BS-7634-1993 ISO-10083-1992.pdf
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1、BRITISH STANDARD BS 7634:1993 ISO 10083: 1992 Specification for Oxygen concentrators for use with medical gas pipeline systems UDC 615.816:621.5.041:546.21 Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 763
2、4:1993 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 March 1993 BSI 09-1999 The following BSI references relate to the work on this standard: Committe
3、e reference HCC/44 Draft for comment 90/56320 DC ISBN 0 580 21631 4 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/44, upon which the following bodies were repres
4、ented: Association of Anaesthetists of Great Britain and Ireland Association of British Health Care Industries Association of Veterinary Anaesthetists of Great Britain and Ireland British Anaesthetic and Respiratory Equipment Manufacturers Association Department of Health Medical Sterile Products As
5、sociation Amendments issued since publication Amd. No.DateComments Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7634:1993 BSI 09-1999i Contents Page Committees responsibleInside front cover National forew
6、ordii Introduction1 1Scope1 2Normative references1 3Definitions1 4Materials2 5Requirements3 6Information4 7Identification4 8Product gas4 Annex A (informative) Recommended minimum requirements for maintenance5 Annex B (informative) Recommendations for installation5 Annex C (informative) Bibliography8
7、 Figure B.1 Typical oxygen concentrator system with integral compressors7 List of referencesInside back cover Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7634:1993 ii BSI 09-1999 National foreword This B
8、ritish Standard has been prepared under the direction of the Health Care Standards Policy Committee and is identical with ISO 10083 Oxygen concentrators for use with medical gas pipeline systems, prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, of the International
9、Organization for Standardization (ISO). Attention is drawn to BS 5724-2.23:1989, which specifies requirements for the safety of oxygen concentrators not used with medical gas pipeline systems. Cross-references. The Technical Committee has reviewed the provisions of ISO 5145:1990, ISO 7396:1987 and I
10、EC 364-2:1970, to which normative reference is made in the text, and has decided that they are acceptable for use in conjunction with this British Standard. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their
11、 correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 to 8, an inside back cover and a back cover. This standard has been updated (see
12、copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7634:1993 BSI 09-19991 Intro
13、duction The purpose of this International Standard is to specify performance and safety requirements for oxygen concentrators connected to medical gas pipeline systems. The basic requirement of the oxygen concentrator is to provide a safe, reliable local source of oxygen-enriched air of sufficiently
14、 high oxygen concentration to supply medical needs. Special consideration has to be given to providing a safe system with adequate reserves since life support is dependent on a non-failing supply. There is more than one way of achieving a high concentration of oxygen. This International Standard spe
15、cifies requirements for the molecular sieve type of oxygen concentrator, also known as a pressure swing adsorber (PSA). Other types will be included when they are at a stage where they can be applied practically to hospital pipeline systems. This International Standard does not purport to guarantee
16、the suitability of the product gas for all clinical procedures, nor does it necessarily imply cost advantages over other methods of oxygen supply; it does, however, lay down the minimum requirements for those circumstances in which hospital authorities choose this method of supply. 1 Scope This Inte
17、rnational Standard specifies requirements for an oxygen concentrator system including a reserve supply, for use with medical gas pipeline systems which comply with ISO 7396, comprising a pressure swing adsorber (PSA) system and its source of air supply. It includes requirements for safety, quality,
18、purity and availability of supply. It also specifies the air source for oxygen concentrators. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions or this International Standard. At the time of publication, the editions indica
19、ted were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid Inte
20、rnational Standards. ISO 407:1991, Small medical gas cylinders Pin-index yoke-type valve connections. ISO 5145:1990, Cylinder valve outlets for gases and gas mixtures Selection and dimensioning. ISO 7396:1987, Non-flammable medical gas pipeline systems. IEC 364-2:1970, Electrical installations of bu
21、ildings Part 2: Fundamental principles. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 (non-flammable medical gas) pipeline system central supply system with control equipment, a pipeline distribution system and terminal units at the point where n
22、on-flammable medical gases may be delivered 3.2 medical oxygen concentrator system, with dedicated air compressors, comprising molecular sieve devices by means of which oxygen-enriched air is produced from ambient air 3.3 primary supply that part of the medical oxygen concentrator system which suppl
23、ies the pipeline distribution system 3.4 secondary supply that part of the medical oxygen concentrator system which automatically supplies the pipeline distribution system when the primary supply fails 3.5 reserve supply that part of the medical oxygen concentrator system, which operates automatical
24、ly, to supply the pipeline distribution system in the event of a failure of the primary and secondary supplies 3.6 control equipment those items which are necessary to maintain the set pressures and the oxygen concentration within the control limits, such as pressure regulators, oxygen analysers, re
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