1、June 2012 Translation by DIN-Sprachendienst.English price group 19No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 1
2、1.040.10!$|“1896195www.din.deDDIN EN ISO 15001Anaesthetic and respiratory equipment Compatibility with oxygen (ISO 15001:2010)English translation of DIN EN ISO 15001:2012-06Ansthesie- und Beatmungsgerte Vertrglichkeit mit Sauerstoff (ISO 15001:2010)Englische bersetzung von DIN EN ISO 15001:2012-06Ma
3、triel danesthsie et de ranimation respiratoire Compatibilit avec loxygne (ISO 15001:2010)Traduction anglaise de DIN EN ISO 15001:2012-06SupersedesDIN EN ISO 15001:2010-11www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.4905.12 DIN E
4、N ISO 15001:2012-06 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipmen
5、t” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Working Committee NA 053-03-06 AA Zentrale Gasversorgungsanlagen. The DIN Standards corresponding
6、to the International Standards referred to in this document are as follows: ISO 4135 DIN EN ISO 4135 ISO 4589-1 DIN EN ISO 4589-1 ISO 4589-2 DIN EN ISO 4589-2 ISO 4589-3 DIN EN ISO 4589-3 ISO 7291 DIN EN ISO 7291 ISO 11114-1 DIN EN ISO 11114-1 ISO 11114-3 DIN EN ISO 11114-3 ISO 14971 DIN EN ISO 1497
7、1 Amendments This standard differs from DIN EN ISO 15001:2004-08 as follows: a) in Clause 1 “Scope” it has been clarified that this standard does not apply to biocompatibility; b) in Subclause 4.1 it has been specified that surfaces of components that come into contact with oxygen during normal oper
8、ation or single fault condition are not to have particles sizes greater than 100 m for applications at pressures greater than 3 000 kPa; c) in Subclause 4.3 it has been specified that cleaning compounds and methods are to be compatible with the materials, components and devices to be cleaned; d) the
9、 requirements relating to risk management have been revised; e) the standard has been editorially revised. This standard differs from DIN EN ISO 15001:2010-11 as follows: Annex ZA “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC” has been rendered
10、 more precise. Previous editions DIN EN ISO 15001: 2004-08, 2010-11 DIN EN ISO 15001:2012-06 3 National Annex NA (informative) Bibliography DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 4589-1, Plastics Determination of burning behaviour by oxygen index Part 1: Guidanc
11、e DIN EN ISO 4589-2, Plastics Determination of burning behaviour by oxygen index Part 2: Ambient-temperature test DIN EN ISO 4589-3, Plastics Determination of burning behaviour by oxygen index Part 3: Elevated-temperature test DIN EN ISO 11114-1, Transportable gas cylinders Compatibility of cylinder
12、 and valve materials with gas contents Part 1: Metallic materials DIN EN ISO 11114-3, Transportable gas cylinders Compatibility of cylinder and valve materials with gas contents Part 3: Autogenous ignition test for non-metallic materials in oxygen atmosphere DIN EN ISO 14971, Medical devices Applica
13、tion of risk management to medical devices DIN EN ISO 15001:2012-06 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15001 October 2011 ICS 11.040.40 Supersedes EN ISO 15001:2010English Version Anaesthetic and respiratory equipment - Compatibility with oxyg
14、en (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 approved by CEN on 20 September 2011. CEN members are bound to comply with the C
15、EN/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 standards may be obtained on application to the CEN-CENELEC Management C
16、entre 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 and notified to the CEN-CENELEC Management Centre has the same status as
17、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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Roma
18、nia, 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 2011 CEN All rights of exploitation in any form and by any means reserved
19、worldwide for CEN national Members. Ref. No. EN ISO 15001:2011: EContents DIN EN ISO 15001:2012-06 EN ISO 15001:2011 (E) 2 PageForeword 3 Introduction .4 1* Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Cleanliness .6 5* Resistance to ignition .7 6 Risk management 7 Annex A (informat
20、ive) Examples of cleaning procedures .8 Annex B (informative) Typical methods for validation of cleaning procedures .15 Annex C (informative) Design considerations .18 Annex D (informative) Selection of materials .23 Annex E (informative) Recommended method for combustion and quantitative analysis o
21、f combustion products of non-metallic materials 36 Annex F (informative) Rationale 41 Bibliography 42 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC .45 Foreword This document (EN ISO 15001:2011) has been prepared by Techni
22、cal Committee ISO/TC 121 Anaesthetic and respiratory 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 i
23、dentical text or by endorsement, at the latest 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
24、responsible for identifying any or all such patent 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 req
25、uirements of EU Directive. For relationship with 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: Austr
26、ia, Belgium, Bulgaria, Croatia, 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 the United Kingdom. E
27、ndorsement notice The text of ISO 15001:2010 has been approved by CEN as EN ISO 15001:2011 without any modification. “DIN EN ISO 15001:2012-06 EN ISO 15001:2011 (E) 3 Introduction Oxygen, pure or mixed with other medical gases, is widely used in medical applications. Because patients and clinical pe
28、rsonnel are often in close proximity to devices used with oxygen, the risk of serious injury is high if a fire 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 ignit
29、ion. Some combustion products, especially some non-metals (e.g. plastics, elastomers and lubricants) are toxic 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 proxim
30、ity to the equipment using oxygen, or that utilizes oxygen as its source of power, can be damaged or fail to function 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
31、 and construction of equipment so that it is compatible with oxygen under the conditions of use. This International 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 rationa
32、le statements for some of the requirements of this International Standard. It is included to provide additional 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
33、 (*) after their number have corresponding rationale contained in Annex F. It is considered that knowledge of the 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 de
34、vice standards will make reference to this horizontal International Standard and may, if appropriate, strengthen these minimum requirements. Particular device standards may specify that some requirements of this International Standard may apply for medical gases other than oxygen. DIN EN ISO 15001:2
35、012-06 EN ISO 15001:2011 (E) 4 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 condition at gas p
36、ressures 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 combustion and/
37、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 Standard does not
38、 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 devices, anaestheti
39、c 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 any amendments
40、) 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 of a system 3.2
41、 auto-ignition temperature temperature at which a material will spontaneously ignite under specified conditions DIN EN ISO 15001:2012-06 EN ISO 15001:2011 (E) 5 3.3 lethal concentration LC50concentration of a gas (or a gas mixture) in air, administered by a single exposure during a short period of t
42、ime (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 and nitrogen introduced at (23 2)
43、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 the reactions between oxygen and
44、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 may be exposed during an 8 h worki
45、ng 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, surfaces of components that come into co
46、ntact 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
47、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 greater than 100 m. These requirements shall be met either by an appropriate method of manufacture or b
48、y use of an appropriate cleaning procedure. Compliance shall be checked either by verification of the cleanliness of the components or by validation of the cleaning procedure or the manufacturing process. DIN EN ISO 15001:2012-06 EN ISO 15001:2011 (E) 6 This International Standard does not specify quantifiable cleaning procedures or validation methods for them in relation to the values in a) and b) above. However, Annex A gives examples of known cleaning procedures and Annex B gives example
