1、September 2013 Translation by DIN-Sprachendienst.English price group 15No 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).
2、ICS 11.040.20!%(k“2059472www.din.deDDIN EN ISO 3826-1Plastics collapsible containers for human blood and bloodcomponents Part 1: Conventional containers (ISO 3826-1:2013);English version EN ISO 3826-1:2013,English translation of DIN EN ISO 3826-1:2013-09Kunststoffbeutel fr menschliches Blut und Blut
3、bestandteile Teil 1: Konventionelle Beutel (ISO 3826-1:2013);Englische Fassung EN ISO 3826-1:2013,Englische bersetzung von DIN EN ISO 3826-1:2013-09Poches en plastique souple pour le sang et les composants du sang Partie 1: Poches conventionnelles (ISO 3826-1:2013);Version anglaise EN ISO 3826-1:201
4、3,Traduction anglaise de DIN EN ISO 3826-1:2013-09SupersedesDIN EN ISO 3826-1:2004-04www.beuth.deDocument comprises 32 pagesIn case of doubt, the German-language original shall be considered authoritative.09.13 DIN EN ISO 3826-1:2013-09 2 A comma is used as the decimal marker. National foreword This
5、 document (EN ISO 3826-1:2013) 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 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German b
6、ody involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-02 AA Transfusions-/Infusionsbehltnisse und gerte aus Kunststoffen. The DIN Standards corresponding to the International Standards referred to in this document are as follows: I
7、SO 1135-4 DIN EN ISO 1135-4 ISO 3696 DIN ISO 3696 ISO 3826-2 DIN EN ISO 3826-2 ISO 3826-3 DIN EN ISO 3826-3 ISO 9626 DIN EN ISO 9626 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-4 DIN EN ISO 10993-4 ISO 10993-5 DIN EN ISO 10993-5 ISO 10993-10 DIN EN ISO 10993-10 ISO 10993-11 DIN EN ISO 10993-11 ISO 1099
8、3-12 DIN EN ISO 10993-12 ISO 15223-1 DIN EN ISO 15223-1 DIN EN ISO 3826 consists of the following parts, under the general title Plastics collapsible containers for humanblood and blood components: Part 1: Conventional containers Part 2: Graphical symbols for use on labels and instruction leaflets P
9、art 3: Blood bag systems with integrated features Part 4: Aphaeresis blood bag systems with integrated features (in preparation) Amendments This standard differs from DIN EN ISO 3826-1:2004-04 as follows: a) Figure 1 on the schematic representation of plastics containers has been updated; b) Table 1
10、 has been amended to include a plastics container with a nominal capacity of 600 ml; c) Subclause 5.6.5 on requirements for sterile connection transfer tubing has been added; d) Subclause 5.8.1 on the outlet port(s) has been amended by a specification for placement of the septum and by a Note 2; e)
11、Subclauses 5.8.3 and 5.8.4 on further requirements for the outlet port(s) have been added; DIN EN ISO 3826-1:2013-09 3 f) Subclause B.5 on a test for sterile connection of tubing has been added; g) Annex C on biological tests has been completely revised and shortened in order to incorporate the link
12、age to the ISO 10993 series; h) the Bibliography has been updated; i) Annex ZA has been completely revised and updated; j) minor editorial changes have been made throughout the whole document. Previous editions DIN 58361-4: 1980-09 DIN 58361-5: 1980-02 DIN 58361-6: 1983-03 DIN ISO 3826: 1996-09 DIN
13、EN ISO 3826-1: 2004-04 DIN EN ISO 3826-1:2013-09 4 National Annex NA (informative) Bibliography DIN EN ISO 1135-4, Infusion equipment for medical use Part 4: Transfusion sets for single use DIN EN ISO 3826-2, Plastics collapsible containers for human blood and blood components Part 2: Graphical symb
14、ols for use on labels and instruction leaflets DIN EN ISO 3826-3, Plastics collapsible containers for human blood and blood components Part 3: Blood bag systems with integrated features DIN EN ISO 9626, Stainless steel needle tubing for manufacture of medical devices DIN EN ISO 10993-1, Biological e
15、valuation 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 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cyto
16、toxicity DIN EN ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization DIN EN ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity DIN EN ISO 10993-12, Biological evaluation of medical devices Part 12: Sample
17、 preparation and reference materials DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN ISO 3696, Water for analytical laboratory use Specification and test methods EUROPEAN STANDARD NORME EUROP
18、ENNE EUROPISCHE NORM EN ISO 3826-1 June 2013 ICS 11.040.20 Supersedes EN ISO 3826-1:2003English Version Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO3826-1:2013) Poches en plastique souple pour le sang et les composants du sang - Partie 1
19、: Poches conventionnelles (ISO 3826-1:2013) Kunststoffbeutel fr menschliches Blut und Blutbestandteile - Teil 1: Konventionelle Beutel (ISO 3826-1:2013) This European Standard was approved by CEN on 22 May 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulat
20、e 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 European Stan
21、dard 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 are the nat
22、ional 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, Romania, Sl
23、ovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved
24、 worldwide for CEN national Members. Ref. No. EN ISO 3826-1:2013: EContents PageForeword 3Introduction 41 Scope . 52 Normative references 53 Terms and definitions . 54 Dimensions and designation . 64.1 Dimensions . 64.2 Designation example 65 Design 65.1 General . 65.2 Air content 65.3 Emptying unde
