EN ISO 22413-2013 en Transfer sets for pharmaceutical preparations - Requirements and test methods《药物制剂转移装置 要求和试验方法》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 22413:2013Transfer sets forpharmaceutical preparations Requirements and testmethods (ISO 22413:2010)BS EN ISO 22413:2013 BRITISH STANDARDNational forewordThis British S

2、tandard is the UK implementation of EN ISO22413:2013. It is identical to ISO 22413:2010. It supersedes BS EN ISO22413:2011 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained

3、on request 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 82258 2ICS 11.040.20Compliance with a Bri

4、tish Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 April 2013.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22413 Februa

5、ry 2013 ICS 11.040.20 Supersedes EN ISO 22413:2011English Version 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 Zuber

6、eitungen - Anforderungen und Prfverfahren (ISO 22413:2010) This 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 withou

7、t 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, French, German). A version in any other la

8、nguage 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, Bulgaria, Croatia, Cyprus, Czech Republic, Denm

9、ark, 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, Turkey and United Kingdom. EUROPEAN COMMITTEE

10、 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. EN ISO 22413:2013: EBS EN ISO 22413:2013EN IS

11、O 22413:2013 (E) 3 Foreword The text 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

12、 ISO 22413:2013 by 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, either by publication of an identical text or by endorsement, at the latest by August 2013, and conflicting

13、 national standards shall be withdrawn 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 sup

14、ersedes EN ISO 22413:2011. 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 of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of

15、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, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedon

16、ia, France, Germany, Greece, Hungary, 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 a

17、s EN ISO 22413:2013 without any modification. BS EN ISO 22413:2013EN ISO 22413:2013 (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 C

18、EN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on Medical Devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been imp

19、lemented as a national standard in at 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 reg

20、ulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 5.1, 5.12, 6 7.2 6, 7 7.3 Presumption of conformity with the Essential Requirem

21、ents relating to biological evaluation can only be provided if the manufacturer chooses to apply the EN ISO 10993 series of standards, as proposed in the normative reference EN ISO 8536-4. 7 7.5 Presumption of conformity with the Essential Requirements relating to biological evaluation can only be p

22、rovided if the manufacturer chooses to apply the EN ISO 10993 series of standards, as proposed in the normative referenceEN ISO 8536-4. 5.3, 5.5, 5.7 7.6 5.8, 7 8.1 Presumption of conformity with the Essential Requirements relating to biological evaluation can only be provided if the manufacturer ch

23、ooses to apply the EN ISO 10993 series of standards, as proposed in the normative reference EN ISO 8536-4. BS EN ISO 22413:2013EN ISO 22413:2013 (E) 5 Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 5.9, 11, 12 8.3 7 8.4 Presumption of c

24、onformity with the Essential Requirements relating to biological evaluation can only be provided if the manufacturer chooses to apply the EN ISO 10993 series of standards, as proposed in the normative reference EN ISO 8536-4. 5.2, 5.6, 5.11 9.1 5.10.2 9.2 5.2, 5.6 12.7.1 5.4 12.8.1 13 13.3 The part

25、of 13.3 a) relating to the authorized representatives is not addressed. ERs 13.3 c) relating to the symbol STERILE and 13.3 f) relating to single-use are not fully addressed. 3.3 13.3 (b) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope

26、of this standard. BS EN ISO 22413:2013ISO 22413:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword .v Introductionvi 1 Scope1 2 Normative references1 3 Design and designation1 3.1 Design.1 3.2 Design for a transfer set with housing4 3.3 Designation 4 4 Material .4 5 Physical requirements

27、 5 5.1 Particulate contamination.5 5.2 Tensile strength.5 5.3 Tightness5 5.4 Free flow.5 5.5 Piercing device 5 5.6 Penetration force .5 5.7 Fragmentation6 5.8 Air inlet and air outlet6 5.9 Protective caps 6 5.10 Transfer sets with a housing6 5.11 Luer connector 6 5.12 Filter for particles 6 6 Chemic

28、al requirements.6 7 Biological requirements6 8 Testing of physical requirements 6 8.1 Particulate contamination.6 8.2 Tensile strength.7 8.3 Tightness of transfer set.7 8.4 Free flow.7 8.5 Piercing device 7 8.6 Penetration force .7 8.7 Testing on fragmentation .7 8.8 Effectiveness of air inlet and a

29、ir outlet with air filter.7 8.9 Efficiency of protective caps7 8.10 Luer connector 7 8.11 Filter for particles 7 9 Testing of chemical requirements .8 10 Testing of biological requirements8 11 Packaging.8 12 Storage .8 13 Labelling.8 13.1 Unit container 8 13.2 Shelf or multi-unit container 8 Annex A

30、 (normative) Testing of fragmentation of transfer sets with plastic piercing devices 9 BS EN ISO 22413:2013ISO 22413:2010(E) iv ISO 2010 All rights reservedAnnex B (normative) Testing of fragmentation of transfer sets with metal piercing devices 11 Bibliography 13 BS EN ISO 22413:2013ISO 22413:2010(

31、E) ISO 2010 All rights reserved vForeword ISO (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 inte

32、rested 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 Electrotechnica

33、l 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 t

34、echnical 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

35、SO shall not be held responsible for identifying any or all such patent rights. ISO 22413 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 22413:2007), of w

36、hich the scope was enhanced by introducing further product groups like transfer sets with integrated Luer connectors and particle filters. In that framework the following major changes were introduced: the Introduction was amended by h) and j); the Normative references were updated; the Figures in 3

37、.1 were updated; 5.11 and 8.10 on the physical requirements and testing for Luer connector were added; 5.12 and 8.11 on the physical requirements and testing for filter for particles were added. BS EN ISO 22413:2013ISO 22413:2010(E) vi ISO 2010 All rights reservedIntroduction Transfer sets for pharm

38、aceutical 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 transfer sets consist either of two piercing devices or of a piercing device in combination with a Lue

39、r 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 piercing devices of infusion containers); b) a metal cannula, bevelled on both sides or a combination of

40、 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 distance to allow a higher hydrostatic pressure; e) piercing devices with an additional ventilation

41、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 containers for a secure, injury-free and contactless application; h) piercing device in combination

42、 with a Luer connector; i) piercing device in combination with a Luer connector and a particle filter. BS EN ISO 22413:2013INTERNATIONAL STANDARD ISO 22413:2010(E) ISO 2010 All rights reserved 1Transfer sets for pharmaceutical preparations Requirements and test methods 1 Scope This International Sta

43、ndard applies to sterilized 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 late

44、st edition of the referenced 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 oth

45、er medical equipment 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, labellin

46、g and information to 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 Desi

47、gn The designs of the 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. BS EN ISO 22413:2013ISO 22413:2010(E) 2 ISO 2010 All rights reservedFigure 1 Tr

48、ansfer set with one channel Figure 2 Transfer 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 BS EN ISO 22413:2013ISO 22413:2010(E) ISO 2010 All rights reserved 3Figure 5 Trans

49、fer set with an air inlet/air outlet in combination with a Luer 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 BS EN ISO 22413:2013ISO 22413:2010(E) 4 ISO 2010 All rights reserved5 connection of piercing devices by hub, grip plate or tube 6 female Luer connector 3.2 Design for a transfer set with housing The design of a tr