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1、BRITISH STANDARD BS EN ISO 3826-1:2003 Incorporating Corrigendum No. 1 Plastics collapsible containers for human blood and blood components Part 1: Conventional containers The European Standard EN ISO 3826-1:2003 has the status of a British Standard ICS 11.040.20 ? Licensed Copy: sheffieldun sheffie
2、ldun, na, Fri Nov 17 10:08:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 3826-1:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 12 December 2003 BSI 21 January 2004 ISBN 0 580 43057 X National foreword This British Standard is
3、the official English language version of EN ISO 3826-1:2003. It is identical with ISO 3826-1:2003. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs, which has the responsibility to: A list of organizations represented on this committee can be obtained on requ
4、est to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI E
5、lectronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers
6、to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document
7、comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 20, the Annex ZA page, the Annex ZB page, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates
8、when the document was last issued. Amendments issued since publication Amd. No. DateComments 14982 Corrigendum No. 1 21 January 2004 Corrected EN ISO foreword, incorporating the Annex ZA and Annex ZB pages Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:08 GMT+00:00 2006, Uncontrolled C
9、opy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3826-1 November 2003 ICS 11.040.20 English version Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826- 1:2003) Poches en plastique souple pour le sang et les composants
10、 du sang - Partie 1: Poches conventionnelles (ISO 3826- 1:2003) Kunststoffbeutel fr menschliches Blut und Blutbestandteile - Teil 1: Konventionelle Beutel (ISO 3826-1:2003) This European Standard was approved by CEN on 14 November 2003. CEN members are bound to comply with the CEN/CENELEC Internal R
11、egulations 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 Management Centre or to any CEN member. This
12、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 Management Centre has the same status as the official versions. CEN members are the na
13、tional standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE
14、 NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2003 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 3826-1:2003 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08
15、:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CORRECTED 2003-12-17 Foreword This document (EN ISO 3826-1:2003) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use“ in collaboration with Technical Committee CEN/TC 205 “
16、Non-active medical devices“, the secretariat of which is held by BSI. 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 May 2004, and conflicting national standards shall be withdrawn at the latest
17、by May 2004. 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 Directive(s). For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this doc
18、ument. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, N
19、etherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 3826-1:2003 has been approved by CEN as EN ISO 3826-1:2003 without any modifications. NOTE Normative references to International Standards are listed in Annex ZA (normative).
20、 EN ISO 38261:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 3826-1:2003(E) OSI 3002 INTERNATIONAL STANDARD ISO 3826-1 First edition 2003-11-15 Plastics collapsible containers for human blood and blood components P
21、art 1: Conventional containers Poches en plastique souple pour le sang et les composants du sang Partie 1: Poches conventionnelles EN ISO 38261:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-6283 O1:(3002E) DPlcsid Fremia ihTs PDF f
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25、nUeto sswrehise specified, on trap fo this lbupictaion maeb y cudorperro de tuilizi den yna form ro na ybm ynae,s lecetrinoc ro mceinahcla, incliduntohp gcoiypodna gn micrfoilm, wittuoh repmissii now nritign from ietI rehSa Ot tsserdda eh ebolw or ISOs memreb i ydobn the cnuotfo yr ttseuqer ehe.r IS
26、O cirypothg fofice saCe tsopale 65 eneG 1121-HC 02 av leT. 4 + 10 947 22 1 11 xaF0 947 22 14 + 9 74 E-mial coirypthgis.o gro We bwww.is.o gro ii ISO 3002 Allr ihgtsser edevr EN ISO 38261:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI I
27、S-6283 O1:(3002E) I SO 3002 All irhgts seredevr iii Contents Page Forewordiv Introduction v 1 Scope1 2 Normative references .1 3 Terms and definitions.1 4 Dimensions and designation.2 4.1 Dimensions2 4.2 Designation example2 5 Design 2 5.1 General.2 5.2 Air content .2 5.3 Emptying under pressure.2 5
28、.4 Pilot samples.2 5.5 Rate of collection 2 5.6 Collection and transfer tube(s)4 5.7 Blood-taking needle4 5.8 Outlet port(s) .4 5.9 Suspension5 6 Requirements 5 6.1 General.5 6.2 Physical requirements5 6.3 Chemical requirements 7 6.4 Biological requirements.8 7 Packaging 8 8 Labelling.9 8.1 General.
