EN ISO 15747-2011 en Plastic containers for intravenous injections《静脉注射用塑料容器》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 15747:2011Plastic containers for intravenous injections (ISO 15747:2010)BS EN ISO 15747:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementa

2、tion of EN ISO 15747. It is identical to ISO 15747:2010. It supersedes BS EN ISO 15747:2010,which is withdrawn.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e C H / 2 1 2 , I V D s .A list of organizations represented on this committee can be obtained on

3、request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. BSI 2011 ISBN 978 0 580 76947 4 ICS 11.040.20 Compliance with a British Standard cannot confer immunity from legal obligations.This Bri

4、tish Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2011.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15747 October 2011 ICS 11.040.20 Supersedes EN ISO 15747:2010Engl

5、ish Version Plastic containers for intravenous injections (ISO 15747:2010) Rcipients en plastique pour injections intraveineuses (ISO 15747:2010) Kunststoffbehltnisse fr intravense Injektionen (ISO 15747:2010) This European Standard was approved by CEN on 20 September 2011. CEN members are bound to

6、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 references concerning such national standards may be obtained on application to the CEN-CEN

7、ELEC 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 member into its own language and notified to the CEN-CENELEC Management Centre has th

8、e same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Polan

9、d, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by an

10、y means reserved worldwide for CEN national Members. Ref. No. EN ISO 15747:2011: EBS EN ISO 15747:2011 EN ISO 15747:2011 (E) 3 Foreword This document (EN ISO 15747:2011) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical u

11、se“. 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 April 2012, and conflicting national standards shall be withdrawn at the latest by April 2012. Attention is drawn to the possibility that some

12、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 15747:2010. This new edition contains a revised Annex ZA. This document has been prepared under a mand

13、ate 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/CENELEC Internal Regulations, the n

14、ational standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlan

15、ds, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15747:2010 has been approved by CEN as EN ISO 15747:2011 without any modification. BS EN ISO 15747:2011EN ISO 15747:2011 (E) 4 Annex ZA (informative) Relat

16、ionship 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 European Free Trade Association to provide a means of conforming to Essential Re

17、quirements 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 implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Ta

18、ble 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 between this European Standard and Directive 93/42/EEC on medical devices Clause(s

19、)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes4.2, 4.3.2 7.1 Only chemical toxicity is addressed (in clause 4.2). Only pyrogenic and toxic effects are addressed (in clause 4.3.2). 4.1.4, 4.1.6, 4.2 7.2 The part of ER 7.2 regarding the packagin

20、g is not addressed. 4.1.2, 4.1.5, 4.2 7.3 Only the first half sentence of ER 7.3 is addressed. 4.1.2, 4.1.5, 4.2, 4.3.2 7.5 Only the first sentence of ER 7.5 is covered. 4.1.7 to 4.1.10, 4.3.1 7.6 4.1.7 to 4.1.11, 4.3.1 8.1 4.1.7 to 4.1.11 9.1 Restrictions indicated on the label or in the instructio

21、ns for use are not addressed. 4.1.2, 4.1.3 12.7.1 Only resistance to mechanical stress is addressed. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 15747:2011ISO 15747:2010(E) ISO 2010 All rights reserved ii

22、iContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Requirements.2 4.1 Physical requirements 2 4.2 Chemical requirements.3 4.3 Biological requirements4 5 Identification 5 6 Application of tests .5 Annex A (normative) Physical tests6 Annex B (normat

23、ive) Chemical tests 9 Annex C (normative) Biological tests .12 Bibliography14 BS EN ISO 15747:2011ISO 15747:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of

24、 preparing International Standards is normally carried out through ISO technical committees. Each member body interested 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

25、, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical 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

26、task of technical committees is to prepare International Standards. Draft International Standards adopted by the 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. Atten

27、tion 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 or all such patent rights. ISO 15747 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for

28、 medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 15747:2003), which has been technically revised. Especially Annex C was totally revised in order to refer to the International Standards of the ISO 10993 series, which specifies the biological assessment

29、 of medical products. BS EN ISO 15747:2011ISO 15747:2010(E) ISO 2010 All rights reserved vIntroduction In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this International Standard. BS EN ISO 15747:2

30、011BS EN ISO 15747:2011INTERNATIONAL STANDARD ISO 15747:2010(E) ISO 2010 All rights reserved 1Plastic containers for intravenous injections 1 Scope This International Standard contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containe

31、rs for parenterals. This International Standard is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) so

