EN ISO 7199-2017 en Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)《心血管植入物和人工器官血液气体交换器(器)(ISO 7199 2016)》.pdf

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1、BS EN ISO 7199:2017Cardiovascular implants andartificial organs Blood-gasexchangers (oxygenators) (ISO7199:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 7199:2017 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN I

2、SO 7199:2017. It is identical to ISO 7199:2016. It supersedes BS EN ISO 7199:2014 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150/2, Cardiovascular implants.A list of organizations represented on this committee can be obtained on request to its

3、secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017. Published by BSI Standards Limited 2017ISBN 978 0 580 89932 4 ICS 11.040.40 Compliance with a British Standard

4、 cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2017.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7199 Janua

5、ry 2017 ICS 11.040.40 Supersedes EN ISO 7199:2014English Version Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016) Implants cardiovasculaires et organes artificiels - changeurs gaz/sang extracorporels (oxygnateurs) (ISO 7199:2016) Kardiovaskulre Impla

6、ntate und knstliche Organe - Blutgasaustauscher (Oxygenatoren) (ISO 7199:2016)This European Standard was approved by CEN on 6 November 2016. 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 nati

7、onal 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 Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A ver

8、sion 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 the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus,

9、Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United

10、 Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN IS

11、O 7199:2017 EBS EN ISO 7199:2017EN ISO 7199:2017 (E) 3 European foreword This document (EN ISO 7199:2017) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by D

12、IN. 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 by July 2017, and conflicting national standards shall be withdrawn at the latest by July 2017. Attention is drawn to the possibility that some of

13、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 patent rights. This document supersedes EN ISO 7199:2014. This document has been prepared under a mandate given to CEN by the European Commission and th

14、e European Free Trade Association, and supports essential requirements 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 c

15、ountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

16、 Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendment

17、s) applies. For dated references, only the edition cited applies. However, for any use of this standard “within the meaning of Annex ZA“, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledge

18、d state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below. NOTE The way in which these reference

19、d documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. BS EN ISO 7199:2017EN ISO 7199:2017 (E) 4 Table Correlations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO stan

20、dard Equivalent dated standard EN ISO ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 and Amd 1:2006 ISO 10993-7 EN ISO 10993-7:2008 and EN ISO 10993-7:2008/AC:2009 ISO 10993-7:2008 and ISO 10993-7:1/Cor 1:2009 ISO 10993-11 EN ISO 10993-11:2009 ISO 1

21、0993-11:2006 ISO 11135 EN ISO 11135:2014 ISO 11135:2014 ISO 11137-1 EN ISO 11137-1:2006 and EN ISO 11137-1:2006/A1:2013 ISO 11137-1:2006 and Amd 1:2013 ISO 11607-1 EN ISO 11607-1:2009 and EN ISO 11607-1:2009/A1:2014 ISO 11607-1:2006 and Amd 1:2014 ISO 11607-2 EN ISO 11607-2:2006 and EN ISO 11607-2:2

22、006/A1:2014 ISO 11607-2:2006 and Amd 1:2014 ISO 15675 ISO 15675:2009 ISO 17665-1 EN ISO 17665-1:2006 ISO 17665-1:2006 Endorsement notice The text of ISO 7199:2016 has been approved by CEN as EN ISO 7199:2017 without any modification. BS EN ISO 7199:2017EN ISO 7199:2017 (E) 5 Annex ZA (informative) R

23、elationship between this European standard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions standardization request M/023 concerning the development of European standards related to medical devices to prov

24、ide a voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of this standard giv

25、en 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 regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the

26、 risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced “as far as possible“, “to a minimum“, “to the lowest possible level“, “minimized“ or “removed“, according to the wording of the corresponding essential requi

27、rement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing th

28、e references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements (ERs) of Directi

29、ve 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 7.2 4.1.1; 4.1.2; 5.2; 5.2.1; 5.2.2; 5.3; 5.3.1; 5.3.1.1; 5.3.1.2; 5.3.2; 5.3.2.1; 5.3.2.2; 6.2.1 d); 6.2.2 d); 6.3 u) 1) 4.1.1 and 4.1.2 address manufacturers requirements to ensure product sterility, non-pyrogenicity, and biocompatibili

30、ty. 5.2 and 5.3 with associated sub-clauses address testing for the above to verify compliance that products are sterile, non-pyrogenic, and biocompatible. 6.2.1, 6.2.2 and 6.3 with associated sub-clauses address labelling to include the manufacturers documentation attesting to BS EN ISO 7199:2017EN

31、 ISO 7199:2017 (E) 6 the above, which are to be supplied on the unit container, shipping container, and accompanying product literature, including Instructions for Use. 7.3 4.3.6; 4.3.6.1; 4.3.6.2; 5.2; 5.2.1; 5.2.2; 5.4.3; 5.4.3.1; 5.4.3.2 4.3.6 with associated sub-clauses address blood cell damage

32、 when the product is used for its intended purpose. 5.2 with associated sub-clauses address biological characteristics and manufacturers compliance for verification regarding sterility, non-pyrogenicity and biocompatibility. 5.4.3 with associated sub-clauses describe specific testing parameters for

33、documenting blood cell damage. The second part of ER 7.3 relating to medicinal products is not covered. 7.5 4.2.1; 4.2.2; 4.2.4 4.2.1 and 4.2.2 address minimizing the risk of leakage by the requirement that blood pathways (e.g. oxygenator, heat exchanger) do not leak. 4.2.4 addresses the requirement

34、 that connectors used for connections to the blood pathways must be secure, which also addresses the minimization of risk of leakage. Only the first sentence of ER 7.5 is covered. 8.1 4.1.1; 4.1.2; 6.2.1 d); 6.2.2 d); 6.3 u) 1) 4.1.1 and 4.1.2 require products to be sterile, non-pyrogenetic, and bio

35、compatible. 6.2.1, 6.2.2, and 6.3 with associated sub-clauses address sterilization information to be supplied on labelling for the units, shipping containers, and in the accompanying Instructions for Use. Only the first sentence of ER BS EN ISO 7199:2017EN ISO 7199:2017 (E) 7 8.1 is covered. 9.1 4.

