BS EN ISO 3826-1-2013 Plastics collapsible containers for human blood and blood components Conventional containers《人类血液及血液成分用塑料可折叠容器 常规容器》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 3826-1:2013Plastics collapsible containersfor human blood and bloodcomponentsPart 1: Conventional containers (ISO3826-1:2013)BS EN ISO 3826-1:2013 BRITISH STANDARDNatio

2、nal forewordThis British Standard is the UK implementation of EN ISO3826-1:2013. It supersedes BS EN ISO 3826-1:2003 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on requ

3、est to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 72693 4ICS 11.040.20Compliance with a British St

4、andard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2013.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3826-1 June 2013 ICS

5、 11.040.20 Supersedes EN ISO 3826-1:2003English Version Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013) Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches conventionnelles (ISO 3826-1:2013) Kun

6、ststoffbeutel 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 stipulate the conditions for giving this European Stand

7、ard 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 Standard exists in three official versions (English

8、, 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 national standards bodies of Austria, Belgium, Bul

9、garia, 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, T

10、urkey 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 worldwide for CEN national Members. Ref. No. E

11、N ISO 3826-1:2013: EBS EN ISO 3826-1:2013EN ISO 3826-1:2013 (E) 3 Foreword This 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 “No

12、n-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 December 2013, and conflicting national standards shall be withdrawn at the lates

13、t 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 and/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 bee

14、n 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, see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC I

15、nternal 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, Iceland

16、, 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 3826-1:2013 has been approved by CEN as EN ISO 3826-1:2013 without any modificatio

17、n. BS EN ISO 3826-1:2013EN ISO 3826-1:2013 (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 Commission and the Eur

18、opean Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC, Medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at

19、 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 Correspondence b

20、etween this European Standard and Directive 93/42/EEC, Medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.2.3, 6.2.8, 6.3, 7.5 7.2 Only the protection to the patients is explicitly addressed. The part of ER 7.2 regarding

21、the packaging is not fully addressed. 5.1 to 5.8, 6.2.5 to 6.2.8, 6.3 7.3 Only the first half sentence of ER 7.3 is addressed. 5.6.3, 6.2.6, 6.2.7, 6.3, 6.4.3, 8.1 7.5 (first and second paragraph) The part of ER 7.5 relating to phthalates is not explicitly covered. 5.7, 5.8, 6.4.2 7.6 5.7, 5.8, 6.2.

22、2, 6.4.2 8.1 The part of ER 8.1 relating to easy handling is not addressed. 6.2.2, 7.4, 7.5 8.3 6.2.2 8.4 6.2.1 8.5 5.8, 5.9 9.1 Restrictions indicated on the label or in the instructions for use are not addressed. 5.7, 5.8.1 9.2 (first indent) 5.6, 5.9, 6.2.7 12.7.1 Only resistance to mechanical st

23、ress is addressed. 8.2 to 8.5 13.1 8.1 13.2 8.2 to 8.5 13.3 The part of ER 13.3 related to authorized representative is not addressed. 8.2 to 8.5 13.4 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 3826-1:20

24、13ISO 3826-1:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Dimensions and designation . 24.1 Dimensions . 24.2 Designation example 25 Design 25.1 General . 25.2 Air content 25.3 Emptying under pressure 25

25、.4 Pilot samples . 25.5 Rate of collection . 35.6 Collection and transfer tube(s) . 55.7 Blood-taking needle 55.8 Outlet port(s) 65.9 Suspension 66 Requirements 66.1 General . 66.2 Physical requirements 76.3 Chemical requirements 86.4 Biological requirements 97 Packaging 108 Labelling .108.1 General

26、 108.2 Label on plastics container 108.3 Label on over-package . 118.4 Label on shipping box 118.5 Label requirements 119 Anticoagulant and/or preservative solution .12Annex A (normative) Chemical tests .13Annex B (normative) Physical tests 18Annex C (normative) Biological tests 20Bibliography .23BS

27、 EN ISO 3826-1:2013ISO 3826-1:2013(E)ForewordISO (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 ISO technical committees. Each member body i

28、nterested 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 closely with the International Electrotechn

29、ical 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. Draft International Standards adopted by the

30、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 document may be the subject of patent rights. I

31、SO 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, infusion and injection, and blood processing equipment for medical and pharmaceutical use.This second edition cancels and replaces the first edition (

32、ISO 3826-1:2003), of which it constitutes a minor revision with the following changes: Figure 1 on the schematic representation of plastics containers has been updated; Table 1 has been amended to include a plastics container with a nominal capacity of 600 ml; subclause 5.6.5 on requirements for ste

33、rile connection transfer tubing has been added; 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; subclauses 5.8.3 and 5.8.4 on further requirements for the outlet port(s) have been added; Clause B.5 on a test for sterile connectio

34、n of tubing has been added; Annex C on biological tests has been completely revised and shortened in order to incorporate the linkage to the ISO 10993 series; the Bibliography has been updated; minor editorial changes have been made throughout the whole document.ISO 3826 consists of the following pa

35、rts, under the general title Plastics collapsible containers for human blood and blood components: Part 1: Conventional containers Part 2: Graphical symbols for use on labels and instruction leaflets Part 3: Blood bag systems with integrated featuresThe following parts are under preparation: Part 4:

36、 Aphaeresis blood bag systems with integrated featuresiv ISO 2013 All rights reservedBS EN ISO 3826-1:2013ISO 3826-1:2013(E)IntroductionIn some countries, national pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this part of ISO 3826.The

37、 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 components of the materials and their methods of manufacture, details of manufacture of the pla

38、stics 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 additives that have been used.Universal leucocyte depletion is mandatory in various count

39、ries. 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 blood components is maintained as high as necessary,b) make possible efficient and safe

40、collection, identification, storage, separation, and transfusion of the contents, with 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 representativ

41、e 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 with appropriate resistance to breakage and deterioration. ISO 2013 All rights reserved

42、 vBS EN ISO 3826-1:2013BS EN ISO 3826-1:2013Plastics collapsible containers for human blood and blood components Part 1: Conventional containers1 ScopeThis part of ISO 3826 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete w

43、ith collecting tube outlet port(s), 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

44、 application envisaged.This part of 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

45、of ISO 3826 is not applicable to plastics 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

46、references, the latest edition of the 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 evaluati

47、on of medical devices Part 1: Evaluation 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,

48、Biological evaluation of medical devices 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 an

49、d definitionsFor the purposes of this 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 applicableINTERNATIONAL STANDARD ISO 3826-1:2013(E) ISO 2013 All rights reserved 1BS EN ISO 3826-1:2013ISO 3826-1:2013(E)3.2shelf lifeperiod between the date of sterilization and the expiry date after which the plastics container(s) should not b