1、March 2014 Translation by DIN-Sprachendienst.English price group 12No 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
2、11.040.20!%,I“2099538www.din.deDDIN EN ISO 8638Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters andhaemofilters (ISO 8638:2010);English version EN ISO 8638:2014,English translation of DIN EN ISO 8638:2014-03Kardiovaskulre Implantate
3、und extrakorporale Systeme Extrakorporaler Blutkreislauf bei Hmodialysatoren, Hmodiafiltern und Hmofiltern(ISO 8638:2010);Englische Fassung EN ISO 8638:2014,Englische bersetzung von DIN EN ISO 8638:2014-03Implants cardiovasculaires et systmes extracorporels Circuit sanguin extracorporel pourles hmod
4、ialyseurs, les hmodiafiltres et les hmofiltres (ISO 8638:2010);Version anglaise EN ISO 8638:2014,Traduction anglaise de DIN EN ISO 8638:2014-03Together with DIN EN ISO8637:2014-03,supersedesDIN EN 1283:1996-06www.beuth.deDocument comprises 23 pagesIn case of doubt, the German-language original shall
5、 be considered authoritative.03.14DIN EN ISO 8638:2014-03 2 A comma is used as the decimal marker. National foreword The text of ISO 8638:2010 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” and has been taken over as EN ISO 8638:2014 by Technical Committee CEN/TC 205 “Non
6、-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-01-03 AA Extrakorporaler Kreislauf, Apparate und Einmalartikel. The DIN Standards corresponding to the
7、 International Standards referred to in this document are as follows: ISO 7864 DIN EN ISO 7864 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-4 DIN EN ISO 10993-4 ISO 10993-7 DIN EN ISO 10993-7 ISO 10993-11 DIN EN ISO 10993-11 Amendments This standard differs from DIN EN 1283:1996-06 as follows: a) normat
8、ive references have been updated; b) Clause 3 “Terms and definitions” has been revised and extended; c) Clause 4 “Requirements” has been revised/restructured and requirements for the expiry date have been added; d) Clause 5 “Test methods” has been revised/restructured and Subclause 5.6 “Expiry date”
9、 has been added; e) the (revised) figures have been largely adopted from DIN EN 1283:1996-06; f) Clause 6 “Labelling” has been revised, extended and restructured; g) the standard has been editorially revised. Previous editions DIN 58352-1: 1982-10 DIN 13090-3: 1983-04, 1991-05 DIN 58352-2: 1983-04 D
10、IN 58353-1: 1987-07 DIN 58353-2: 1988-03 DIN 58352-3: 1988-03, 1988-06 DIN 58351-1: 1988-11 DIN 58352-4: 1989-10 DIN EN 1283: 1996-06 DIN EN ISO 8638:2014-03 3 National Annex NA (informative) Bibliography DIN EN ISO 7864, Sterile hypodermic needles for single use DIN EN ISO 10993-1, Biological evalu
11、ation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood DIN EN ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilizatio
12、n residuals DIN EN ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity DIN EN ISO 8638:2014-03 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8638 January 2014 ICS 11.040.40 Supersedes EN 1283:1996English Version Ca
13、rdiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010) Implants cardiovasculaires et systmes extracorporels - Circuit sanguin extracorporel pour les hmodialyseurs, les hmodiafiltres et les hmofiltres (ISO 8
14、638:2010) Kardiovaskulre Implantate und extrakorporale Systeme - Extrakorporaler Blutkreislauf bei Hmodialysatoren, Hmodiafiltern und Hmofiltern (ISO 8638:2010) This European Standard was approved by CEN on 1 December 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations wh
15、ich 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 member. This E
16、uropean 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. CEN members
17、 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, Portugal,
18、 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 any form a
19、nd by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8638:2014 EContents Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .6 4 Requirements.6 4.1 Biological safety 6 4.2 Sterility7 4.3 Non-pyrogenicity .7 4.4 Mechanical characteristics.
