1、March 2008DEUTSCHE NORM English price group 10No part of this standard 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 11.040.20!$MP“1424591www
2、.din.deDDIN EN ISO 3826-3Plastics collapsible containers for human blood and bloodcomponents Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)English version of DIN EN ISO 3826-3:2008-03Kunststoffbeutel fr menschliches Blut und Blutbestandteile Teil 3: Blutbeutelsysteme mit integr
3、ierten Merkmalen (ISO 3826-3:2006)Englische Fassung DIN EN ISO 3826-3:2008-03www.beuth.deDocument comprises 16 pagesDIN EN ISO 3826-3:2008-03 2 National foreword This standard has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceut
4、ical use” in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Committee NA 063-02-02 AA Transfusions-/Infusionsb
5、ehltnisse und -gerte aus Kunststoffen. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. The DIN Standard corresponding to the International Standard r
6、eferred to in this document is as follows: ISO 3826-1:2003 DIN EN ISO 3826-1:2004-04 National Annex NA (informative) Bibliography DIN EN ISO 3826-1:2004-04, Plastics collapsible containers for human blood and blood components Part 1: Conventional containers (ISO 3826-1:2003) EUROPEAN STANDARD NORME
7、EUROPENNE EUROPISCHE NORM EN ISO 3826-3 December 2007 ICS 11.040.20 English Version Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006) Poches en plastique souple pour le sang et les composants du sang - Partie 3
8、: Systmes de poches pour le sang avec accessoires intgrs (ISO 3826-3:2006) Kunststoffbeutel fr menschliches Blut und Blutbestandteile -Teil 3: Blutbeutelsysteme mit integrierten Merkmalen (ISO 3826-3:2006) This European Standard was approved by CEN on 19 November 2007. CEN members are bound to compl
9、y with the CEN/CENELEC Internal Regulations 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 CEN Manageme
10、nt Centre or to any CEN member. This 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 CEN Management Centre has the same status as the
11、official versions. CEN members are the national standards bodies of 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, Slovakia,
12、 Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reserved worldwide fo
13、r CEN national Members. Ref. No. EN ISO 3826-3:2007: EContents Page Foreword3 Introduction.4 1 Scope 5 2 Normative references 5 3 Terms and definitions .6 4 Dimensions and designation6 5 Design .8 6 Requirements 10 7 Packaging 11 8 Labelling 12 9 Anticoagulant and/or preservative solution 13 Annex Z
14、A (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical Device 14 2 DIN EN ISO 3826-3:2008-03 EN ISO 3826-3:2007 (E) Foreword The text of ISO 3826-3:2006 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and
15、 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 shall be g
16、iven 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 Commission
17、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 of the
18、 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, Slovakia
19、, 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. 3 DIN EN ISO 3826-3:2008-03 EN ISO 3826-3:2007 (E) Introduction In some countries national pharmacopoeias, or other
20、 government regulations, are legally binding and 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 materia
21、l(s) and the components of the materials and their 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
22、full details of any additives that have been used. 4 DIN EN ISO 3826-3:2008-03 EN ISO 3826-3:2007 (E) 1 Scope This part of ISO 3826 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). Blood b
23、ag 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 addition to ISO 3826-1, which specifies the requireme
24、nts 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 in this part of ISO 3826 apply to the plastic c
25、ontainer 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 references, only the edition cited applies. For
26、 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 5 EN ISO 3826-3:2007 (E) DIN EN ISO 3826-3:2008-03 3 Terms and definitions For
27、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 blood bag systems an
28、d 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 top-and-bottom inlets
29、 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 platelet storage bag PSB ba
30、g 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 the donor line of bloo
31、d 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 and the drawing of ea
32、ch 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, in turn followed by
33、 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 6 DIN EN ISO 3826-3:2008-03 EN ISO 3826-3:2007 (E) Key 1 pre-donation sa
34、mpling device (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-bo
35、ttom bag (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 r
36、ed cell concentrate 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 7 EN ISO 3826-3:2007 (E) DIN EN ISO 3826-3:2008-03 Key 1 pre-don
37、ation sampling device (PDS) 8 outlet 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 coll
38、ection bag aMeans of closure. The means 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
39、features Quadruple blood bag system with 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 o
40、f one whole blood unit or blood component 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 na
41、tional requirements and standards. 8 DIN EN ISO 3826-3:2008-03 EN ISO 3826-3:2007 (E) 5.1.2 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 filtra
42、tion temperature; filtration height; use of pressure; suitability 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-donatio
43、n sampling device includes a collection pouch, then its capacity shall 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
44、prevent the return of blood and/or air from the sampling site towards 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
45、 the pre-donation sample. 5.2.5 Manufacturers shall give recommendations 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 volum
46、e 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
47、 gas permeability for both oxygen and carbon dioxide and shall allow storage of platelet concentrates under temperature controlled conditions for several days (under continuous agitation). 5.4.2 Platelet storability is also influenced by number of platelets, volume of platelet concentrate, size of t
48、he container and agitation and is usually assessed by observation of swirling and by measurement of pH, hypotonic shock response and aggregation. 9 EN ISO 3826-3:2007 (E) DIN EN ISO 3826-3:2008-03 5.5 Needle stick protection device Manufacturers shall give recommendations for the optimal use of the
49、needle stick protection device. Needle stick protection devices might be subject to national requirements and standards. 5.6 Air content The air contained in a filter sub-assembly or pre-donation pouch need not be included in the air volume calculation, in accordance with ISO 3826-1:2003, 5.2, if by design or operation of the system such inherent air does not end up in the final collected blood component product. The air volume limit requirement does apply to other containers, such as the top-and-bottom bag and the platelet bag, when t
