EN 14931-2006 en Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance safety requirements and testing《病员用高压仓(PVHO.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 andtestingThis British Standardwas published under theauthor

2、ity 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 Standard is the UK implementation of EN 14931:2006.The UK participation in its preparation was entru

3、sted 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.This publication does not purport to include all the necessary provisionsof a contract. Users are resp

4、onsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS EN 14931:2006EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 14931June 2006ICS 11.040.60English VersionPressure vessels for human occupancy (PVHO) - Multi-placepressure chamber sy

5、stems for hyperbaric therapy -Performance, safety requirements and testingChambres hyperbares occupation humaine - Chambreshyperbares multiplaces usage thrapeutique -Performances, exigences de scurit et essaisDruckkammern fr Personen - Mehrpersonen-Druckkammersysteme fr hyperbare Therapie - Leistung

6、,sicherheitstechnische Anforderungen und PrfungThis European Standard was approved by CEN on 27 April 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 alteratio

7、n. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on 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 translationu

8、nder the responsibility of a CEN member into its own language and notified to the Central Secretariat 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, Ice

9、land, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Sta

10、ssart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14931:2006: EBS 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 P

11、erformance, 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

12、Emergency 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 A

13、daptor 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

14、chamber 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 BS EN 1

15、4931:2006EN 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 be given the status of a national standard, either by publication of an identical text or by end

16、orsement, 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 Commission and the European Free Trade Association, and supports essential requirements of EU D

17、irective(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 organizations of the following countries are bound to implement this European Standard: Austria, Belgium

18、, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. BS EN 14931:2006EN 14931:2006 (E) 4

19、 Introduction Pressure chambers for therapeutic use are required for the administration of hyperbaric oxygen 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

20、the chamber and of uncontrolled compression or decompression. They need to allow all levels of patient care 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

21、 are not available. Nevertheless guidance for the application of ergonomics standards is given in the bibliography. Chambers providing exclusively for hyperbaric oxygen therapy operate typically with a maximum operational pressure of 200 kPa (2 bar) above atmospheric pressure. Pressure chambers prov

22、iding treatment for decompression illness have a maximum operating pressure of 500 kPa (5 bar) or more. Treatment 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 th

23、e chamber need to be comfortable and, in particular, oxygen levels require control in order to avoid hypoxia, oxygen toxicity and undue risk of fire. BS EN 14931:2006EN 14931:2006 (E) 5 1 Scope This European Standard is applicable to the performance and safety requirements and their associated test

24、methods for multi-place pressure chambers designed for pressures in excess of ambient atmospheric pressure and employed in medical installations for therapeutic purposes, in the following referred to as pressure chambers. 2 Normative references The following referenced documents are indispensable fo

25、r the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 737-1:1998, Medical gas pipeline systems Part 1: Terminal units for compressed medical gases and vacu

26、um EN 739:1998, Low-pressure hose assemblies for use with medical gases EN 837-1, Pressure gauges Part 1: Bourdon tube pressure gauges Dimensions, metrology, requirements and testing EN 1041:1998, Information supplied by the manufacturer with medical devices EN 1865, Specifications for stretchers an

27、d other patient handling equipment used in road ambulances EN 12021, Respiratory protective devices Compressed air for breathing apparatus EN 13348, Copper and copper alloys Seamless, round copper tubes for medical gases or vacuum EN 13445-5, Unfired pressure vessels Part 5: Inspection and testing E

28、N ISO 6941, Textile fabrics Burning behaviour Measurement of flame spread properties of vertically oriented specimens (ISO 6941:2003) EN ISO 14971, Medical devices Application of risk management to medical devices (ISO 14971:2000) EN ISO 15001, Anaesthetic and respiratory equipment Compatibility wit

29、h oxygen (ISO 15001:2003) ISO 6309:1987, Fire protection Safety signs IEC 60364-7-710, Electrical installations of buildings Part 7-710: Requirements for special installations or locations; Medical locations FMVSS 49 CFR 571 302, Flammability of interior materials 3 Terms and definitions For the pur

30、poses of this document, the following terms and definitions apply. 3.1 hyperbaric chamber system consists of a pressure chamber and its supporting equipment NOTE Supporting equipment is equipment needed to operate the pressure chamber, e.g. gas supply, control panel, and safety equipment. 3.2 main c

31、hamber/main lock part of the pressure chamber used for carrying out therapy BS EN 14931:2006EN 14931:2006 (E) 6 3.3 ante chamber/entry lock part of the pressure chamber used for locking in and out persons and equipment 3.4 relative (gauge) pressure pressure defined as p - pamb, where pambis the ambi

32、ent pressure. Thus the gauge pressure is positive or negative according as p is larger or smaller than pambrespectively ISO 31-3:1992, 3-15.1 NOTE All pressures in this European Standard are expressed as relative (gauge) pressures. The Directive defines: “Pressure means pressure relative to atmosphe

