1、BSI Standards PublicationBS EN ISO 8637:2014Cardiovascular implantsand extracorporeal systems Haemodialysers,haemodiafilters, haemofiltersand haemoconcentrators(ISO 8637:2010, includingAmendment 1 2013-04-01)BS EN ISO 8637:2014 BRITISH STANDARDNational forewordThis British Standard is the UK impleme
2、ntation of EN ISO 8637:2014. It is identical to ISO 8637:2010, incorporating amendment 1:2013. Together with BS EN ISO 8368:2014, it supersedes BS EN 1283:1996, which is withdrawn.ISO amendment 1:2013 updates Figure 2.The UK participation in its preparation was entrusted by Technical Committee CH/15
3、0, Implants for surgery, to Subcommittee CH/150/2, Cardiovascular implants.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its corre
4、ct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 82488 3ICS 11.040.40Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strat
5、egy Committee on 31 March 2014.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8637 January 2014 ICS 11.040.40 English Version Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters a
6、nd haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01) Implants cardiovasculaires et systmes extracorporels - Hmodialyseurs, hmodiafiltres, hmofiltres et hmoconcentrateurs (ISO 8637:2010, Amendement 1 2013-04-01 inclus) Kardiovaskulre Implantate und extrakorporale Systeme - Hmodialy
7、satoren, Hmodiafilter, Hmofilter und Hmokonzentratoren (ISO 8637:2010, einschlielich nderung 1 2013-04-01) This European Standard was approved by CEN on 1 December 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
8、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 Centre or to any CEN member. This European Standard exists in three official versions (En
9、glish, 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 the official versions. CEN members are the national standards bodies of Austria, Belgium
10、, 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, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerla
11、nd, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Me
12、mbers. Ref. No. EN ISO 8637:2014 EBS EN ISO 8637:2014EN ISO 8637:2014 (E) 3 Foreword The text of ISO 8637:2010, including Amendment 1 2013-04-01 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organisation for Standardization (ISO) and has been taken o
13、ver as EN ISO 8637:2014 by Technical Committee CEN/TC 205 “Non-active medical devices” 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 endorsement, at the latest by July 2014, and confl
14、icting national standards shall be withdrawn at the latest by July 2014. 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 patent rights. This document
15、 supersedes EN 1283:1996. 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 Republic, Denmark, Estonia, Finland, Former Yugoslav Republic
16、 of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8637:2010 has been approve
17、d by CEN as EN ISO 8637:2014 without any modification. BS EN ISO 8637:2014EN ISO 8637:2014 (E) 3 Foreword The text of ISO 8637:2010, including Amendment 1 2013-04-01 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organisation for Standardization (ISO)
18、 and has been taken over as EN ISO 8637:2014 by Technical Committee CEN/TC 205 “Non-active medical devices” 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 endorsement, at the latest by
19、 July 2014, and conflicting national standards shall be withdrawn at the latest by July 2014. 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 patent
20、rights. This document supersedes EN 1283:1996. 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 Republic, Denmark, Estonia, Finland, For
21、mer Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8637:
22、2010 has been approved by CEN as EN ISO 8637:2014 without any modification. BS EN ISO 8637:2014EN ISO 8637:2014 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepare
23、d under a mandate given 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 on medical devices. Once this standard is cited in the Official Journal of the European Union under tha
24、t Directive and has been implemented 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 Direc
25、tive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices (1 of 2) Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4.1, 4.2, 4.3 7.2 4.1 7.3 4.1 7.4 Address
26、ed only in general terms. Blood-contacting surfaces incorporating medicinalproducts, such as heparin, are not specifically addressed. 4.1, 6.4(n) 7.5 Addressed only in general terms. Typically, these devices do not incorporate materials containing phthalates. 4.2, 4.3, 6.1(h), 6.1(i), 6.2(e), 6.2(f)
27、, 6.2(h), 6.3(f), 6.3(g), 6.4(c), 6.4(f), 6.4(g), 6.4(i) 8.1 4.2, 5.3 8.3 Addressed only in general terms. 4.2, 5.3 8.4 4.4.3, 4.4.4, 4.4.5, 4.4.6 9.1 Connectors are specified to match tubing connectors specified in ISO 8638 for the blood compartment. 4.4.4 12.7.4 6 13.1 6.1, 6.2, 6.3, 6.4 13.2 The
28、NOTE at the end of each clause allows the use of symbols from Harmonized Standards. BS EN ISO 8637:2014EN ISO 8637:2014 (E) 3 Foreword The text of ISO 8637:2010, including Amendment 1 2013-04-01 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organisat
29、ion for Standardization (ISO) and has been taken over as EN ISO 8637:2014 by Technical Committee CEN/TC 205 “Non-active medical devices” 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
30、endorsement, at the latest by July 2014, and conflicting national standards shall be withdrawn at the latest by July 2014. 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 identi
31、fying any or all such patent rights. This document supersedes EN 1283:1996. 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 Republic, D
32、enmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement
33、 notice The text of ISO 8637:2010 has been approved by CEN as EN ISO 8637:2014 without any modification. BS EN ISO 8637:2014EN ISO 8637:2014 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This Europ
34、ean Standard has been prepared under a mandate given 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 on medical devices. Once this standard is cited in the Official Journal of
35、 the European Union under that Directive and has been implemented 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 Essenti
36、al Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices (1 of 2) Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4.1, 4.2, 4.
