BS EN ISO 15001-2011 Anaesthetic and respiratory equipment Compatibility with oxygen《麻醉和呼吸设备 氧气的可混用性》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 15001:2011Anaesthetic and respiratoryequipment Compatibilitywith oxygen (ISO 15001:2010)BS EN ISO 15001:2011 BRITISH STANDARDNational forewordThis British Standard is t

2、he UK implementation of EN ISO15001:2011. It is identical to ISO 15001:2010. It supersedes BS EN ISO15001:2010 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/6, Medical gas supply systems.A list of organizations represented on this committee can

3、 beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 76945 0ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations

4、.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15001 October 2011 ICS 11.040.40 Supersedes EN ISO 15001:2010Englis

5、h Version Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) Matriel danesthsie et de ranimation respiratoire - Compatibilit avec loxygne (ISO 15001:2010) Ansthesie- und Beatmungsgerte - Vertrglichkeit mit Sauerstoff (ISO 15001:2010) This European Standard was approve

6、d by CEN on 20 September 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national

7、 standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language

8、and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

9、Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2

10、011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15001:2011: EBS EN ISO 15001:2011EN ISO 15001:2011 (E) 3 Foreword This document (EN ISO 15001:2011) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respir

11、atory equipment“ in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest

12、by April 2012, and conflicting national standards shall be withdrawn at the latest by April 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such pat

13、ent rights. This document supersedes EN ISO 15001:2010. This edition contains a revised Annex ZA. 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 Directive. For relationship wit

14、h EU Directive, 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, Bulgaria, Croatia, Cyprus, Czech R

15、epublic, 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 the United Kingdom. Endorsement notice The text of ISO 15001:2010 ha

16、s been approved by CEN as EN ISO 15001:2011 without any modification. BS EN ISO 15001:2011EN ISO 15001:2011 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given

17、 to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC Medical Devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been i

18、mplemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA r

19、egulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Medical Devices Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/NotesThis standard specifies minimum requirements for the oxygen compatibility of mate

20、rials components and devices that can come into contact with oxygen in normal or single fault condition. All its requirements aim at minimising the risk of fire/oxidation and the consequences to the patients treated by devices connected to the concerned pipeline/devices system. 4, 5, 6 7.1 first ind

21、ent Risks other than risks to patients resulting from combustion/oxidation are not addressed. 4, 5, 6 7.3 Only for aspects of oxygen compatibility. 4, 5, 6 9.2 first indent Only risks of injury linked with sudden increase of pressure, temperature due to fire are covered. 4, 5, 6 9.3 Only for aspects

22、 of oxygen compatibility. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 15001:2011ISO 15001:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1* Scope1 2 Normative references1

23、 3 Terms and definitions .1 4 Cleanliness.2 5* Resistance to ignition .3 6 Risk management3 Annex A (informative) Examples of cleaning procedures 4 Annex B (informative) Typical methods for validation of cleaning procedures.11 Annex C (informative) Design considerations .14 Annex D (informative) Sel

24、ection of materials.19 Annex E (informative) Recommended method for combustion and quantitative analysis of combustion products of non-metallic materials 32 Annex F (informative) Rationale 37 Bibliography38 BS EN ISO 15001:2011ISO 15001:2010(E) iv ISO 2010 All rights reservedForeword ISO (the Intern

25、ational Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has b

26、een established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical sta

27、ndardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies f

28、or voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or a

29、ll such patent rights. ISO 15001 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems. This second edition cancels and replaces the first edition (ISO 15001:2003), subclauses of which have been technically revised. BS EN ISO 15

30、001:2011ISO 15001:2010(E) ISO 2010 All rights reserved vIntroduction Oxygen, pure or mixed with other medical gases, is widely used in medical applications. Because patients and clinical personnel are often in close proximity to devices used with oxygen, the risk of serious injury is high if a fire

31、occurs in an oxygen-enriched atmosphere. A common cause of fire is the heat produced by adiabatic compression, and the presence of hydrocarbon and particulate contaminants facilitates ignition. Some combustion products, especially some non-metals (e.g. plastics, elastomers and lubricants) are toxic

