1、BRITISH STANDARDBS EN ISO 3826-3:2007Plastics collapsible containers for human blood and blood components Part 3: Blood bag systems with integrated featuresICS 11.040.20g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40
2、g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 3826-3:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2006 BSI 2008ISBN 978 0 580 52970 2National forewordThis British Standard is the UK implemen
3、tation of EN ISO 3826-3:2007. It is identical with ISO 3826-3:2006. It supersedes BS ISO 3826-3:2006 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request to its se
4、cretary.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 cannot confer immunity from legal obligations. Amendments issued since publicationAmd. No. Date Comments17100 Corrigen
5、dum No. 130 March 2007 Addition of supersession information30 April 2008 This corrigendum renumbers BS ISO 3826-3:2006 as BS EN ISO 3826-3:2007EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 3826-3December 2007ICS 11.040.20English VersionPlastics collapsible containers for human blood and bloo
6、dcomponents - Part 3: Blood bag systems with integratedfeatures (ISO 3826-3:2006)Poches en plastique souple pour le sang et les composantsdu sang - Partie 3: Systmes de poches pour le sang avecaccessoires intgrs (ISO 3826-3:2006)Kunststoffbeutel fr menschliches Blut und Blutbestandteile- Teil 3: Blu
7、tbeutelsysteme mit integrierten Merkmalen (ISO3826-3:2006)This European Standard was approved by CEN on 19 November 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without
8、 any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN 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
9、 by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, G
10、ermany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGM
11、anagement Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 3826-3:2007: EForeword The text of ISO 3826-3:2006 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusi
12、on and injection equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 3826-3:2007 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This European Standard shal
13、l be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2008, and conflicting national standards shall be withdrawn at the latest by June 2008. This document has been prepared under a mandate given to CEN by the European Commi
14、ssion and the European Free Trade Association, and supports essential requirements of EC Directive(s). For relationship with EC 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
15、of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Sl
16、ovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 3826-3:2006 has been approved by CEN as a EN ISO 3826-3:2007 without any modification. BS EN ISO 3826-3:2007Reference numberISO 3826-3:2006(E)INTERNATIONAL STANDARD ISO3826-3First edition2006-09-1
17、5Plastics collapsible containers for human blood and blood components Part 3: Blood bag systems with integrated features Poches en plastique souple pour le sang et les composants du sang Partie 3: Systmes de poches pour le sang avec accessoires intgrs BS EN ISO 3826-3:2007ii iiiForeword ISO (the Int
18、ernational 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 interested in a subject for which a technical committee ha
19、s 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 Electrotechnical Commission (IEC) on all matters of electrotechnical
20、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 technical committees are circulated to the member bodie
21、s 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. ISO shall not be held responsible for identifying any o
22、r all such patent rights. ISO 3826-3 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. ISO 3826 consists of the following parts, under the general title Plastics collapsible containers for human blood and blood components
23、: Part 1: Conventional containers Part 3: Blood bag systems with integrated features Part 2, which will cover the use of graphical symbols, is currently in preparation. BS EN ISO 3826-3:2007Introduction In some countries national pharmacopoeias, or other government regulations, are legally binding a
24、nd these requirements take precedence over this part of ISO 3826. The manufacturers or suppliers of the plastic containers are expected to disclose in confidence to the national control authority, if requested by them, full details of the plastic material(s) and the components of the materials and t
25、heir methods of manufacture, details of the manufacture of the plastic containers including the chemical names and quantities of any additives, whether incorporated by the manufacturer of the plastic containers or present in the raw material, as well as full details of any additives that have been u
26、sed. iv BS EN ISO 3826-3:20071Plastics collapsible containers for human blood and blood components Part 3: Blood bag systems with integrated features 1 Scope This part of ISO 3826 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented,
27、 sterile containers (blood bag systems). Blood bag systems need not contain all of the integrated features identified in this document. The integrated features refer to: leucocyte filter; pre-donation sampling device; top-and-bottom bag; platelet storage bag; needle stick protection device. In addit
28、ion to ISO 3826-1, which specifies the requirements of conventional containers, this part of ISO 3826 specifies additional requirements for blood bag systems using multiple units. This part of ISO 3826 does not cover automated blood collection systems. Unless otherwise specified, all tests specified
29、 in this part of ISO 3826 apply to the plastic container as prepared ready for use. Use chemical, physical and biological tests in accordance with ISO 3826-1, where applicable. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated
30、 references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 3826-1:2003, Plastics collapsible containers for human blood and blood components Part 1: Conventional containers BS EN ISO 3826-3:20072 3 Terms
