DIN EN ISO 22413-2013 Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413 2010) German version EN ISO 22413 2013《药物制剂输送装置 试验方法和要求(ISO 22413-201.pdf

1、October 2013Translation by DIN-Sprachendienst.English price group 12No 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).ICS

2、 11.120.99!%)jF“2067135www.din.deDDIN EN ISO 22413Transfer sets for pharmaceutical preparations Requirements and test methods (ISO 22413:2010);English version EN ISO 22413:2013,English translation of DIN EN ISO 22413:2013-10berleitgerte fr pharmazeutische Zubereitungen Anforderungen und Prfverfahren

3、 (ISO 22413:2010);Englische Fassung EN ISO 22413:2013,Englische bersetzung von DIN EN ISO 22413:2013-10Ensemble de transfert pour prparations pharmaceutiques Exigences et mthodes dessai (ISO 22413:2010);Version anglaise EN ISO 22413:2013,Traduction anglaise de DIN EN ISO 22413:2013-10SupersedesDIN E

4、N ISO 22413:2011-08www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 23 pages10.13 DIN EN ISO 22413:2013-10 2 A comma is used as the decimal marker. National foreword This document (EN ISO 22413:2013) has been prepared by Technical Commit

5、tee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” (Secretariat: DIN, Germany) in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in it

6、s 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: ISO 594-1 DIN EN 2

7、0594-1 ISO 594-2 DIN EN 1707 ISO 7864:1993 DIN EN ISO 7864:1996-01 ISO 7886-1 DIN EN ISO 7886-1 ISO 8362 (all parts) DIN (EN) ISO 8362 (all parts) ISO 8536 (all parts) DIN (EN) ISO 8536 (all parts) ISO 8871 (all parts) DIN (EN) ISO 8871 (all parts) ISO 15223-1 DIN EN ISO 15223-1 ISO 15747 DIN EN ISO

8、 15747 ISO 15759 DIN ISO 15759 Amendments This standard differs from DIN EN ISO 22413:2011-08 as follows: a) Annex ZA has been revised. Previous editions DIN 58373: 2004-11 DIN EN ISO 22413: 2011-08 DIN EN ISO 22413:2013-10 3 National Annex NA (informative) Bibliography DIN EN 1707, Conical fittings

9、 with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Lock fittings DIN EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements DIN EN ISO 7864:1996-01, Sterile hypodermic needles for sin

10、gle use DIN EN ISO 7886-1, Sterile hypodermic syringes for single use Part 1: Syringes for manual use DIN (EN) ISO 8362 (all parts), Injection containers and accessories DIN (EN) ISO 8536 (all parts), Infusion equipment for medical use DIN (EN) ISO 8871 (all parts), Elastomeric parts for parenterals

11、 and for devices for pharmaceutical use 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 EN ISO 15747, Plastic containers for intravenous injections DIN ISO 15759, Medical infusion equipment P

12、lastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process DIN EN ISO 22413:2013-10 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22413 February 2013 ICS 11.040.20 Supersedes EN ISO 22413:2011English Vers

13、ion Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010) Ensemble de transfert pour prparations pharmaceutiques - Exigences et mthodes dessai (ISO 22413:2010) berleitgerte fr pharmazeutische Zubereitungen - Anforderungen und Prfverfahren (ISO 22413:2010) Thi

14、s European Standard was approved by CEN on 8 January 2013. CEN members are bound to comply 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 referen

15、ces 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, French, German). A version in any other language made by translation under the responsibility of a CEN m

16、ember 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, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

17、France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHE

18、S 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. EN ISO 22413:2013: E2DIN EN ISO 22413:2013-10EN ISO 22413:2013 (E) Contents Page Foreword . 3 Introduction

19、. 4 1 Scope . 5 2 Normative references. 5 3 Design and designation . 5 3.1 Design . 5 3.2 Design for a transfer set with housing. 8 3.3 Designation . 8 4 Material 8 5 Physical requirements . 9 5.1 Particulate contamination . 9 5.2 Tensile strength 9 5.3 Tightness 9 5.4 Free flow 9 5.5 Piercing devic

20、e . 9 5.6 Penetration force 9 5.7 Fragmentation 10 5.8 Air inlet and air outlet 10 5.9 Protective caps . 10 5.10 Transfer sets with a housing 10 5.11 Luer connector . 10 5.12 Filter for particles . 10 6 Chemical requirements . 10 7 Biological requirements 10 8 Testing of physical requirements . 10 8

21、.1 Particulate contamination . 10 8.2 Tensile strength 11 8.3 Tightness of transfer set . 11 8.4 Free flow 11 8.5 Piercing device . 11 8.6 Penetration force 11 8.7 Testing on fragmentation 11 8.8 Effectiveness of air inlet and air outlet with air filter 11 8.9 Efficiency of protective caps 11 8.10 L

22、uer connector . 11 8.11 Filter for particles 11 9 Testing of chemical requirements 12 10 Testing of biological requirements 12 11 Packaging . 12 12 Storage 12 13 Labelling 12 13.1 Unit container . 12 13.2 Shelf or multi-unit container . 12 Annex A (normative) Testing of fragmentation of transfer set

23、s with plastic piercing devices 13 Annex B (normative) Testing of fragmentation of transfer sets with metal piercing devices . 15 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 17 Bibliography 19 The text

24、 of ISO 22413:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 22413:2013 by Technical Committ

25、ee 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, either by publication of an identical text or by endorsement, at the latest by August 2013, and conflicting national standards shall be withdra

