欢迎来到标准图书馆! | 帮助中心 Day Day UP!
标准图书馆
首页 标准图书馆 > 资源分类 > PDF文档下载

ISO 8362-7-2006

  • 资源大小:194.35KB        全文页数:8页
  • 资源格式: PDF        下载权限:游客/注册会员/VIP会员    下载费用:30Gold 【人民币30元】
游客快捷下载 游客一键下载
会员登录下载
下载资源需要30Gold 【人民币30元】Paypal charge shall be login

邮箱/手机号:
您支付成功后,系统会自动为您创建此邮箱/手机号的账号,密码跟您输入的邮箱/手机号一致,以方便您下次登录下载和查看订单。注:支付完成后需要自己下载文件,并不会自动发送文件哦!

支付方式: 微信支付    支付宝   
验证码:   换一换

友情提示
2、本站资源不支持迅雷下载,请使用浏览器直接下载(不支持QQ浏览器)
3、本站资源下载后的文档和图纸-无水印,预览文档经过压缩,下载后原文更清晰   

ISO 8362-7-2006

Reference numberISO 8362-72006EISO 2006INTERNATIONAL STANDARD ISO8362-7Second edition2006-04-15Injection containers and accessories Part 7 Injection caps made of aluminium-plastics combinations without overlapping plastics part Rcipients et accessoires pour produits injectables Partie 7 Capsules dinjection en combinaison aluminium-plastique avec lment plastique non dbordant ISO 8362-72006E PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing 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 Central 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 taken 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 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced 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 01 11 Fax 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 – All rights reservedISO 8362-72006E ISO 2006 – All rights reserved iiiForeword 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 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, 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 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. 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 8362-7 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 8362-71995, of which it constitutes a minor revision. ISO 8362 consists of the following parts, under the general title Injection containers and accessories ⎯ Part 1 Injection vials made of glass tubing ⎯ Part 2 Closures for injection vials ⎯ Part 3 Aluminium caps for injection vials ⎯ Part 4 Injection vials made of moulded glass ⎯ Part 5 Freeze drying closures for injection vials ⎯ Part 6 Caps made of aluminium-plastics combinations for injection vials ⎯ Part 7 Injection caps made of aluminium-plastics combinations without overlapping plastics part ISO 8362-72006E iv ISO 2006 – All rights reservedIntroduction The materials from which injection containers including elastomeric closures are made are suitable primary packaging materials for storing injectable products until they are administered. However, in this part of ISO 8362, injection caps are not considered as primary packaging materials in direct contact with pharmaceutical preparations. During the processing of injection vials 2R and 4R, according to ISO 8362-1, and injection vials 6R, 8R, 10I, 5H, 7H and 8H, according to ISO 8362-1 and ISO 8362-4 respectively, difficulties may arise when using injection caps made of aluminium-plastics combinations corresponding to ISO 8362-6 because the diameter d2of the plastics element is larger than the diameter d of the injection vial body. In order to avoid problems during the automatic working process, e.g. labelling of the vials or intermediate storage on a turntable, injection caps made of aluminium-plastics combinations are designed in such a way that the plastics element does not overlap the diameter of the vial body. INTERNATIONAL STANDARD ISO 8362-72006E ISO 2006 – All rights reserved 1Injection containers and accessories Part 7 Injection caps made of aluminium-plastics combinations without overlapping plastics part 1 Scope This part of ISO 8362 specifies aluminium-plastics combinations for the injection caps of injection vials, as specified in ISO 8362-1 and ISO 8362-4, where the plastics part does not overlap the diameter of the vial body. 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 2768-1, General tolerances Part 1 Tolerances for linear and angular dimensions without individual tolerance indications ISO 2768-2, General tolerances Part 2 Geometrical tolerances for features without individual tolerance indications ISO 7500-1, Metallic materials Verification of static uniaxial testing machines Part 1 Tension/compression testing machines Verification and calibration of the force-measuring system ISO 8362-12003, Injection containers and accessories Part 1 Injection vials made of glass tubing ISO 8362-3, Injection containers and accessories Part 3 Aluminium caps for injection vials ISO 8362-42003, Injection containers and accessories Part 4 Injection vials made of moulded glass ISO 8362-6, Injection containers for injectables and accessories Part 6 Caps made of aluminium-plastics combinations for injection vials ISO 88722003, Aluminium caps for transfusion, infusion and injection bottles General requirements and test methods 3 Classification of types Injection caps shall be classified as follows ⎯ Type OB Aluminium cap with central opening, and without