BS PD ISO TR 19244-2014 Guidance on transition periods for standards developed by ISO TC 84 Devices for administration of medicinal products and catheters《ISO TC 84制定标准的过渡时期指南 医药产品和导管的管理设备》.pdf

1、BSI Standards Publication PD ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 Devices for administration of medicinal products and cathetersPD ISO/TR 19244:2014 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of ISO/TR 19244:

2、2014. The UK participation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes. 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

3、. Users are responsible for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 83514 8 ICS 11.040.01 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the

4、authority of the Standards Policy and Strategy Committee on 31 August 2014. Amendments issued since publication Date Text affectedPD ISO/TR 19244:2014 ISO 2014 Guidance on transition periods for standards developed by ISO/TC 84 Devices for administration of medicinal products and catheters Directive

5、s relatives aux priodes de transition concernant les normes dveloppes par lISO/TC 84 Dispositifs dadministration de produits mdicinaux et cathters TECHNICAL REPORT ISO/TR 19244 First edition 2014-08-15 Reference number ISO/TR 19244:2014(E)PD ISO/TR 19244:2014ISO/TR 19244:2014(E)ii ISO 2014 All right

6、s reserved COPYRIGHT PROTECTED DOCUMENT ISO 2014 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prio

7、r written permission. Permission can be requested 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 Switzer

8、landPD ISO/TR 19244:2014ISO/TR 19244:2014(E) ISO 2014 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 T erms and definitions . 1 3 Recommendations for implementing ISO/TC 84 standards . 1 3.1 Marketed devices (Grandfathering) 1 3.2 Non-marketed devices 2 3.3 Rationale

9、for the transition period 2 Bibliography 3PD ISO/TR 19244:2014ISO/TR 19244:2014(E) Foreword 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 throu

10、gh 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 collabora

11、tes closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval c

12、riteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives Attention is drawn to the possibility that some of the elements of this document may be the subject of p

13、atent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patents Any trade name used in

14、 this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barrie

15、rs to Trade (TBT), see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 84, Devices for administration of medicinal products and intravascular catheters.iv ISO 2014 All rights reservedPD ISO/TR 19244:2014ISO/TR 19244:2014(E) Introduction T

16、his Technical Report outlines an ISO/TC 84 recommended transition period for newly published standards. It describes the recommended plan and the rationale for transitioning from “old versions” or “outdated” standards, which have been updated or replaced by new ISO/TC 84 standards. It addresses the

17、concepts of “Grandfathering” and “Transition Periods” relative to compliance requirements with new standards. When new International Standards are issued, the standard is valid from the date of publication. When new versions of existing International Standards are issued, the new standard is valid f

18、rom the date of publication and the previous version of the standard is withdrawn. In certain cases, the previous version can still be valid for a certain period of time. As a new standard does not specify any transition period, this report provides guidance on code of conduct in relation to impleme

19、nting standards in manufacturing medical devices covered by ISO/TC 84 standards. New or revised standards might influence both development of new products or need for changes of marketed devices. Both issues are addressed in this report. The intent of the transition period is to allow a reasonable a

20、mount of time for the development of the resources and test method/validation and documentation time to meet the new requirements and to fulfil the entire approval process. The transition period also includes sufficient time for the manufacturer to work with a Notified Body (and in turn, Competent A

21、uthorities) to approve this change. NOTE There can be legal or regulatory requirements that take precedence over the recommendations in this Technical Report. ISO 2014 All rights reserved vPD ISO/TR 19244:2014PD ISO/TR 19244:2014Guidance on transition periods for standards developed by ISO/TC 84 Dev

22、ices for administration of medicinal products and catheters 1 Scope This Technical Report outlines the recommended transition plans for all the TC 84 standards: Needle-based Injection systems ISO 11608 (all parts); Sharps Injury Protection (ISO 23908); Sharps Containers (ISO 23907), Aerosol Drug Del

23、ivery Devices (ISO 20072); Needle-free injection systems (ISO 21649); Syringes ISO 7886 (all parts), ISO 8537, ISO 9626; Needles (ISO 6009, ISO 7864); Intravascular Catheters and Ports ISO 10555 (all parts), ISO 11070. 2 T erms a nd definiti ons For the purposes of this document, the following terms

24、 and definitions apply. 2.1 grandfathering acceptance of no need for changes to a marketed device that has exhibited no safety or performance issues, without meeting the latest version of an ISO/TC 84 standard 2.2 transition period timeframe from the date of publication of a new ISO/TC 84 standard t

25、o when a manufacturer should no longer claim compliance with a previous version of the standard when marketing a new device or a device with a significant design change 2.3 s i g n i f i c a n t d e s i g n c h a n g e modification of the product, which either modifies essential performance and/or i

26、ntroduces new risks that need to be assessed 3 Recommendations for implementing ISO/TC 84 standards 3.1 Marketed devices (Grandfathering) A marketed device does not need to meet the requirements of a new or revised ISO/TC 84 standard. This is referred to as the “grandfather” clause, or “grandfathere

27、d” devices. TECHNICAL REPORT ISO/TR 19244:2014(E) ISO 2014 All rights reserved 1PD ISO/TR 19244:2014ISO/TR 19244:2014(E) In cases where: a) sufficient post-market safety and quality data exist and demonstrate that performance of the devices is acceptable in relation to the issues addressed in the ne

28、w standards, and b) a risk assessment is updated at least annually showing no need for further risk control (see ISO 14971:2007, definition 2.19), the grandfathering concept applies. In cases where significant design changes to the marketed product are made, the grandfathering concept should not be

29、applied and it is recommended that a design verification is performed in accordance with the latest version of the ISO/TC 84 standard. 3.2 Non-marketed devices It is recommended that non-marketed devices are designed to meet the requirements of the latest edition of the applicable ISO/TC 84 standard

30、s. However, this will not be possible in all cases and it is recommended that new-marketed devices comply with the new standard no later than three years after its publication. Beyond that point, a Notified Body or regulator should not accept a manufacturers desire to release new products referring

31、to the previous version of the applicable ISO/TC 84 standard. 3.3 Rationale for the transition period The rationale for this transition period is to enable: a marketed device, which may not meet the latest version of applicable ISO/TC 84 standards, to nonetheless stay on the market, as long as the c

32、onditions in 3.1 are met; non-marketed devices to be released to the market without fulfilling the requirements of newly published ISO/TC 84 standards.2 ISO 2014 All rights reservedPD ISO/TR 19244:2014ISO/TR 19244:2014(E) Bibliography 1 ISO 6009, Hypodermic needles for single use Colour coding for i

33、dentification 2 ISO 7864, Sterile hypodermic needles for single use 3 ISO 7886 (all parts), Sterile hypodermic syringes for single use 4 ISO 8537, Sterile single-use syringes, with or without needle, for insulin 5 ISO 9626, Stainless steel needle tubing for the manufacture of medical devices 6 ISO 1

34、0555 (all parts), Intravascular catheters Sterile and single-use catheters 7 ISO 11070, Sterile single-use intravascular introducers, dilators and guidewires 8 ISO 11608 (all parts), Needle-based injection systems for medical use Requirements and test methods 9 ISO 14971:2007, Medical devices Applic

35、ation of risk management to medical devices 10 ISO 20072, Aerosol drug delivery device design verification Requirements and test methods 11 ISO 21649, Needle-free injectors for medical use Requirements and test methods 12 ISO 23907, Sharps injury protection Requirements and test methods Sharps conta

36、iners 13 ISO 23908, Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling ISO 2014 All rights reserved 3PD ISO/TR 19244:2014ISO/TR 19244:2014(E) ISO 2014 All rights reserved I

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