DIN EN ISO 15747-2012 Plastic containers for intravenous injections (ISO 15747 2010) German version EN ISO 15747 2011《静脉注射用塑料容器(ISO 15747-2010) 德文版本EN ISO 15747-2011》.pdf

1、July 2012 Translation by DIN-Sprachendienst.English price group 11No 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 1

2、1.040.25!$9K“1902240www.din.deDDIN EN ISO 15747Plastic containers for intravenous injections (ISO 15747:2010)English translation of DIN EN ISO 15747:2012-07Kunststoffbehltnisse fr intravense Injektionen (ISO 15747:2010)Englische bersetzung von DIN EN ISO 15747:2012-07Rcipients en plastique pour inje

3、ctions intraveineuses (ISO 15747:2010)Traduction anglaise de DIN EN ISO 15747:2012-07SupersedesDIN EN ISO 15747:2010-08www.beuth.deDocument comprises 21 pagesIn case of doubt, the German-language original shall be considered authoritative.06.12 DIN EN ISO 15747:2012-07 2 A comma is used as the decim

4、al marker. National foreword This standard has been prepared by Technical Committee 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

5、devices” (Secretariat: DIN, Germany). The responsible German body involved in its 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 Interna

6、tional Standards referred to in this document are as follows: ISO 8536-4 DIN EN ISO 8536-4 ISO 2859-1 DIN ISO 2859-1 ISO 10993 (all parts) DIN EN ISO 10993 Amendments This standard differs from DIN EN ISO 15747:2010-08 as follows: a) Annex ZA has been revised. Previous editions DIN 58363-15: 1982-07

7、, 1996-11 DIN EN ISO 15747: 2005-06, 2010-08 National Annex NA (informative) Bibliography DIN EN ISO 8536-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed DIN ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acce

8、ptance quality limit (AQL) for lot-by-lot inspection DIN EN ISO 10993 (all parts), Biological evaluation of medical devices EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15747 October 2011 ICS 11.040.20 Supersedes EN ISO 15747:2010English Version Plastic containers for intravenous injecti

9、ons (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 comply with the CEN/CENELEC Internal Regulations which

10、 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-CENELEC Management Centre or to any CEN member. This Euro

11、pean 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 the same status as the official versions. CEN members ar

12、e 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, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Swede

13、n, 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 any means reserved worldwide for CEN national Members. R

14、ef. No. EN ISO 15747:2011: EContents Page Foreword 3Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .5 4 Requirements.6 4.1 Physical

15、 requirements 6 4.2 Chemical requirements.7 4.3 Biological requirements8 5 Identification 9 6 Application of tests .9 Annex A (normative) Physical tests10 Annex B (normative) Chemical tests 13 Annex C (normative) Biological tests .16 Bibliography19 EN ISO 15747:2011 (E) DIN EN ISO 15747:2012-07 218F

16、oreword This document (EN ISO 15747:2011) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use“. This European Standard shall be given the status of a national standard, either by publication of an identical text or by e

17、ndorsement, 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 of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for ident

18、ifying 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 mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU D

19、irective. 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 national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulg

20、aria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice

21、 The text of ISO 15747:2010 has been approved by CEN as EN ISO 15747:2011 without any modification. EN ISO 15747:2011 (E) DIN EN ISO 15747:2012-073 Introduction In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take prec

22、edence over this International Standard. EN ISO 15747:2011 (E) DIN EN ISO 15747:2012-07 41 Scope This International Standard contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This International Standard is

23、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) solutions. 2 Normative references The following refer

24、enced 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, Sampling procedures for inspection by attributes Part 1:

25、 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 Terms and definitions For the purposes of this doc

26、ument, 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 evidence that the infusion container has been tamper

27、ed 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 the container that is used to hang it up EN ISO 157

28、47:2011 (E) DIN EN ISO 15747:2012-075 3.5 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 the storage and administration of the parenteral injection product 3.7 i

29、njection 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 the insertion part of the infusion device 3.9 nominal capacity intended

30、 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 Requirements 4.1 Physical requirements 4.1.1 Manufacturing process com

31、patibility 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 infusion container shall withstand alternating thermal stress, shall be

32、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 infusion container shall be sufficiently transparent so that suspended

33、 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. EN ISO 15747:2011 (E) DIN EN ISO 15747:2012-07 64.1.5 Water vapour permeability

34、 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 Permeability of other gases (e.g. oxygen) should be taken into account depending on the content of

35、 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 than 25 particles with a diameter W 10 m and no more than 3 particles with a diameter W 25

36、 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. 4.1.7 Cover The access port shall be protected by a cover. Its intactness is determined by vi

37、sual 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 specified in ISO 8536-4. The force shall not exceed 200 N at an insertion rate of 500 mmmin1,

38、 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 insertion part of an infusion device in accordance with ISO 8536-4, for sealing off the insertion

39、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 removal force shall be greater than 15 N. 4.1.10 Injection point If the container has an injec

40、tion 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 shall withstand a tensile load when tested as specified in A.11. 4.1.12 Identification The

41、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. Alter

42、natively, it may be tested as described in Table 1. EN ISO 15747:2011 (E) DIN EN ISO 15747:2012-077 Table 1 Requirements for the raw container or the sheeting Requirements Maximum permissible value Test as specified in Residue on ignition: polyolefins 5 mg/g polyvinyl chloride, containing plasticize

43、rs 1 mg/g B.2 Metals: Ba, Cd, Cr, Cu, Pb, Sn for each metal, 3 mg/kg B.3 4.2.2 Requirements for the test fluid The test fluid shall be prepared as specified in B.4. No coloration, but weak opalescence of the test fluid, is permissible. It shall fulfil the requirements specified in Table 2. Table 2 R

44、equirements for the test fluid Requirements Maximum permissible value Test as specified in Acidity or alkalinity 0,4 ml sodium hydroxide solution c(NaOH) = 0,01 mol/l 0,8 ml hydrochloric acid c(HCl) = 0,01 mol/l B.6 UV absorbance in the range of 230 nm to 360 nm: u 0,25 for infusion containers with

45、a nominal capacity u 100 ml u 0,2 for infusion containers with a nominal capacity 100 ml B.7 Evaporation residue 5 mg B.8 Oxidizable constituents 1,5 ml B.9 Ammonia 0,8 mg/l B.10 Metals: Ba, Cr, Cu, Pb Sn, Cd Al for each metal, 1 mg/l for each metal, 0,1 mg/l 0,05 mg/l B.11 Heavy metals 2 mg/l B.12

46、4.3 Biological requirements 4.3.1 Impermeability for microorganisms The infusion container shall be impermeable to microorganisms when tested as specified in C.2. 4.3.2 Migration/tolerance The materials used for the manufacture of infusion containers (e.g. films, wrappings, adhesives, adhesion promo

47、ters, printing inks) shall not release into the infusion solution any substances in such quantities that they have a pyrogenic or toxic effect when tested as specified in C.3, C.4 and the ISO 10993 series. EN ISO 15747:2011 (E) DIN EN ISO 15747:2012-07 85 Identification Identification shall be in accordance with the relevant laws and specifications. 6 Application of tests A distinction is made between type testing and batch testing. All tests specified in Annexes A to C are type testing. They shall be repeated if one or more of the following conditions is changed significantly so that the r