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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
25、lief valves, alarm initiators, manual and automatic valves 3.7 pipeline distribution system that part of a pipeline system linking the source of supply to the terminal units, including any necessary branch isolation valves and any additional line pressure regulators required to reduce further the pr
26、essure in a part of the distribution system, downstream of the source of supply 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 2 BSI 09-1999 3.8 terminal unit outlet assembly (inlet for vacuum), i
27、n a medical gas pipeline distribution system, at which the user makes connections and disconnections NOTE 1The requirements for terminal units are specified in ISO 9170 3. 3.9 shut-off valve; isolation valve manual or automatic valve which prevents flow in both directions when closed 3.10 non-return
28、 valve valve which permits flow in one direction only 3.11 gas-specific having characteristics which prevent interchangeability and thereby allow assignment to one gas service only 3.12 pressure-safety valve valve to limit the pressure in the pipeline downstream of the pressure regulators 3.13 press
29、ure relief valve valve to limit the pressure downstream of any operating pressure line regulator 3.14 operating alarm visual, or visual and auditory, alarm to indicate the necessity for technical staff to adjust the supply or correct a malfunction 3.15 emergency alarm visual or auditory alarm to ind
30、icate to technical or medical staff that the supply is outside normal operating limits 3.16 nominal operating pressure pressure at which the system is designed to operate 3.17 rated capacity flow that the oxygen concentrator system can maintain continuously without the secondary supply (if provided)
31、 or reserve supply coming into operation 3.18 molecular sieve device device that increases the oxygen concentration of ambient air by adsorbing nitrogen and some other gaseous components 3.19 product gas oxygen-enriched air produced by the molecular sieve process 3.20 oxygen 93 % oxygen-enriched air
32、 containing not less than 90 % and not more than 96 % (V/V) oxygen, the remainder comprising predominantly argon and/or nitrogen 3.21 pressure vessel container which holds or can withstand a pressure higher than atmospheric pressure 4 Materials 4.1 Compatibility with oxygen The components of medical
33、 oxygen concentrator systems, including any components connected to any outlet of the molecular sieve device which come into contact with oxygen-enriched air, shall be compatible with oxygen 99 % under all operating conditions, and shall be clean and free from oil, grease and particulate matter. The
34、 anti-corrosion properties of all components against oxygen, moisture and surrounding materials should also be considered. Components should be of materials as specified in Annex A of ISO 7396:1987. NOTE 2Compatibility involves both combustibility and ease of ignition. Materials which burn in air bu
35、rn violently in pure oxygen, particularly under pressure. Similarly, materials which can be ignited in air require lower ignition energies in oxygen. Many such materials may be ignited by friction, at a valve seat or stem packing, by adiabatic compression, produced when oxygen at high pressure is ra
36、pidly introduced into a system at low pressure. 4.2 Cleaning All pipes, valves and fittings in contact with the product gas in normal use or under single-fault condition shall be cleaned and degreased before assembly. Precautions should be taken to maintain cleanliness during installation. Licensed
37、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 09-19993 5 Requirements 5.1 General NOTE 3A typical oxygen concentrator system is shown in Figure B.1. 5.1.1 The system shall comprise a primary, a second
38、ary and a reserve supply and shall be designed for automatic operation. 5.1.2 The product gas from both the primary and secondary supplies shall comply with clause 8. 5.1.3 The plant shall be designed, manufactured and tested in accordance with the current national pressure vessel codes. 5.1.4 All e
39、lectrical wiring shall comply with IEC 364-2. 5.2 Air supply 5.2.1 Each molecular sieve device shall have at least one air compressor. NOTE 4Each compressor may be arranged to supply other molecular sieve devices in the event of failure of its own molecular sieve device (see Figure B.1). 5.2.2 Air c
40、ompressors within the medical oxygen concentrator system shall be provided with a filter for protection of components. 5.3 Filtration Downstream of the molecular sieve device there shall be a filter of 0,3 4m coalescing type 99 % efficiency to ensure that the product gas meets the particulate requir
41、ements of clause 8. 5.4 Booster compressor If compressors are used to compress oxygen 93 % to the pipeline distribution pressure, they shall be of a design compatible with oxygen 99 % and shall be provided for each molecular sieve device. 5.5 Reserve supplies The reserve supply shall be as specified
42、 in ISO 7396 with the amendments in 5.5.1 to 5.5.4. 5.5.1 Either a) the reserve supply shall be oxygen 93 %; or b) if national regulations endorsed by national medical professional societies regard oxygen 93 % and oxygen 99 % as totally interchangeable, the reserve supply shall be oxygen 93 % or oxy
43、gen 99 %. 5.5.2 The reserve supply shall have the rated capacity of the plant as specified in 6.1 a), and shall be capable of supplying the rated capacity for a minimum of 1 h from attached cylinders. (See B.4.) 5.5.3 The reserve supply shall be a supply system with pressure vessels (e.g. cylinders)
44、 comprising primary and secondary supplies, with automatic changeover. 5.5.4 The reserve supply shall discharge gas into the pipeline distribution system downstream of the non-return valve installed in the product gas line from the oxygen concentrator system. 5.6 Pressure control equipment The oxyge
45、n concentrator supply system shall include a duplex pressure regulating and relief valve assembly designed to maintain pipeline distribution pressure as shown in Figure B.1. 5.7 Control and monitoring 5.7.1 The control system shall include an oxygen analyser to monitor and display the oxygen concent
46、ration of the product gas continuously. This device shall include compensation for temperature and barometric pressure variations to ensure an accuracy of 1 % of the measured value over all operating conditions. 5.7.2 The control system shall include a device which continuously records the oxygen co
47、ncentration of the product gas. 5.7.3 The control system shall effect automatic changeover as follows: from primary to secondary supply in the event of failure (pressure or oxygen concentration) of the primary supply; from secondary supply to the reserve supply in the event of failure (pressure or o
48、xygen concentration) of the secondary supply. 5.7.4 A second independent oxygen analyser complying with 5.7.1 and 5.7.2 shall be provided to monitor and display the final concentration of the product gas continuously. 5.7.5 The analyser specified in 5.7.4 shall be provided with means to isolate auto
49、matically the primary and secondary supplies immediately upstream of the reserve supply if oxygen purity outside the limits specified in 5.1.2 is detected. 5.7.6 The control unit shall be designed so that shutting off or failure of one of the compressors or molecular sieve devices shall not affect the operation or the other units. 5.7.7 The control system shall monitor the oxygen concentration of the output of the reserve supply filling system (if included) and shall automatically isolate the filling system if a concentration outside the limits specified in clause