26、wn at the latest by August 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 22413:2011. This docu

27、ment 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. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN-

28、CENELEC Internal 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

29、, Iceland, 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 22413:2010 has been approved by CEN as EN ISO 22413:2013 without any modi

30、fication. Foreword3DIN EN ISO 22413:2013-10EN ISO 22413:2013 (E)Introduction Transfer sets for pharmaceutical preparations transmit fluids from one container to another. The transfer sets mix fluids or dissolve dry substances and are used in combination with infusion and injection containers. The tr

31、ansfer sets consist either of two piercing devices or of a piercing device in combination with a Luer connector, which may be connected with each other in different ways. Transfer sets may have a housing. Examples of different designs: a) two piercing devices connected to each other (similar to pier

32、cing devices of infusion containers); b) a metal cannula, bevelled on both sides or a combination of a) and b); c) metal cannulae mostly having a hub or a grip plate in the middle to be fixed to the plastic part; d) plastic piercing devices directly connected to a grip plate, or held by a tube at a

33、distance to allow a higher hydrostatic pressure; e) piercing devices with an additional ventilation channel that may end in the other tip or outside; f) piercing devices also with an air filter; g) piercing devices with housings serving, among other things, as a guide and a fixation on the connected

34、 containers for a secure, injury-free and contactless application; h) piercing device in combination with a Luer connector; i) piercing device in combination with a Luer connector and a particle filter. 4DIN EN ISO 22413:2013-10EN ISO 22413:2013 (E) 1 Scope This International Standard applies to ste

35、rilized single use transfer sets that are used for pharmaceutical preparations. 2 Normative references 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 re

36、ferenced document (including any amendments) applies. ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment

37、 Part 2: Lock fittings ISO 7864:1993, Sterile hypodermic needles for single use ISO 8362 (all parts), Injection containers and accessories ISO 8536 (all parts), Infusion equipment for medical use ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to

38、 be supplied Part 1: General requirements ISO 15747, Plastic containers for intravenous injections ISO 15759, Medical infusion equipment Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process 3 Design and designation 3.1 Design The designs of th

39、e individual components are given in Figures 1 to 7. The drawings serve as an illustration of possible transfer sets. Other designs are acceptable. The Key for Figures 1 to 7 is to be found on page 3. 5DIN EN ISO 22413:2013-10EN ISO 22413:2013 (E)Figure 1 Transfer set with one channel Figure 2 Trans

40、fer set with one channel in combination with a Luer connector Figure 3 Transfer set with an air inlet/air outlet Figure 4 Alternative transfer set with an air inlet/air outlet 6DIN EN ISO 22413:2013-10EN ISO 22413:2013 (E) Figure 5 Transfer set with an air inlet/air outlet in combination with a Luer

41、 connector Figure 6 Transfer set with two channels Figure 7 Alternative transfer set with two channels Key for Figures 1 to 7 1 piercing device 2 channel 3 channel with air filter for ventilation, optionally lockable 4 protective cap 7DIN EN ISO 22413:2013-10EN ISO 22413:2013 (E)5 connection of pier

42、cing devices by hub, grip plate or tube 6 female Luer connector 3.2 Design for a transfer set with housing The design of a transfer set with housing is given in Figure 8. The drawing serves as an illustration of a possible transfer set. Other designs are acceptable. Key 1 piercing device 2 channel 3

43、 housing Figure 8 Transfer set with housing 3.3 Designation Example 1: A transfer set without housing (NH) is designated by the term “Transfer set”, the number of this International Standard and the initials NH as follows: Transfer set ISO 22413 NH Example 2: A transfer set with housing (WH) is desi

44、gnated by the term “Transfer set”, the number of this International Standard and the initials WH as follows: Transfer set ISO 22413 WH 4 Material The materials for the transfer sets and their individual components shall comply with the requirements in accordance with Clause 5. If the components come

45、 into contact with the liquid to be transferred, the chemical and biological requirements in accordance with ISO 8536-4 shall be met. 8DIN EN ISO 22413:2013-10EN ISO 22413:2013 (E) Piercing devices are manufactured from appropriate materials, e.g. metal and/or plastic. 5 Physical requirements 5.1 Pa

46、rticulate contamination Transfer sets shall be manufactured under such conditions that minimize particulate contamination. All parts shall be smooth and clean. When tested in accordance with 8.1 the evaluation number of the particulate contamination shall not exceed 90. 5.2 Tensile strength 5.2.1 Wh

47、en tested as specified in 8.2 the transfer set shall withstand a static tensile force of not less than 15 N for 15 s. 5.2.2 When using metal piercing devices the steadiness under tensile or compressible force without breaking shall comply with the values listed in Table 2 of ISO 7864:1993. 5.3 Tight

48、ness The transfer set shall be air-tight, no leaks of air or liquid shall occur when tested in accordance with 8.3. Sterility shall be maintained. 5.4 Free flow When tested in accordance with 8.4 a free flow of air and/or liquid shall be ensured. 5.5 Piercing device The piercing devices shall be sui

49、table for penetration of the intended closure system for injection and/or infusion containers made of glass or plastic. After puncture, a free flow shall be ensured. When tested in accordance with 8.5 the surface of the piercing devices shall be smooth and free of burrs. The maximum diameter of the piercing device shall be u 6,5 mm. 5.6 Penetration force When tested in accordance with 8.6 the penetration forces determined in Table 1 shal