overlapping plastics component; ⎯ Type OD Aluminium cap with complete tear-off tab, and without overlapping plastics component. BS EN ISO 8362-72010ISO 8362-72006E 2 ISO 2006 – All rights reserved4 Dimensions and tolerances 4.1 Dimensions All cover versions flat, ring-shaped or other of injection caps shall meet the dimensions given in Figure 1 and Table 1. The dimensions of injection vials made of glass tubing shall be in accordance with ISO 8362-12003, Clause 4. The dimensions of injection vials made of moulded glass shall be in accordance with ISO 8362-42003, Clause 4. NOTE The configuration of the injection cap shown in Figure 1 is informative only. 4.2 Tolerances The tolerances shall be in accordance with ISO 2768-1 and ISO 2768-2. 5 Designation Aluminium-plastics injection caps shall be designated according to type the designation shall be expressed as the word “cap“, the number and part of this International Standard followed by the type letters, followed by the nominal size of the container. EXAMPLE A type OD aluminium-plastics injection cap of nominal size 13 complying with the requirements laid down in this part of ISO 8362 is designated Cap ISO 8362-7-OD-13 Dimensions in millimetres a Type OB b Type OD Key 1 plastics component 2 aluminium injection cap in accordance with ISO 8362-3 3 score line NOTE For dimensions of parameters, see Table 1. Figure 1 Configuration of injection cap Licensed Copy Mr. Universiti Teknologi Malaysia User, Universiti Teknologi Malaysia, 26/08/2012 0657, Uncontrolled Copy, c The British Standards Institution 2012BS EN ISO 8362-72010ISO 8362-72006E ISO 2006 – All rights reserved 3Table 1 Dimensions of injection cap Dimensions in millimetres Parameters d2ad3be ch1h2dNominal size d10,10min. max. min. max. min. max. 0,2 min. max. 13 13,3 13 15,8 3 8 6,3 7,3 8,4 20 20,3 20 20,9 6 10 0,168 0,242 7,3 8,7 9,8 aThe diameter d2shall be agreed between the manufacturer and user. It shall not differ from the nominal value by more than 0,25 mm. The extreme limits are given without tolerance. bAfter plastics element removal. The diameter d3shall be agreed between the manufacturer and user. cThe thickness e shall be agreed between the manufacturer and user. It shall not differ from the nominal value by more than 0,022 mm. The extreme limits are given without tolerance. dThe height h2shall be agreed between the manufacturer and user. It shall not differ from the nominal value by more than 0,3 mm. The extreme limits are given without tolerance. 6 Requirements 6.1 General requirements The requirements shall be in accordance with ISO 8362-6, with the exception of the force required to remove the plastics component and tear off the tab completely, and the corresponding test. 6.2 Force required to remove plastics component and tear off tab completely 6.2.1 The force required to remove the plastics component and tear off the tab completely is determined in a traction/pressure test machine class 1, in accordance with ISO 7500-1, with a special attachment as shown for example in Figure 2, with a traction speed, v, of 100 mm/min over a measuring range of 100 N. The values shall be in accordance with Tables 2 and 3. 6.2.2 For incoming control of as-received injection caps, the minimum value for the tear-off tab removal force shall be agreed between the supplier and user. The injection caps shall also withstand a sterilization process in accordance with ISO 88722003, 5.1. 7 Packaging Packaging shall comply with the requirements of ISO 8872. 8 Marking Marking shall be in accordance with ISO 8872 and the designation shall be as specified in Clause 5. Licensed Copy Mr. Universiti Teknologi Malaysia User, Universiti Teknologi Malaysia, 26/08/2012 0657, Uncontrolled Copy, c The British Standards Institution 2012BS EN ISO 8362-72010ISO 8362-72006E 4 ISO 2006 – All rights reserveda Test set up b Placement of pressure bar c Pressure bar Key 1 pressure bar 2 clamp jaws 3 direction of tractive force 4 bottle 5 aluminium injection cap 6 plastics component Figure 2 Example of equipment to determine force required to remove plastics component and tear off tab completely Table 2 Dimensions of pressure bar Dimensions in millimetresNominal size r b 13 5 8 20 9 10 Table 3 Force required to remove plastics component and tear off tab completely Force in newtonsNominal size Force required to remove plastics component max. Force required to tear off tab completely max. 13 25 30 20 35 40 Licensed Copy Mr. Universiti Teknologi Malaysia User, Universiti Teknologi Malaysia, 26/08/2012 0657, Uncontrolled Copy, c The British Standards Institution 2012

注意事项

本文(ISO 8362-7-2006)为本站会员(Hero_good)主动上传,标准图书馆仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知标准图书馆(发送邮件至admin@stdlibrary.com或直接QQ联系客服),我们立即给予删除!

温馨提示:如果因为网速或其他原因下载失败请重新下载,重复下载不扣分。

关于我们 - 网站声明 - 网站地图 - 资源地图 - 友情链接 - 网站客服客服 - 联系我们

@copyright 2017-Stdlibrary All Rights Reserved.


收起
展开