31、and definitions For the purposes of this document, the terms and definitions given in ISO 3826-1 and the following apply. 3.1 leucocyte filter LCF filter used to reduce the content of leucocytes in blood or blood components 3.2 pre-donation sampling device PDS device integrated in the donor line of
32、blood bag systems and designed to separate the first volume of donated blood NOTE The pre-donation sampling device is integrated in the donor line through a Y-piece, such that blood may only flow into the pre-donation sampling device or into the blood bag. 3.3 top-and-bottom bag TBB bag containing t
33、op-and-bottom inlets and outlets NOTE The top-and-bottom bag is part of a multiple bag system and is designed to allow centrifugation of anticoagulated whole blood. After centrifugation the plasma is separated through the top and red cell concentrate through the bottom outlet of the bag. 3.4 platele
34、t storage bag PSB bag suitable for appropriate storage of a therapeutic dose of platelet concentrates, obtained from a single donation or a pool of donations NOTE The platelet storage bag can stand alone or be part of a blood bag system. 3.5 needle stick protection device NPD device integrated in th
35、e donor line of blood bag systems, containing the donor needle, and designed to prevent undesirable needle sticks after use of the donor needle 4 Dimensions and designation 4.1 Dimensions Figures 1 and 2 illustrate the components of a blood bag system with integrated features. The general drawings a
36、nd the drawing of each feature are for guidance only. The dimensions shall be in accordance with those listed in ISO 3826-1:2003, 4.1, Figure 1. 4.2 Designation example Plastics containers are designated using the descriptor words “Plastics container” followed by the number of this part of ISO 3826,
37、 in turn followed by the abbreviation of the relevant integrated feature given in Clause 3. For example, the designation of a plastics container with a leucocyte filter in accordance with this part of ISO 3826 is: Plastics container ISO 3826-3 LCF BS EN ISO 3826-3:20073Key 1 pre-donation sampling de
38、vice (PDS) 9 bottom outlet 2 pre-donation sampling bag 10 collection tube 3 multiple sampling device 11 transfer bags 4 blood-taking needle 12 empty transfer bag 5 needle stick protection device (NPD) 13 platelet storage bag (PSB) 6 blood bag system 14 bottom empty transfer bag 7 top-and-bottom bag
39、(TBB) 15 transfer bag with additive solution 8 (top) outlet 16 leucocyte filter (LCF) aMeans of closure. The means may be positioned at other sites. bIn the present configuration the TBB is the collection container and contains the anticoagulant. cIn the present configuration the LCF is a red cell c
40、oncentrate filter. Figure 1 Schematic representation of components of a blood bag system with integrated features Top-and-bottom bag system with integrated red cell filter, platelet storage bag and pre-donation sampling device BS EN ISO 3826-3:20074 Key 1 pre-donation sampling device (PDS) 8 outlet
41、2 pre-donation sampling bag 9 collection tube 3 multiple sampling device 10 transfer bags 4 blood-taking needle 11 empty transfer bag 5 needle stick protection device (NPD) 12 transfer bag with additive solution 6 blood bag system 13 leucocyte filter (LCF) 7 collection bag aMeans of closure. The mea
42、ns may be positioned at other sites. bIn the present configuration the collection bag contains the anticoagulant. cIn the present configuration the LCF is a whole blood filter. Figure 2 Schematic representation of components of a blood bag system with integrated features Quadruple blood bag system w
43、ith integrated whole blood filter and pre-donation sampling device 5 Design 5.1 Leucocyte filter 5.1.1 The leucocyte filter is integrated in plastic container(s) as a whole blood filter or a blood component filter. It is designed to reduce the leucocyte content of one whole blood unit or blood compo
44、nent unit. The filters may be designed to work by gravity or pressure filtration at 4 C or ambient temperature, depending on required specifications. Leucocyte filters may also be integrated in other transfusion equipment. Leucocyte filters might be subject to national requirements and standards. BS
45、 EN ISO 3826-3:200755.1.2 Manufacturers shall give recommendations for the intended use of the leucocyte filters considering parameters including: delay between blood collection and leucoreduction; capacity of the filter; blood filtration temperature; filtration height; use of pressure; suitability
46、for centrifugation. 5.2 Pre-donation sampling device 5.2.1 The pre-donation sampling device shall permit the collection, under aseptic conditions, of a range of donor samples taken into evacuated sample tubes. 5.2.2 If the pre-donation sampling device includes a collection pouch, then its capacity s
47、hall be at least 35 ml. 5.2.3 The pre-donation sampling device shall be designed to be filled with a mean flow rate of at least 50 ml/min when tested in accordance with ISO 3826-1:2003, Clause B.2. 5.2.4 Means shall be provided which prevent the return of blood and/or air from the sampling site towa
48、rds the donor and donation after the filling of the pre-donation sampling device. The means may or may not be integrated. For collection of specific samples, it may be necessary to avoid the presence of anticoagulant and haemolysis in the pre-donation sample. 5.2.5 Manufacturers shall give recommend
49、ations for the optimal use of the pre-donation sampling device. 5.3 Top-and-bottom bag 5.3.1 The top-and-bottom bag usually works with an automatic press system that allows the use of, for example, optical sensors and a residual volume between the top and bottom layer containing a large content of platelets and leucocytes (the buffy coat). 5.3.2 If tubes of top and bottom outlets have different dimensions, on request they shall be provided by the manufacturers. 5.4 Platelet storage bag 5.4.1 Platelet storage bags shall have good gas
