1、BSI Standards PublicationBS EN ISO 8637:2014Cardiovascular implantsand extracorporeal systems Haemodialysers,haemodiafilters, haemofiltersand haemoconcentrators(ISO 8637:2010, includingAmendment 1 2013-04-01)Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolle
2、d Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 8637:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 8637:2014. It is identical to ISO 8637:2010, incorporating amendment 1:2013. Together with BS EN ISO
3、 8368:2014, it supersedes BS EN 1283:1996, which is withdrawn.ISO amendment 1:2013 updates Figure 2.The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery, to Subcommittee CH/150/2, Cardiovascular implants.A list of organizations represented on this
4、 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 correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 82488 3I
5、CS 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 Strategy Committee on 31 March 2014.Amendments/corrigenda issued since publicationDate Text affectedCopyright British Stand
6、ards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8637 January 2014 ICS 11.040.40 English Version Cardiovascular implants and extracor
7、poreal systems - Haemodialysers, haemodiafilters, haemofilters and 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)
8、 Kardiovaskulre Implantate und extrakorporale Systeme - Hmodialysatoren, 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 Regu
9、lations 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 Centre or to any CEN memb
10、er. 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 the official versions. C
11、EN members are the national standards bodies of 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, Poland,
12、 Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, 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
13、any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8637:2014 ECopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 8637:2014E
14、N 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 over as EN ISO 8637:2014 by Technical Committee CEN/TC
15、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 conflicting national standards shall be withdrawn at the la
16、test 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 supersedes EN 1283:1996. According to the CEN-CENELEC
17、 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 of Macedonia, France, Germany, Greece, Hungary, Icela
18、nd, 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 approved by CEN as EN ISO 8637:2014 without any modification.
19、 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) and has been taken over as EN ISO 8637:2014 by Techni
20、cal 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 conflicting national standards shall b
21、e 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 supersedes EN 1283:1996. Accordi
22、ng 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 of Macedonia, France, Germany, G
23、reece, 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 approved by CEN as EN ISO 8637:2014 with
24、out 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 prepared under a mandate given to CEN by the European Commiss
25、ion 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 that Directive and has been implemented as a national sta
26、ndard 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 Corre
27、spondence 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 Addressed only in general terms. Blood-contacting surfaces in
28、corporating 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), 6.2(h), 6.3(f), 6.3(g), 6.4(c), 6.4(f), 6.4(g), 6.4(
29、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 NOTE at the end of each clause allows the use of symbo
30、ls from Harmonized Standards. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 8637:2014EN ISO 8637:2014 (E) 3 Foreword The text of ISO 8637:2010, including
31、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 over as EN ISO 8637:2014 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by
32、 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 conflicting national standards shall be withdrawn at the latest by July 2014. Attention is drawn to the possibility that some o
33、f 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 1283:1996. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the f
34、ollowing countries 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, Netherland
35、s, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the 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) 4 Annex ZA (informative) Re
36、lationship 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 Essential
37、 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
38、 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 this European Standard and Directive 93/42/EEC on medical devices (1 of
39、 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 Addressed only in general terms. Blood-contacting surfaces incorporating medicinalproducts, such as heparin, are not specifically addressed. 4.1, 6.4(
40、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), 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.
41、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 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
42、 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 over as EN ISO 8637:2014 by Technical Committee CEN/TC 205 “Non-active medical devices” the se
43、cretariat 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 conflicting national standards shall be withdrawn at the latest by July 2014. Attention is drawn t
44、o 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 supersedes EN 1283:1996. According to the CEN-CENELEC Internal Regulations, the national sta
45、ndards 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 of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
46、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 approved by CEN as EN ISO 8637:2014 without any modification. Copyright British Standards Institutio
47、n Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-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 Qualify
48、ing remarks/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.
49、4(i) 13.3 (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 device 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
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