欢迎来到麦多课文档分享! | 帮助中心 海量文档,免费浏览,给你所需,享你所想!
麦多课文档分享
全部分类
  • 标准规范>
  • 教学课件>
  • 考试资料>
  • 办公文档>
  • 学术论文>
  • 行业资料>
  • 易语言源码>
  • ImageVerifierCode 换一换
    首页 麦多课文档分享 > 资源分类 > PDF文档下载
    分享到微信 分享到微博 分享到QQ空间

    EN ISO 10555-6-2017 en Intravascular catheters - Sterile and single-use catheters - Part 6 Subcutaneous implanted ports.pdf

    • 资源ID:724118       资源大小:945.41KB        全文页数:28页
    • 资源格式: PDF        下载积分:10000积分
    快捷下载 游客一键下载
    账号登录下载
    微信登录下载
    二维码
    微信扫一扫登录
    下载资源需要10000积分(如需开发票,请勿充值!)
    邮箱/手机:
    温馨提示:
    如需开发票,请勿充值!快捷下载时,用户名和密码都是您填写的邮箱或者手机号,方便查询和重复下载(系统自动生成)。
    如需开发票,请勿充值!如填写123,账号就是123,密码也是123。
    支付方式: 支付宝扫码支付    微信扫码支付   
    验证码:   换一换

    加入VIP,交流精品资源
     
    账号:
    密码:
    验证码:   换一换
      忘记密码?
        
    友情提示
    2、PDF文件下载后,可能会被浏览器默认打开,此种情况可以点击浏览器菜单,保存网页到桌面,就可以正常下载了。
    3、本站不支持迅雷下载,请使用电脑自带的IE浏览器,或者360浏览器、谷歌浏览器下载即可。
    4、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。
    5、试题试卷类文档,如果标题没有明确说明有答案则都视为没有答案,请知晓。

    EN ISO 10555-6-2017 en Intravascular catheters - Sterile and single-use catheters - Part 6 Subcutaneous implanted ports.pdf

    1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Intravascular catheters - Sterile and single-use cathetersPart 6: Subcutaneous implanted ports (ISO 10555-6:2015)BS EN ISO 10555-6:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10555-6 August 2017 ICS 11.

    2、040.25 English Version Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)Cathters intravasculaires - Cathters striles et non rutilisables - Partie 6: Chambres cathter implantables (ISO 10555-6:2015) Intravaskulre Katheter - Sterile Ka

    3、theter zur einmaligen Verwendung - Teil 6: Subkutan implantierte Ports (ISO 10555-6:2015) This European Standard was approved by CEN on 30 July 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status

    4、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 European Standard exists in three official versions (English, French, Germa

    5、n). 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 are the national standards bodies of Austria, Belgium, Bulgaria, Croatia,

    6、 Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey a

    7、nd United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref.

    8、No. EN ISO 10555-6:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 105556:2017. It is identical to ISO 105556:2015. It supersedes BS ISO 105556:2015, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/205, Nonactive medi

    9、cal devices.A list of organizations represented on this committee can be obtained on 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. The British Standards Institution 2017 Published b

    10、y BSI Standards Limited 2017ISBN 978 0 580 95653 9ICS 11.040.25Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2015.Amendments/corrigenda issued since p

    11、ublicationDate Text affected31 December 2017 This corrigendum renumbers BS ISO 105556:2015 as BS EN ISO 105556:2017BRITISH STANDARDBS EN ISO 105556:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10555-6 August 2017 ICS 11.040.25 English Version Intravascular catheters - Sterile and sin

    12、gle-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)Cathters intravasculaires - Cathters striles et non rutilisables - Partie 6: Chambres cathter implantables (ISO 10555-6:2015) Intravaskulre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 6: Subkutan implantierte

    13、 Ports (ISO 10555-6:2015) This European Standard was approved by CEN on 30 July 2017. CEN members are bound to 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

    14、and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC 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 th

    15、e 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 are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugos

    16、lav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT

    17、EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10555-6:2017 EBS EN ISO 105556:2017EN ISO 10555-6:201

    18、7 (E) 3 European foreword The text of ISO 10555-6:2015 has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and catheters” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 10555-6:2017 by Technical Committee

    19、 CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. 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 February 2018, and conflicting national standards shall be withdra

    20、wn at the latest by February 2018. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN by th

    21、e European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA which is an integral part of this document. The following referenced documents are indispensable for the application

    22、of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced doc

    23、ument has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and oth

    24、erwise to the dated version of the ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. Table Correlation between normative references and dated EN and ISO standards

    25、 Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 10555-1:2013 EN ISO 10555-1:2013 ISO 10555-1:2013 ISO 10555-3:2013 EN ISO 10555-3:2013 ISO 10555-3:2013 BS EN ISO 105556:2017EN ISO 10555-6:2017 (E) 4 According to the CEN-CENELEC Internal Reg

    26、ulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland,

    27、Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10555-6:2015 has been approved by CEN as EN ISO 10555-6:2017 without any modification

    28、. BS EN ISO 105556:2017EN ISO 10555-6:2017 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of Directive 93/42/EEC OJ L 169 aimed to be covered This European standard has been prepared under a Commissions standardisation request M/295 concerning

    29、 the development of European Standards related to medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under

    30、 that Directive, compliance with the normative clauses of this standard given in Table 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. NOTE 1 Where a reference