33、ric pressure, i.e. gauge pressure. As a consequence, vacuum is designated by a negative value.“ 3.5 maximum allowable pressure/design pressure (MAP) maximum pressure for which the equipment is designed, as specified by the manufacturer 3.6 test pressure excess pressure to which components or one com

34、ponent are subjected for test purposes NOTE Test pressure is referred as “hydrostatic test pressure“ in Directive 97/23/EC. 3.7 maximum operational pressure maximum pressure under which the equipment is used for therapeutic purposes NOTE The operational pressure is referred as “pressure“ in Directiv

35、e 97/23/EC. 3.8 single fault condition condition in which a single means for protection against a safety hazard in equipment is defective or a single external abnormal condition is present 3.9 treatment gas medical gas or mixture of gases administered to the patient for treatment 4 Performance, safe

36、ty requirements and testing 4.1 General As medical devices, hyperbaric chamber systems shall be in accordance with the Directive 93/42/EC on medical devices. Pressurised components within such systems shall be in accordance with the Directive 97/23/EC on pressure equipment. Hyperbaric pressure chamb

37、er systems shall, when installed, commissioned, operated in normal use and maintained according to the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk analysis procedures in accordance with EN ISO 14971 in regard to their intended application, in normal co

38、ndition and in single fault condition. Hyperbaric chamber systems and components or parts thereof, using materials or having forms of construction different from those detailed in this European Standard, shall be accepted if it can be demonstrated that an equivalent degree of safety is obtained. Suc

39、h evidence shall be provided by the manufacturer. NOTE Evidence will be provided to e.g. a Notified Body during EC conformity assessment and on request to the competent authority. An example of risk analysis is given in the European Code of Good Practice for Hyperbaric Oxygen Therapy. BS EN 14931:20

40、06EN 14931:2006 (E) 7 4.2 General requirements common to ante chamber and main chamber 4.2.1 Pressure chambers shall comprise at least two compartments an ante chamber and a main chamber. Each compartment including supply lock shall be designed for a test pressure according to Table 1. Testing: Shal

41、l be according to EN 13445-5. 4.2.2 The gas used to pressurise the chamber shall never contain more than 21 % oxygen. 4.2.3 Pressure chambers shall be designed such that an operational pressure of at least 200 kPa (2 bar) can be reached and maintained. 4.2.4 The relationship between test pressure, m

42、aximum allowable pressure/design pressure, maximum operational pressure and atmospheric pressure is specified in Table 1. Table 1 Relationship between test pressure, maximum allowable pressure/design pressure, maximum operational pressure and atmospheric pressure Pressure Value Test pressure 1,43 MA

43、P Maximum allowable pressure/Design pressure 1 MAP Maximum operational pressure 0,91 MAP Atmospheric pressure 0 kPa (0 bar) Testing: Verification as to whether the values stipulated for the ante chamber and the main chamber are complied with. 4.2.5 Breathing units 4.2.5.1 For each person to be accom

44、modated according to 4.3.3 and 4.4.1 a breathing unit for treatment gas shall be available independent from chamber atmosphere. Testing: Checking by inspection of the installation as to whether an adequate number of breathing units are provided. 4.2.5.2 The treatment gas can be delivered by a free f

45、low system or by a demand system or by a system for the artificial ventilation of the lung. Each individual breathing unit shall be suitable for operation in a hyperbaric chamber system (for information refer to Annex B) It shall be equipped with a system able to completely discharge exhaled gas / v

46、entilation gas out of the chamber (overboard dumping). BS EN 14931:2006EN 14931:2006 (E) 8 Testing: Checking by inspection of the piping system as to whether it is possible for the gas to be passed out from the chamber. 4.2.5.3 If the treatment gas is supplied via a demand system then, with a chambe

47、r pressure of 150 kPa (1,5 bar) and a minimum breathing volume of 22,5 l/min (1,5 l/breath x 15 breaths/minute), measured at the pressure within the chamber, the pressure drop to open inhalation and exhalation valves shall not be higher than - 0,3 kPa (- 3 mbar) and + 0,3 kPa (+ 3 mbar), respectivel

48、y. The maximum pressure in the mask shall not exceed + 0,5 kPa (+ 5 mbar) and the minimum pressure in the mask shall not be less than - 0,5 kPa (- 5 mbar). Testing: Checking of manufacturers certificate as to compliance of the source for treatment gas with the requirements; 4.2.5.4 operational test

49、of each breathing unit under pressure. Means to regulate the flow in breathing systems other than demand valve systems shall be provided. Testing: Operational test of each breathing unit under pressure. 4.2.6 Pressure chambers shall be equipped with safety devices which shall not respond until the maximum operational pressure to be maintained according to 4.2.4 has been exceeded and shall close before the pressure drops below this maximum operational pressure. The safety devices shall be mounted to the pressure chamber in such a way that they