32、lutions. 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 referenced document (including any amendments) applies. ISO 2859-1, Sampl

33、ing procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO 8536-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed ISO 10993 (all parts), Biological evaluation of medical devices 3

34、 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 access port area of the infusion container consisting of the insertion point and the injection point, if applicable 3.2 cover part that protects the access port during storage and also provides e

35、vidence that the infusion container has been tampered with NOTE The cover can also envelop the entire container (e.g. outer bag). 3.3 empty container raw container with identification, which is suitable for the acceptance, storage and administration of the injection solution 3.4 hanger that part of

36、the container that is used to hang it up BS EN ISO 15747:2011ISO 15747:2010(E) 2 ISO 2010 All rights reserved3.5 identification paper or foil label or printing or embossing 3.6 infusion container container filled to its nominal capacity with parenteral injection product and with identification for t

37、he storage and administration of the parenteral injection product 3.7 injection point point for injecting pharmaceuticals NOTE 1 The injection point and the insertion point can be identical. NOTE 2 Some containers intentionally do not have an injection point. 3.8 insertion point point which accepts

38、the insertion part of the infusion device 3.9 nominal capacity intended or declared fluid volume of a container 3.10 raw container empty container that has not yet been sterilized and has no identification 3.11 sheeting plastic film, foil or sheeting intended for the production of empty containers 4

39、 Requirements 4.1 Physical requirements 4.1.1 Manufacturing process compatibility The infusion container shall comply with the requirements given in 4.1.2 to 4.1.5 and 4.1.7 to 4.1.10 after the manufacturing process (such as sterilization). 4.1.2 Resistance to temperature, pressure and leakage The i

40、nfusion container shall withstand alternating thermal stress, shall be resistant to pressure and shall be leak-free when tested as specified in A.3. 4.1.3 Resistance to dropping The infusion container shall sustain no damage after being dropped when tested as specified in A.4. 4.1.4 Transparency The

41、 infusion container shall be sufficiently transparent so that suspended particles, turbidity and discoloration can be recognised when tested as specified in A.5. Alternative procedures may be used. NOTE Blocking of UV radiation should be considered depending on the content of the container. BS EN IS

42、O 15747:2011ISO 15747:2010(E) ISO 2010 All rights reserved 34.1.5 Water vapour permeability Unless otherwise defined for specific applications or uses, the packed infusion container shall not lose more than 5 % of its mass during the period of usability, when tested as specified in A.6. NOTE Permeab

43、ility of other gases (e.g. oxygen) should be taken into account depending on the content of the container. 4.1.6 Particulate contamination Infusion containers shall be manufactured so that contamination with particles is avoided. When empty infusion containers are tested as specified in A.7, no more

44、 than 25 particles with a diameter W 10 m and no more than 3 particles with a diameter W 25 m shall be found per millilitre of nominal capacity. Finished parenteral solutions in the infusion containers shall comply with relevant pharmacopoeial requirements for finished product particulate matter. 4.

45、1.7 Cover The access port shall be protected by a cover. Its intactness is determined by visual inspection. It shall be possible to remove the cover without using mechanical aids. 4.1.8 Access port It shall be possible to pierce the insertion point with the insertion part of an infusion device as sp

46、ecified in ISO 8536-4. The force shall not exceed 200 N at an insertion rate of 500 mmmin1, when tested as specified in A.8. 4.1.9 Adhesion strength of the infusion device and impermeability of the insertion point The material and design of the access port shall be suitable for accepting the inserti

47、on part of an infusion device in accordance with ISO 8536-4, for sealing off the insertion point and for holding the insertion part firmly when subject to tensile load. When tested as specified in A.9 no leakage shall occur and the insertion part shall not slide out from the insertion point. The rem

48、oval force shall be greater than 15 N. 4.1.10 Injection point If the container has an injection point, this shall not leak after puncturing and removal of the cannula when tested as specified in A.10. 4.1.11 Hanger It shall be possible to hang the infusion container up when it is in use. The hanger

49、shall withstand a tensile load when tested as specified in A.11. 4.1.12 Identification The identification characters shall be clearly legible, and affixed labels shall not become detached when tested as specified in A.12. 4.2 Chemical requirements 4.2.1 Requirements for the raw container or the sheeting The sheeting shall fulfil the requirements given in the relevant pharmacopoeias. Alternatively, it may be tested as described in Table 1. BS EN ISO 15747:2011ISO 15747:2010(E) 4 ISO 2010 All rights reservedTable 1 Requirements for the raw