    31、 from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or remov

    32、ed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references according

    33、to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Annex I of Dir

    34、ective 93/42/EEC OJ L 169 Essential Requirements (ER) of Directive 93/42/EEC Clause(s) / sub-clause(s) of this EN Remarks / Notes 7.5 4.2 ER 7.5 is covered only in respect of biocompatibility. Covers lubricants limited size drops on surfaces in design and manufacturing. 9.1 4.5.3, 4.5.6.1, 6.4 g) ER

    35、 9.1 is covered by Standard Clause 4.5.3 in respect of leakage only. ER 9.1 is covered by Standard Clause 4.5.6.1 only in respect of peak tensile force between the port and the catheter. ER 9.1 is covered by Standard Clause 6.4g only in respect of specifications of the devices required to connect th

    36、e port to the power injector. The connection must be standardized. The maximum for the connected injector. The intended purpose should be stated on the label BS EN ISO 105556:2017EN ISO 10555-6:2017 (E) 6 Essential Requirements (ER) of Directive 93/42/EEC Clause(s) / sub-clause(s) of this EN Remarks

    37、 / Notes or in the instruction for use, if not obvious. A pressure limit and maximum flowrate is required in the instruction for use, if the catheter is indicated for power injection. Covers restrictions on use indicated on labelling. 9.2 4.5.3, 4.5.4, 4.6, 4.7, 5 ER 9.2 first dash is covered by Sta

    38、ndard Clause 4.5.3 in respect of leakage only. ER 9.2 first dash is covered by Standard Clause 4.5.4 in respect of the flushing volume only. ER 9.2 first dash is covered by Standard Clause 4.6 in respect of the flow rate only. ER 9.2 first dash is covered by Standard Clause 4.7 in respect of the bur

    39、st pressure. ER 9.2 second dash is covered by Standard Clause 5 in respect of MRI compatibility only. The risk of injury, in connection with physical features including the volume/pressure ratio and dimensional features in the design process. 12.7.1 4.5.3, 4.6.2, 4.7.2 ER 12.7.1 is covered by Standa

    40、rd Clause 4.5.3 in respect of leakage only. ER 12.7.1 is covered by Standard Clause 4.6.2 in respect of flow rate only. ER 12.7.1 is covered by Standard Clause 4.7.2 in respect of burst pressure only. The catheter and port must be designed to protect the patient. 12.9 4.3 ER 12.9 is covered in respe

    41、ct of distance marking on the catheter only. Indicators for length adjustment. 13.3 a) 6.3 Standard Clause 6.3 first dash covers ER 13.3 a) but only in respect of the name of the manufacturer and only provided the labels are located as required by the Directive. 13.3 b) 6.1, 6.3 Standard Clause 6.1

    42、covers ER 13.3 b) only in respect of the marking on the actual product. Standard Clause 6.3 second and third dash covers ER 13.3 b) but only in respect of the designation and item number and Batch/Lot/serial number. 13.3 d) 6.3 ER 13.3 d) is covered by Standard Clause 6.3 third dash but only when th

    43、e any batch code is preceded by the word LOT. Label and traceability label 13.4 6.2, 6.4 ER 13.4 is covered by Standard Clause 6.2 but only in respect of identification of power injection. BS EN ISO 105556:2017EN ISO 10555-6:2017 (E) 7 Essential Requirements (ER) of Directive 93/42/EEC Clause(s) / s

    44、ub-clause(s) of this EN Remarks / Notes ER 13.4 is covered by Standard Clause 6.2 but only in respect of the information given in Standard Clause 6.4 a-g. 13.6 a) 6.4 13.6 b) 6.4 Only covers devices for power injection. 13.6 c) 6.4 g) 13.6 d) 6.4 c), d) 13.6 e) 6.4 a) 13.6 f) 6.4 e) 13.6 i) 6.4 g) 1

    45、3.6 l) 6.4 e) Precautions to be taken as regards exposure in reasonably foreseeable environmental conditions to magnetic fields. 13.6 n) 6.4 Does not specify unusual risk. 13.6 q) 6.4 WARNING 1: Presumption of conformity stays valid only as long as a reference to this European standard is maintained

    46、 in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this stan

    47、dard. BS EN ISO 105556:2017ISO 10555-6:2015(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements of the implantable subcutaneous implanted port and catheter . 34.1 General . 34.2 Biocompatibility 44.3 Distance markings 44.4 Nominal dimensions of the subcutaneous

    48、implanted port 44.5 Physical requirements 44.5.1 Radio-detectability . 44.5.2 Surface finish . 44.5.3 Freedom from leakage 44.5.4 Flushing volume . 44.5.5 Characteristics of the septum . 54.5.6 Characteristics of the connection or the catheter . 54.6 Flow rate . 54.6.1 Subcutaneous implanted ports n

    49、ot indicated for power injection . 54.6.2 Subcutaneous implanted ports indicated for power injection . 54.7 Burst pressure of the subcutaneous implanted port and catheter 64.7.1 Subcutaneous implanted ports not indicated for power injection . 64.7.2 Subcutaneous implanted ports indicated for power injection . 65 Magnetic Resonance Imaging (MRI) compatibility . 66 Information to be supplied by the manufacturer . 66.1 Marking on the device 66.2 Primary packaging . 66.3 Labels for traceability . 76.4 Instruction fo


    注意事项

    本文(EN ISO 10555-6-2017 en Intravascular catheters - Sterile and single-use catheters - Part 6 Subcutaneous implanted ports.pdf)为本站会员(syndromehi216)主动上传,麦多课文档分享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,请立即通知麦多课文档分享(点击联系客服),我们立即给予删除!




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

    copyright@ 2008-2019 麦多课文库(www.mydoc123.com)网站版权所有
    备案/许可证编号:苏ICP备17064731号-1 

    收起
    展开