32、and thus patients remote from that equipment and who are receiving oxygen from a medical gas pipeline system might be injured when a problem occurs. Other equipment which is in close proximity to the equipment using oxygen, or that utilizes oxygen as its source of power, can be damaged or fail to fu

33、nction properly if there is a problem with the oxygen equipment. Reduction or avoidance of these risks depends on the choice of appropriate materials, cleaning procedures and correct design and construction of equipment so that it is compatible with oxygen under the conditions of use. This Internati

34、onal Standard gives recommendations for the selection of materials and the cleaning of components made from them, for use in oxygen and oxygen-enriched atmospheres. Annex F contains rationale statements for some of the requirements of this International Standard. It is included to provide additional

35、 insight into the reasoning that led to the requirements and recommendations that have been incorporated into this International Standard. The clauses and subclauses marked with an asterisk (*) after their number have corresponding rationale contained in Annex F. It is considered that knowledge of t

36、he reasons for the requirements will not only facilitate the proper application of this International Standard, but will expedite any subsequent revisions. It is expected that particular device standards will make reference to this horizontal International Standard and may, if appropriate, strengthe

37、n these minimum requirements. Particular device standards may specify that some requirements of this International Standard may apply for medical gases other than oxygen. BS EN ISO 15001:2011BS EN ISO 15001:2011INTERNATIONAL STANDARD ISO 15001:2010(E) ISO 2010 All rights reserved 1Anaesthetic and re

38、spiratory equipment Compatibility with oxygen 1* Scope This International Standard specifies requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications, which can come into contact with oxygen in normal condition or in single fault con

39、dition at gas pressures greater than 50 kPa. Additionally, this International Standard gives general guidelines for the selection of materials and components based on available data on their oxygen compatibility, and for carrying out a risk analysis, including addressing the toxicity of products of

40、combustion and/or decomposition. Aspects of compatibility that are addressed by this International Standard include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages. This International St

41、andard does not apply to biocompatibility. This International Standard is applicable to anaesthetic and respiratory equipment that is within the scope of ISO/TC 121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devi

42、ces, anaesthetic workstations and lung ventilators. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including

43、 any amendments) applies. ISO 14971, Medical devices Application of risk management to medical devices 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 adiabatic compression compression process that occurs without transfer of heat into or out

44、of a system 3.2 auto-ignition temperature temperature at which a material will spontaneously ignite under specified conditions BS EN ISO 15001:2011ISO 15001:2010(E) 2 ISO 2010 All rights reserved3.3 lethal concentration LC50concentration of a gas (or a gas mixture) in air, administered by a single e

45、xposure during a short period of time (24 h or less) to a group of young adult albino rats (males and females) which leads to the death of half of the animals in at least 14 d ISO 10298:2010, definition 3.1 3.4 oxygen index minimum concentration of oxygen by volume percentage in a mixture of oxygen

46、and nitrogen introduced at (23 2) C that will just support combustion of a material under specified test conditions ISO 4589-2:1996, definition 3.1 3.5 qualified technical person person who by virtue of education, training or experience knows how to apply physical and chemical principles involved in

47、 the reactions between oxygen and other materials 3.6 single fault condition condition in which a single means for reducing a risk is defective or a single abnormal condition is present IEC 60601-1:2009, definition 3.116 3.7 threshold limit value TLV concentration in air to which nearly all workers

48、may be exposed during an 8 h working day and a 40 h working week without adverse effect according to the current knowledge 3.8 oxygen-enriched mixture mixture that contains more than 23,5 % volume fraction of oxygen 4 Cleanliness 4.1* Unless otherwise specified in particular device standards, surfac

49、es of components that come into contact with oxygen during normal operation or single fault condition shall: a)* for applications in the pressure range of 50 kPa to 3 000 kPa, not have a level of hydrocarbon contamination greater than 550 mg/m2. The manufacturer shall determine and ensure that the level of particle contamination is suitable for the intended application(s); b)* for applications at pressures greater than 3 000 kPa: not have a level of hydrocarbon contamination greater than 220 mg/m2; not have particles of size great