1、BSI Standards PublicationBS EN ISO 8638:2014Cardiovascular implantsand extracorporeal systems Extracorporeal bloodcircuit for haemodialysers,haemodiafilters andhaemofiltersBS EN ISO 8638:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 8638:2014. It is i
2、dentical to ISO 8638:2010. Together with BS EN ISO 8637:2014 it supersedes BS EN 1283:1996, which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery, to Subcommittee CH/150/2, Cardiovascular implants.A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 represen
3、ted 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 correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014ISBN 978 0 5
4、80 82489 0ICS 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 affectedEUROPEAN STA
5、NDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8638 January 2014 ICS 11.040.40 English Version Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010) Implants cardiovasculaires et systmes extracorporels - C
6、ircuit sanguin extracorporel pour les hmodialyseurs, les hmodiafiltres et les hmofiltres (ISO 8638:2010) Kardiovaskulre Implantate und extrakorporale Systeme - Extrakorporaler Blutkreislauf bei Hmodialysatoren, Hmodiafiltern und Hmofiltern (ISO 8638:2010) This European Standard was approved by CEN o
7、n 1 December 2013. 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 standards m
8、ay 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 and notified
9、 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Icelan
10、d, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, 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 Managem
11、ent 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 Members. Ref. No. EN ISO 8638:2014 EBS EN ISO 8638:2014EN ISO 8638:2014 (E) 3 Foreword The text of ISO 8638:2010 has been prepared by Technical Committee
12、 ISO/TC 150 “Implants for surgery” of the International Organisation for Standardization (ISO) and has been taken over as EN ISO 8638:2014 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 nat
13、ional 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 of the elements of this document may be the subject of patent ri
14、ghts. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 1283:1986. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential require
15、ments of EU Directive(s). For relationship with EU Directive(s), 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: Aus
16、tria, 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, Portugal, Romania, Slovakia, Slovenia, Spain, Swed
17、en, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8638:2010 has been approved by CEN as EN ISO 8638:2014 without any modification. BS EN ISO 8638:2014EN ISO 8638:2014 (E) 3 Foreword The text of ISO 8638:2010 has been prepared by Technical Committee ISO/TC 150 “Implan
18、ts for surgery” of the International Organisation for Standardization (ISO) and has been taken over as EN ISO 8638:2014 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, eit
19、her 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 of the elements of this document may be the subject of patent rights. CEN and/or CE
20、NELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 1283:1986. 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 Directi
21、ve(s). For relationship with EU Directive(s), 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, Bulg
22、aria, 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, Switzerland, Tu
23、rkey and the United Kingdom. Endorsement notice The text of ISO 8638:2010 has been approved by CEN as EN ISO 8638:2014 without any modification. BS EN ISO 8638:2014EN ISO 8638:2014 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive
24、 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 Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this stan
25、dard 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 c
26、onformity 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 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualif
27、ying remarks/Notes 4.1, 4.2, 4.3 7.2 4.1 7.3 4.1, 6.3(q) 7.5 Addressed only in general terms. Although these devices can incorporate materials containing phthalates, there is no specific requirement that the presence of phthalates be indicated in the labelling. 4.4.1, 4.4.9 7.6 4.2, 4.4.1, 4.4.6, 4.