25、r pressure 65.4 Pilot samples . 65.5 Rate of collection . 75.6 Collection and transfer tube(s) . 95.7 Blood-taking needle 95.8 Outlet port(s) . 105.9 Suspension . 106 Requirements . 106.1 General 106.2 Physical requirements . 116.3 Chemical requirements. 126.4 Biological requirements . 137 Packaging
26、 148 Labelling .148.1 General 148.2 Label on plastics container 148.3 Label on over-package . 158.4 Label on shipping box 158.5 Label requirements 159 Anticoagulant and/or preservative solution .16Annex A (normative) Chemical tests .17Annex B (normative) Physical tests 22Annex C (normative) Biologic
27、al tests 24Bibliography .28Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices 27 DIN EN ISO 3826-1:2013-09 EN ISO 3826-1:2013 (E) 2Foreword This document (EN ISO 3826-1:2013) has been prepared by Technical Co
28、mmittee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use“ in collaboration with 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
29、her by publication of an identical text or by endorsement, at the latest by December 2013, and conflicting national standards shall be withdrawn at the latest by December 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN a
30、nd/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 3826-1:2003. 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
31、 of EU Directive(s). For relationship with EU Directive, 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, Be
32、lgium, 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, Swit
33、zerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 3826-1:2013 has been approved by CEN as EN ISO 3826-1:2013 without any modification. DIN EN ISO 3826-1:2013-09 EN ISO 3826-1:2013 (E) 3 IntroductionIn some countries, national pharmacopoeias or other government regulations ar
34、e 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 authority, if requested by them, full details of the plastics material(s) and the componen
35、ts 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 the plastics containers or present in the raw material, as well as full details of any ad
36、ditives that have been used.Universal leucocyte depletion is mandatory in various countries. This part of ISO 3826 is considered a basic document for other standards which include technical innovations.The requirements in this part of ISO 3826 are intended toa) ensure that the quality of blood and b
37、lood components is maintained as high as necessary,b) make possible efficient and safe collection, identification, storage, separation, and transfusion of the contents, with special attention to reducing or minimizing the risks resulting from contamination, in particular, microbiological contaminati
38、on, air embolism, errors in identification of plastics containers and any representative samples of contents, interaction between the plastics container and its contents,c) ensure functional compatibility when used in combination with transfusion sets as specified in ISO 1135-4,d) provide a package
39、with appropriate resistance to breakage and deterioration.DIN EN ISO 3826-1:2013-09 EN ISO 3826-1:2013 (E) 41 ScopeThis part of ISO 3826 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s),
40、integral needle, and with optional transfer tube(s), for the collection, 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
41、ISO 3826 is also applicable to multiple units of plastics containers, 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 pla
42、stics containers with an integrated filter.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of th
43、e referenced document (including any amendments) applies.ISO 1135-4:2012, Transfusion equipment for medical use Part 4: Transfusion sets for single useISO 3696:1987, Water for analytical laboratory use Specification and test methodsISO 10993-1, Biological evaluation of medical devices Part 1: Evalua
44、tion and testing within a risk management processISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interactions with bloodISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicityISO 10993-10, Biological evaluation of medical dev
45、ices Part 10: Tests for irritation and skin sensitizationISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicityISO 10993-12, Biological evaluation of medical devices Part 12: Sample preparation and reference materials3 Terms and definitionsFor the purposes of thi
46、s document, the following terms and definitions apply.3.1plastics containerbag, 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 applicableDIN EN ISO 3826-1:2013-09 EN ISO 38
47、26-1:2013 (E) 5 3.2shelf lifeperiod between the date of sterilization and the expiry date after which the plastics container(s) should not be used for the collection of blood4 Dimensions and designation4.1 DimensionsFigure 1 illustrates the components of a plastics container. The values of the dimen
48、sions shown in Figure 1 are binding and form part of the requirements of this part of ISO 3826; the dimensions given in Table 1 are for guidance only.4.2 Designation examplePlastics containers are designated using the descriptor words “Plastics container” followed by the number of this part of ISO 3
49、826, followed by the nominal capacity of the container, in millilitres. For example, the designation of a plastics container with a nominal capacity of 500 ml in accordance with this part of ISO 3826 isPlastics container ISO 3826-1:2013, 5005 Design5.1 GeneralThe design and manufacture of the plastics container shall provide for the safe and convenient
