BS EN 14931-2006 Pressure vessels for human occupancy (PVHO) - Multi-place pressure chambers for hyperbaric therapy - Performance safety requirements and testing《载人高压氧仓(PVHO) 高压治疗用.pdf
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1、BS EN 14931:2006ICS 11.040.60NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPressure vessels forhuman occupancy(PVHO) Multi-placepressure chambers forhyperbaric therapy Performance, safetyrequirements andtestingLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDA
2、RDS, 25/09/2008 07:46, Uncontrolled Copy, (c) BSIThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 July 2008 BSI 2008ISBN 978 0 580 53337 2Amendments/corrigenda issued since publicationDate CommentsBS EN 14931:2006National forewordThis British S
3、tandard is the UK implementation of EN 14931:2006.The UK participation in its preparation was entrusted to TechnicalCommittee CH/100/-/1, Multi-occupancy hyperbaric chambers for use asmedical devices.A list of organizations represented on this committee can be obtained onrequest to its secretary.Thi
4、s publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 25/09/2008 07:46, Uncontrolled
5、 Copy, (c) BSIBS EN 14931:2006EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 14931June 2006ICS 11.040.60English VersionPressure vessels for human occupancy (PVHO) - Multi-placepressure chamber systems for hyperbaric therapy -Performance, safety requirements and testingChambres hyperbares occupati
6、on humaine - Chambreshyperbares multiplaces usage thrapeutique -Performances, exigences de scurit et essaisDruckkammern fr Personen - Mehrpersonen-Druckkammersysteme fr hyperbare Therapie - Leistung,sicherheitstechnische Anforderungen und PrfungThis European Standard was approved by CEN on 27 April
7、2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained o
8、n application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat
9、has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Rom
10、ania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedwor
11、ldwide for CEN national Members.Ref. No. EN 14931:2006: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 25/09/2008 07:46, Uncontrolled Copy, (c) BSIBS EN 14931:2006EN 14931:2006 (E) 2 Contents Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Perf
12、ormance, safety requirements and testing 6 4.1 General6 4.2 General requirements common to ante chamber and main chamber7 4.3 Main chamber requirements.12 4.4 Ante chamber requirements.14 4.5 Control console15 4.6 Compressed air supply system18 4.7 Treatment gas supply19 4.8 Communications22 4.9 Eme
13、rgency power supply .22 5 Operating instructions 23 6 Marking .24 Annex A (normative) Adaptor set for compression chambers 25 A.1 General25 A.2 Standard connections or adaptor set required for the interchangeability of compression chambers25 A.3 Adaptor set female coupling (locking ring) 26 A.4 Adap
14、tor set male coupling (reducing ring) .27 A.5 Basic dimensions for a treatment chamber to allow mating with a transport chamber 28 A.6 Basic dimensions for a transport chamber to allow mating with a treatment chamber 29 Annex B (informative) Recommendations for medical devices used in hyperbaric cha
15、mber systems 30 B.1 General30 B.2 Pressure30 B.3 Oxygen31 B.4 Electricity32 B.5 Typical medical equipment which may be required for critical care33 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC .36 Bibliography39 Licensed C
16、opy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 25/09/2008 07:46, Uncontrolled Copy, (c) BSIBS EN 14931:2006EN 14931:2006 (E) 3 Foreword This document (EN 14931:2006) has been prepared by CEN/BT/TF 127 “Hyperbaric therapy chambers”, the secretariat of which is held by DIN. This European Standard shall
17、be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2006, and conflicting national standards shall be withdrawn at the latest by December 2006. This document has been prepared under a mandate given to CEN by the European
18、 Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organiza
19、tions of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovak
20、ia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 25/09/2008 07:46, Uncontrolled Copy, (c) BSIBS EN 14931:2006EN 14931:2006 (E) 4 Introduction Pressure chambers for therapeutic use are required for the administration of hyperbaric oxy
21、gen therapy and for the treatment of decompression illness. These chambers are made to allow the safe administration of hyperoxic gas mixtures at pressure while avoiding the risks of fire within the chamber and of uncontrolled compression or decompression. They need to allow all levels of patient ca
22、re up to intensive care with all the necessary equipment and provide a safe working environment for patient carers. Standards on ergonomics for the design of pressure chambers for therapeutic use are not available. Nevertheless guidance for the application of ergonomics standards is given in the bib
23、liography. Chambers providing exclusively for hyperbaric oxygen therapy operate typically with a maximum operational pressure of 200 kPa (2 bar) above atmospheric pressure. Pressure chambers providing treatment for decompression illness have a maximum operating pressure of 500 kPa (5 bar) or more. T
24、reatment times in the chamber are typically 2 h to 3 h for hyperbaric oxygen treatments while standard treatment for decompression illness may last 8,5 h or more. Atmospheric conditions within the chamber need to be comfortable and, in particular, oxygen levels require control in order to avoid hypo
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