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1、INTERNATIONAL STANDARD ISO 15747 First edition 2003-11-15 Reference number ISO 15747:2003(E) ISO 2003 Plastics containers for intravenous injection Rcipients en plastique pour injections intraveineuses Copyright International Organization for Standardization Provided by IHS under license with ISO Li
2、censee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 23:39:16 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15747:2003(E) ii ISO 2003 All rights reserved PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensin
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5、aken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduc
6、ed or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749
7、01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 23:39:16 MDTNo reproduction or networ
8、king permitted without license from IHS -,-,- ISO 15747:2003(E) ISO 2003 All rights reserved iii Contents Page 1Scope 1 2Normative references 1 3Terms and definitions 1 4Requirements . 2 4.1Physical requirements 2 4.2Chemical requirements . 3 4.3Biological requirements . 4 5Identification 4 6Applica
9、tion of tests . 4 Annex A (normative) Physical tests . 6 Annex B (normative) Chemical tests 9 Annex C (normative) Biological tests . 12 Annex D (informative) Further biological tests 15 Bibliography . 16 Copyright International Organization for Standardization Provided by IHS under license with ISO
10、Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 23:39:16 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15747:2003(E) iv ISO 2003 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation o
11、f national standards bodies (ISO member bodies). The work of 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. In
12、ternational organizations, governmental and non-governmental, 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
13、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 technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval
14、 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. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15747 was prepared by Technical Committee
15、ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 23:39:16 MDTNo reproduction or networ
16、king permitted without license from IHS -,-,- ISO 15747:2003(E) ISO 2003 All rights reserved v Introduction In some countries, national or regional pharmacopoeia or other government regulations are legally binding and their requirements take precedence over this International Standard. Copyright Int
17、ernational Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 23:39:16 MDTNo reproduction or networking permitted without license from IHS -,-,- . vi Copyright International Organization for Standardizatio
18、n Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 23:39:16 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARDISO 15747:2003(E) ISO 2003 All rights reserved 1 Plastics containers for intrave
19、nous injection 1Scope This International Standard contains requirements related to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This International Standard is applicable to plastic containers for parenterals having one or more chambers an
20、d having a total nominal capacity in the range from to , such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. 2Normative references The following referenced documents are indispensable for the application of this document. For dated reference
21、s, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 8536-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed 3Terms and definitions For the purposes of this document, the
22、 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 which protects the access port during storage and also provides evidence if the infusion container has been tampered with NOT
23、EThe 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 which is used to hang it up 3.5 identification pap
24、er 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 50 ml5 000 ml Copyright International Organization for Standardiz
25、ation Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 23:39:16 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15747:2003(E) 2 ISO 2003 All rights reserved 3.7 injection point point for injecting pharmaceu
26、ticals NOTE 1The injection point and the insertion point can be identical. NOTE 2Some 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 or declared fluid volume of a container 3.10
27、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 4Requirements 4.1Physical requirements 4.1.1Manufacturing process compatibility The infusion container shall comply wi
28、th 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). 4.1.2Resistance to temperature, pressure and leakage The infusion container shall withstand alternating thermal stress, shall be resistant to pressure, and shall be leak-free when
29、 tested as specified in A.3. 4.1.3Resistance to dropping The infusion container shall sustain no damage after being dropped when tested as specified in A.4. 4.1.4Transparency The infusion container shall be sufficiently transparent so that suspended particles, turbidity and discoloration can be reco
30、gnized when tested as specified in A.5. 4.1.5Water vapour permeability Unless otherwise defined for specific applications or uses, the packed infusion container shall not lose more than of its mass during the period of usability, when tested as specified in A.6. 4.1.6Particulate contamination Infusi
31、on containers shall be manufactured so that contamination with particles is avoided. 5 % Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 23:39:16 MDTNo reproduction or networking
32、 permitted without license from IHS -,-,- ISO 15747:2003(E) ISO 2003 All rights reserved 3 When empty infusion containers are tested as specified in A.7, no more than 20 particles with a diameter shall be found per millilitre of nominal capacity. Finished parenteral solutions in the infusion contain
33、ers shall comply with relevant pharmacopoeial requirements for finished product particulate matter. 4.1.7Cover 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. 4.1.8Access port It
34、 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 at an insertion rate of when tested as specified in A.8. 4.1.9Adhesion strength of the infusion device and impermeability of the insertion point The m
35、aterial 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 point and for holding the insertion part firmly when subject to tensile load. When tested as specified in A.9, no leakage shall
36、occur and the insertion part shall not slide out from the insertion point. The removal force shall be greater than . 4.1.10Injection 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. 4.1.11Hanger It shall
37、be possible to hang up the infusion container when it is in use. The hanger shall withstand a tensile load when tested as specified in A.11. 4.1.12Identification The identification characters shall be clearly legible, and affixed labels shall not become detached when tested as specified in A.12. 4.2
38、Chemical requirements 4.2.1Requirements 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. Table 1 Requirements Maximum permissible value Test as specified in Residue on ignit
39、ion:B.2 Polyolefins Polyvinyl chloride containing plasticizers Metals: Ba, Cd, Cr, Cu, Pb, Snfor each metal, B.3 ?5,0m 200 N500 mmmin1 15 N 5 mg/g 1 mg/g 3 mg/kg Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/997254
40、5001 Not for Resale, 04/18/2007 23:39:16 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15747:2003(E) 4 ISO 2003 All rights reserved 4.2.2Requirements for the test fluid The test fluid shall be prepared as specified in B.4. No coloration, but weak opalescence of the te
41、st fluid is permissible. It shall fulfil the requirements specified in Table 2. 4.3Biological requirements 4.3.1Impermeability to microorganisms The infusion container shall be impermeable to microorganisms when tested as specified in C.2. 4.3.2Migration/tolerance The materials used for the manufact
42、ure of infusion containers (e.g. films, wrappings, adhesives, adhesion promoters, printing inks) shall not release to the infusion solution any substances in such quantities that they have a pyrogenic or toxic effect when tested as specified in C.3 and C.4. 5Identification Identification shall be in
43、 accordance with the relevant laws and specifications. Table 2 RequirementsMaximum permissible valueTesting as specified in Acidity or alkalinity sodium hydroxide solutionB.6 hydrochloric acid UV absorbancein the range from to B.7 for infusion containers with a nominal capacity for infusion containe
44、rs with a nominal capacity Evaporation residue or B.8 Oxidizable constituentsB.9 AmmoniaB.10 Metals:B.11 Ba, Cr, Cu, Pbfor each metal, Sn, Cdfor each metal, Al Heavy metalsB.12 0,4 ml c(NaOH)=0,01 mol/l 0,8 ml c(HCl)=0,01 mol/l 230 nm360 nm ?0,25 ?100 ml ?0,2 100 ml 5 mg50 mg/l 1,5 ml 0,8 mg/l 1 mg/
45、l 0,1 mg/l 0,05 mg/l 2 mg/l Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 23:39:16 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15747:2003(E) I
46、SO 2003 All rights reserved 5 6Application of tests A distinction is made between type testing and batch testing. All tests specified in Annexes A to D are type testing. They shall be repeated if one or more of the following conditions are changed significantly so that the requirements as specified
47、in Clause 4 might be affected: the design; the plastic composition; the process of manufacturing the infusion container; the sterilization process. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for R
48、esale, 04/18/2007 23:39:16 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15747:2003(E) 6 ISO 2003 All rights reserved Annex A (normative) Physical tests A.1General Physical testing shall be performed using an infusion container filled to its nominal capacity with infusion solution or with water. A.2Sampling Tak