ISO-15747-2003.pdf
《ISO-15747-2003.pdf》由会员分享,可在线阅读,更多相关《ISO-15747-2003.pdf(24页珍藏版)》请在三一文库上搜索。
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
3、g policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Ce
4、ntral Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been t
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
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- ISO 15747 2003
链接地址:https://www.31doc.com/p-3775565.html