20、7 4.5 Expiry date .9 4.6 Tubing compliance9 5 Test methods .9 5.1 General .9 5.2 Biological safety 10 5.3 Sterility10 5.4 Non-pyrogenicity .10 5.5 Mechanical characteristics.10 5.6 Expiry date .13 5.7 Tubing compliance13 6 Labelling.14 6.1 Labelling on the device.14 6.2 Labelling on the unit contain
21、er 14 6.3 Labelling on the outer container14 6.4 Accompanying documentation15Bibliography19Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 17DIN EN ISO 8638:2014-03 EN ISO 8638:2014 (E) 2 Foreword The text
22、 of ISO 8638:2010 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 8638:2014 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
23、 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 of the
24、 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 1283:1986. This document has been prepared under a mandate given to CEN by the European Commission and the Europ
25、ean Free Trade Association, and supports essential requirements 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 co
26、untries 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,
27、Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, 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. DIN EN ISO 8638:2014-03 EN ISO 8638:2014 (E) 3 Introduction This International
28、 Standard is concerned with the extracorporeal blood circuit manufactured for single use and intended for use in conjunction with haemodialysers, haemodiafilters and haemofilters. The requirements specified in this International Standard for the extracorporeal blood circuit will help to ensure safet
29、y and satisfactory function. It was not found practicable to specify materials of construction. This International 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 connecti
30、ng the extracorporeal blood circuit to a haemodialyser, haemodiafilter or haemofilter have been specified to ensure 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. Connector
31、s with either fixed or loose locking shells are permitted. This International Standard reflects the consensus of physicians, 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
32、supersede any national regulation. DIN EN ISO 8638:2014-03 EN ISO 8638:2014 (E) 4 1 Scope This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as “the device”) and (integral and non-integral) transducer pro
33、tectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. This International Standard does not apply to: haemodialysers, haemodiafilters or haemofilters; plasmafilters; haemoperfusion devices; vascular access devices; blood pumps; pressure monitors for the extracor
34、poreal 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 haemoconcent
35、rators are specified in ISO 8637. 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) a
36、pplies. ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings ISO 7864, Sterile hypodermic needles for single use ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management
37、process ISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood DIN EN ISO 8638:2014-03 EN ISO 8638:2014 (E) 5 ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals ISO 10993-11, Biological evaluation
38、 of medical devices Part 11: Tests for systemic toxicity 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 air capture chamber component intended to capture air and which can provide compliance to the blood circuit or allow pressure to be monit
39、ored NOTE Air capture chambers are also known as drip chambers, bubble traps or venous and arterial blood chambers. 3.2 extracorporeal blood circuit blood tubing and integral accessory tubing, including fluid and infusion tubing, for attaching the extracorporeal blood circuit to pressure monitors an
40、d integral components EXAMPLES (Of integral components.) Air-capture chambers and transducer protectors. 3.3 fluid pathway internal surfaces of the extracorporeal blood circuit 3.4 labelling written, printed, graphic or electronic matter that: is affixed to a medical device or any of its containers
41、or wrappers or accompanies a medical device and which is related to identification, technical description and use of that medical device, but excluding shipping documents 3.5 pump segment portion of the extracorporeal blood circuit (3.2) that is acted upon by the blood pump 3.6 transducer protector
42、pressure-transmitting sterile barrier component of the extracorporeal blood circuit (3.2) that is intended to provide an interconnection between the extracorporeal blood circuit and the haemodialysis machine while allowing the pressure within the extracorporeal blood circuit to be measured by the ma
43、chine 4 Requirements 4.1 Biological safety Parts of the device that are intended to come into direct or indirect contact with blood shall be evaluated for freedom from biological hazards, in accordance with 5.2. DIN EN ISO 8638:2014-03 EN ISO 8638:2014 (E) 6 NOTE Attention is drawn to the need to es
44、tablish whether national regulations or national standards governing toxicology and biocompatibility testing exist in the country in which the device is produced and, if applicable, in the countries in which the device is to be marketed. 4.2 Sterility All fluid contacting surfaces of the device, and
45、 the mating surfaces of all connectors integral to the device, shall be sterile. Compliance shall be verified in accordance with 5.3. 4.3 Non-pyrogenicity The blood pathway of the device shall be non-pyrogenic. Compliance shall be verified in accordance with 5.4. 4.4 Mechanical characteristics 4.4.1
46、 Structural integrity The device shall be capable of withstanding a positive pressure of 1,5 the manufacturers recommended maximum pressure and a negative pressure not exceeding 700 mmHg (93,3 kPa below atmospheric pressure) or the highest obtainable negative pressure if at high elevation, when test
47、ed in accordance with 5.5.1. 4.4.2 Connectors to haemodialyser, haemodiafilter or haemofilter 4.4.2.1 Except where the haemodialyser, haemodiafilter or haemofilter and the extracorporeal blood circuit are designed as an integral system, the dimensions of the connectors for the haemodialyser, haemodi
48、afilter or haemofilter shall be as given in Figure 1. Compliance shall be verified in accordance with 5.5.2. 4.4.2.2 Connectors made of semi-rigid materials shall meet the performance requirements of ISO 594-2. 4.4.3 Connectors to vascular access device Except where the extracorporeal blood circuit and the vascular access device are an integral system, the dimensions of the connectors intended for connection to vasc
