any fixed extension tube.
2.1.5 Oxygen concentrator outlet
The following terms and definitions apply to this same standard.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 3785-1983Electroacoustics - Sound level meters - Part 1: Specifications
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- YY 0505-2005Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- YY 0574.1-2005Anesthesia and respiratory care alarm signals - Part 1: Visual alarm signals
- YY 0574.2-2005Anaesthesia and respiratory care alarm signals - Part 2: Auditory alarm signal
ISO 3744:1994 · GB 9706.29-2006
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Related Standards
GB/T 3785-1983 — Electroacoustics - Sound level meters - Part 1: Specifications
YY 0505-2005 — Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
YY 0574.1-2005 — Anesthesia and respiratory care alarm signals - Part 1: Visual alarm signals
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YY 0732-2009
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