28、4.9, 6.2(e), 6.2(j), 6.4(f), 6.4(i), 6.4(n) 8.1 4.2, 5.3 8.3 Addressed only in general terms. 4.2, 5.3 8.4 4.4.2, 4.4.3, 4.4.4, 4.4.9.2 9.1 Connectors are specified to match tubing connectors specified in ISO 8637 for the blood compartment. 4.4.6.1, 4.4.10, 4.6 9.2 6 13.1 6.1, 6.2, 6.3, 6.4 13.2 The
29、 NOTE at the end of each clause allows the use of symbols from Harmonized Standards. 6.2(a), 6.3(a), 6.3(b), 6.4(a) 13.3 (a) 6.2(b), 6.2(c), 6.3(c), 6.3(d), 6.4(b), 6.4(c) 13.3 (b) 6.2(e), 6.3(f), 6.4(d) 13.3 (c) BS EN ISO 8638:2014EN ISO 8638:2014 (E) 5 Clause(s)/sub-clause(s) of this EN Essential
30、Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.2(d), 6.3(e) 13.3 (d) 6.2(f), 6.3(g) 13.3 (e) 6.2(g), 6.4(e) 13.3 (f) 6.3(h) 13.3 (i) 6.2(j), 6.4(g), 6.4(i), 6.4(l), 6.4(m), 6.4(o) 13.3 (j) 6.2(j), 6.4(f) 13.3 (k) 6.2(i) 13.3 (m) 6.4(a), 6.4(b), 6.4(c), 6.4(d), 6.4(e), 6.4(f), 6
31、.4(g), 6.4(i), 6.4(l), 6.4(m), 6.4(o) 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(r) 13.6 (c) WARNING Other requirements and other EU Directives
32、may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 8638:2014EN ISO 8638:2014 (E) 5 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.2(d), 6.3(e) 13.3 (d) 6.2(f), 6.3(g) 13.3 (e) 6.2(g), 6.4(e) 13.3
33、 (f) 6.3(h) 13.3 (i) 6.2(j), 6.4(g), 6.4(i), 6.4(l), 6.4(m), 6.4(o) 13.3 (j) 6.2(j), 6.4(f) 13.3 (k) 6.2(i) 13.3 (m) 6.4(a), 6.4(b), 6.4(c), 6.4(d), 6.4(e), 6.4(f), 6.4(g), 6.4(i), 6.4(l), 6.4(m), 6.4(o) 13.6 (a) There is no requirement for the information in 13.3(i) in the instructions for use. Ins
34、tead, that information is required to be given on the outer container in which the device is sold. 6.4(r) 13.6 (c) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 8638:2014ISO 8638:2010(E) ISO 2010 All rights
35、 reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .2 4 Requirements.2 4.1 Biological safety 2 4.2 Sterility3 4.3 Non-pyrogenicity .3 4.4 Mechanical characteristics.3 4.5 Expiry date .5 4.6 Tubing compliance5 5 Test methods .5 5.1 General .
36、5 5.2 Biological safety 6 5.3 Sterility6 5.4 Non-pyrogenicity .6 5.5 Mechanical characteristics.6 5.6 Expiry date .9 5.7 Tubing compliance9 6 Labelling.10 6.1 Labelling on the device.10 6.2 Labelling on the unit container 10 6.3 Labelling on the outer container10 6.4 Accompanying documentation11 Bib
37、liography13 BS EN ISO 8638:2014ISO 8638:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International 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 I
38、SO technical committees. Each member body interested in a subject for which a technical committee has been 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
39、closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 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.
40、Draft International Standards adopted by the technical committees are circulated to the member bodies for 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 d
41、ocument may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8638 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems. This third edition cance
42、ls and replaces the second edition (ISO 8638:2004), which has been technically revised. BS EN ISO 8638:2014ISO 8638:2010(E) ISO 2010 All rights reserved vIntroduction This International Standard is concerned with the extracorporeal blood circuit manufactured for single use and intended for use in co
43、njunction with haemodialysers, haemodiafilters and haemofilters. The requirements specified in this International Standard for the extracorporeal blood circuit will help to ensure safety and satisfactory function. It was not found practicable to specify materials of construction. This International
44、Standard therefore requires only that materials have been tested and that the methods and results are made available upon request. The dimensions of the connectors intended for connecting the extracorporeal blood circuit to a haemodialyser, haemodiafilter or haemofilter have been specified to ensure
45、 compatibility with these devices, as specified in ISO 8637. The design and dimensions have been selected in order to minimize the risk of leakage of blood and ingress of air. Connectors with either fixed or loose locking shells are permitted. This International Standard reflects the consensus of ph
46、ysicians, manufacturers and other interested parties for devices that are approved for clinical use. Conformance with this International Standard is voluntary and it is not intended to supersede any national regulation. BS EN ISO 8638:2014BS EN ISO 8638:2014INTERNATIONAL STANDARD ISO 8638:2010(E) IS
47、O 2010 All rights reserved 1Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters 1 Scope This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereaf
48、ter referred to as “the device”) and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. This International Standard does not apply to: haemodialysers, haemodiafilters or haemofilters; plasmafilters; haemoperfusion de
49、vices; vascular access devices; blood pumps; pressure monitors for the extracorporeal blood circuit; air detection devices; systems to prepare, maintain or monitor dialysis fluid; systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637. 2 Normative references The following referenced documents are indispensable for the application of