36、2.4 4.2.4 addresses manufacturers requirements that connectors provide for secure connection of additional products for assembly into a system for its intended use. 4.2.4 covers ER 9.1 in respect of blood pathway connections only. 13.1 6.1 a); 6.2.1 a) h); 6.2.2 a); 6.3 a) 6.1, 6.2 and 6.3 with asso

37、ciated sub-clauses address the manufacturers identification, Instructions for Use for the safe use of the product and any special handling or storage conditions. 13.1, first paragraph, last five words only are covered by 6.1 a), 6.2.1 a), 6.2.2 a) and 6.3 a) only. 13.2 6.2.1 g) i) Clause 6.2.1 with

38、associated sub-clauses address use of approved symbols on the unit container. 13.2 is covered only is respect of Read Instructions for use and Single use only. 13.3 a) 6.2.1 a), 6.2.2 a) and 6.3 a) The standard does not address a requirement regarding an authorised representative when the manufactur

39、er does not have a registered place of business in the Community. ER 13.3 a) is covered by 6.2.1 a), 6.2.2 a) and 6.3 a) but only in respect of manufacturer. 13.3 b) 6.2.1 b)-c); 6.2.2 b)-c); 6.3 b) 6.2.1, 6.2.2 and 6.3 with associated sub-clauses address identification of the device and contents of

40、 the packaging. 13.3 c) 6.2.1 d); 6.2.2 d) 6.2.1 and 6.2.2 with associated sub-clauses address designation of the sterility of the product on the BS EN ISO 7199:2017EN ISO 7199:2017 (E) 8 unit and shipping containers and in the Instructions for Use. 13.3 d) 6.2.1 f) 6.2.1 with the associated sub-cla

41、use address product batch, lot or serial number designations. ER 13.3 d) is only met if the batch code is preceded by the word LOT. 13.3 e) 6.2.2 e) 6.2.2 with the associated sub-clause address expiry date on the unit container. ER 13.3 e) is only met if the expiry date is given as a year and month.

42、 13.3 f) 6.2.1 i) 6.2.1 with the associated sub-clause address one-time (single) use of the device. 13.3 i) 6.2.1 h); 6.2.2 f) 6.2.1 and 6.2.2 with associated sub-clauses address labelling on the unit and shipping containers regarding any special handling or storage conditions. 13.3 j) 6.3 d) 6.3 an

43、d 6.4 with associated sub-clauses address special or unique procedures and limitations during use in accompanying documents. ER 13.3 j) is covered by 6.3 d) only in respect of the Instructions for Use. 13.3 k) 6.2.1 g) 6.2.1 with the associated sub-clause address Instructions for Use containing warn

44、ings and precautions. ER 13.3 k) is covered by 6.2.1 g) only in respect of the unitcontainer. 13.4 6.2.1 g); 6.3 6.2.1 with the associated sub-clause and 6.3 address Instructions for Use labelling on the unit container and in accompanying documents supplied with the product. BS EN ISO 7199:2017EN IS

45、O 7199:2017 (E) 9 13.6 c) 6.3 e)-g) 6.3 with associated sub-clauses address mounting and connection of device components for safe use. ER 13.6 c) is covered only to the extent shown in 6.3 e)-g). 13.6 i) 6.3 e) f) The standard addresses sterile products that do not require further treatment before u

46、se. 6.3 with associated sub-clauses address mounting of the device and assembly with other products before use. ER 13.6 i) is covered only to the extent shown in 6.3 e)-f). 13.6 p) 4.2.3 4.2.3 addresses testing of volumetric measurements and tolerances specified by the manufacturer. ER 13.6 p) is on

47、ly covered for blood volumes only and only when the degree of accuracy is given in the Instructions for Use. WARNING 1: Presumption of conformity stays valid only as long as a reference to this European standard is maintained in the list published in the Official Journal of the European Union. Users

48、 of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 7199:2017ISO 7199:2016(E)Foreword ivIntroduction v1 Scope .

49、 12 Normative references 13 Terms and definitions . 24 Requirements 34.1 Biological characteristics . 34.1.1 Sterility and non-pyrogenicity . 34.1.2 Biocompatibility . 34.2 Physical characteristics . 44.2.1 Blood pathway integrity 44.2.2 Heat exchanger fluid pathway integrity . 44.2.3 Blood volumes 44.2.4 Connectors 44.3 Performance characteristics 44.3.1 Oxygen and carbon dioxide transfer rates . 44.3.2 Heat exchanger performance factor 44.3.3 Integral arterial filtration efficiency 44.3.4 Integral arterial filter flow rate capacit