29、9 8.2 Label on plastics container9 8.3 Label on over-package.9 8.4 Label on shipping box10 8.5 Label requirements.10 9 Anticoagulant and/or preservative solution.10 Annex A (normative) Chemical tests11 Annex B (normative) Physical tests .16 Annex C (normative) Biological tests.17 Bibliography .20 EN
30、 ISO 38261:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-6283 O1:(3002E) iv I SO 3002 All irhgts seredevr Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
31、 member bodies). The work of preparing International Standards is normally carried out through ISO 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, gover
32、nmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates 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 D
33、irectives, Part 2. The main task of technical committees is to prepare International Standards. 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
34、bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 3826-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusio
35、n and injection equipment for medical and pharmaceutical use. This first edition of ISO 3826-1, together with other parts of ISO 3826 under preparation, cancels and replaces ISO 3826:1993. ISO 3826 consists of the following parts, under the general title Plastics collapsible containers for human blo
36、od and blood components: Part 1: Conventional containers The following part is under preparation: Part 2: Graphical symbols EN ISO 38261:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-6283 O1:(3002E) I SO 3002 All irhgts seredevr v
37、Introduction In some countries national pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this part of ISO 3826. The manufacturers of the plastics container, or the suppliers, are expected to disclose in confidence to the national control
38、authority, if requested by them, full details of the plastics material(s) and the components of the materials and their methods of manufacture, details of manufacture of the plastics containers, including the chemical names and quantities of any additives, whether incorporated by the manufacturer of
39、 the plastics containers or present in the raw material, as well as full details of any additives that have been used. Universal leucocyte depletion is mandatory in various countries. This part of ISO 3826 is considered a basic document for future standards which include technical innovations, e.g.
40、integrated leucocyte filters. The requirements in this part of ISO 3826 are intended to a) ensure that the quality of blood and blood components is maintained as high as necessary; b) make possible efficient and safe collection, identification, storage, separation and transfusion of the contents, wi
41、th special attention to reducing or minimizing the risks resulting from contamination, in particular microbiological contamination, air embolism, errors in identification of plastics containers and any representative samples of contents, interaction between the plastics container and its contents; c
42、) ensure functional compatibility when used in combination with transfusion sets as specified in ISO 1135-4; d) provide appropriate resistance to breakage and deterioration in a package of minimal mass and volume. EN ISO 38261:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:08 GMT+
43、00:00 2006, Uncontrolled Copy, (c) BSI blank EN ISO 38261:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADR IS-6283 O1:(3002E) I SO 3002 All irhgts seredevr 1 Plastics collapsible containers for human blood and bloo
44、d components Part 1: Conventional containers 1 Scope This part of ISO 3826 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle and with optional transfer tube(s), for the co
45、llection, storage, processing, transport, separation and administration of blood and blood components. The plastics containers may contain anticoagulant and/or preservative solutions, depending on the application envisaged. This part of ISO 3826 is also applicable to multiple units of plastics conta
46、iners, e.g. to double, triple, quadruple or multiple units. Unless otherwise specified, all tests specified in this part of ISO 3826 apply to the plastics container as prepared ready for use. This part of ISO 3826 is not applicable to plastics containers with an integrated filter. 2 Normative refere
47、nces 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) applies. ISO 1135-3:1986, Transfusion equipment for m
48、edical use Part 3: Blood-taking set ISO 1135-4:1998, Transfusion equipment for medical use Part 4: Transfusion sets for single use ISO 3696:1987, Water for analytical laboratory use Specification and test methods 3 Terms and definitions For the purposes of this document, the following terms and defi
49、nitions apply. 3.1 plastics container container, of plastics material, complete with collecting tube and needle, port(s), anticoagulant and/or preservative solutions and transfer tube(s) and associated container(s), where applicable 3.2 shelf-life period between the date of sterilization and the expiry date after which the plastics container(s) should not be used for the collection of blood EN ISO 38261:2003 Licensed Copy: sheffieldun she