37、3 7.2 4.1 7.3 4.1 7.4 Addressed only in general terms. Blood-contacting surfaces incorporating medicinalproducts, such as heparin, are not specifically addressed. 4.1, 6.4(n) 7.5 Addressed only in general terms. Typically, these devices do not incorporate materials containing phthalates. 4.2, 4.3, 6
38、.1(h), 6.1(i), 6.2(e), 6.2(f), 6.2(h), 6.3(f), 6.3(g), 6.4(c), 6.4(f), 6.4(g), 6.4(i) 8.1 4.2, 5.3 8.3 Addressed only in general terms. 4.2, 5.3 8.4 4.4.3, 4.4.4, 4.4.5, 4.4.6 9.1 Connectors are specified to match tubing connectors specified in ISO 8638 for the blood compartment. 4.4.4 12.7.4 6 13.1
39、 6.1, 6.2, 6.3, 6.4 13.2 The NOTE at the end of each clause allows the use of symbols from Harmonized Standards. BS EN ISO 8637:2014EN ISO 8637:2014 (E) 3 Foreword The text of ISO 8637:2010, including Amendment 1 2013-04-01 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” o
40、f the International Organisation for Standardization (ISO) and has been taken over as EN ISO 8637:2014 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publicatio
41、n of an identical text or by endorsement, at the latest by July 2014, and conflicting national standards shall be withdrawn at the latest by July 2014. 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 b
42、e held responsible for identifying any or all such patent rights. This document supersedes EN 1283:1996. 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, Croat
43、ia, Cyprus, 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and th
44、e United Kingdom. Endorsement notice The text of ISO 8637:2010 has been approved by CEN as EN ISO 8637:2014 without any modification. BS EN ISO 8637:2014EN ISO 8637:2014 (E) 5 Table ZA.1 (2 of 2) Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remark
45、s/Notes 6.1(a), 6.2(a), 6.3(a), 6.3(b), 6.4(a) 13.3 (a) 6.1(b), 6.1(c), 6.2(b), 6.2(c), 6.3(c), 6.3(d), 6.4(b), 6.4(e) 13.3 (b) 6.2(e), 6.3(f), 6.4(f) 13.3 (c) 6.1(d), 6.2(d), 6.3(e) 13.3 (d) 6.1(g), 6.2(g), 6.3(h) 13.3 (e) 6.1(i), 6.2(h), 6.4(g) 13.3 (f) 6.3(g) 13.3 (i) 6.4(c), 6.4(d), 6.4(i) 13.3
46、(j) 6.2(j), 6.4(d) 13.3 (k) 6.1(h), 6.2(f), 6.4(f) 13.3 (m) 6.4(a), 6.4(b), 6.4(e), 6.4(f), 6.4(g), 6.4(i), 6.4(f) 13.6 (a) There is no requirement for the information in 13.3 (i) in the instructions for use. Instead, that information is required to be given on the outer container in which the devic
47、e is sold. 6.4(h) 13.6 (b) 6.4(l), 6.4(m) 13.6 (c) 6.2(h), 6.4(g), 6.4(i) 13.6 (h) 6.4(c), 6.4(d) 13.6 (i) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 8637:2014EN ISO 8637:2014 (E) 4 Annex ZA (informative
48、) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essen
49、tial Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented 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 regulations. Table ZA.1 Correspondence between thi
