1、BSI Standards PublicationPD ISO/TR 19244:2014Guidance on transition periodsfor standards developedby ISO/TC 84 Devices foradministration of medicinalproducts and cathetersPD ISO/TR 19244:2014 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of ISO/TR19244:2014.The
2、UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are res
3、ponsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 83514 8ICS 11.040.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authority of theStanda
4、rds Policy and Strategy Committee on 31 August 2014.Amendments issued since publicationDate Text affectedPD ISO/TR 19244:2014 ISO 2014Guidance on transition periods for standards developed by ISO/TC 84 Devices for administration of medicinal products and cathetersDirectives relatives aux priodes de
5、transition concernant les normes dveloppes par lISO/TC 84 Dispositifs dadministration de produits mdicinaux et cathtersTECHNICAL REPORTISO/TR19244First edition2014-08-15Reference numberISO/TR 19244:2014(E)PD ISO/TR 19244:2014ISO/TR 19244:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCU
6、MENT ISO 2014All 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 prior written permission. Permission can
7、 be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandPD ISO/TR 19244:2014ISO/TR 19244:2014(E
8、) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Terms and definitions . 13 Recommendations for implementing ISO/TC 84 standards . 13.1 Marketed devices (Grandfathering) 13.2 Non-marketed devices 23.3 Rationale for the transition period 2Bibliography 3PD ISO/TR 19
9、244:2014ISO/TR 19244:2014(E)ForewordISO (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
10、 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 Comm
11、ission (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 criteria needed for the different types of ISO documents s
12、hould be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directivesAttention 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 identi
13、fying 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/patentsAny trade name used in this document is information given for the convenience of
14、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 Barriers to Trade (TBT), see the following URL: Foreword - Supplem
15、entary informationThe 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)IntroductionThis Technical Report outlines an ISO/TC 84 recommended transiti
16、on 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 concepts of “Grandfathering” and “Transition Periods” relative
17、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 from the date of publication and the previous version of the stan
18、dard 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 implementing standards in manufacturing medical devices covered by ISO/T
19、C 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 amount of time for the development of the resources and test method/
20、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 Authorities) to approve this change.NOTE There can be legal or regula
21、tory 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 Devices for administration of medicinal products and catheters1 ScopeThi
22、s 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 Delivery Devices (ISO 20072); Needle-free injection systems (ISO 21649); S
23、yringes ISO 7886 (all parts), ISO 8537, ISO 9626; Needles (ISO 6009, ISO 7864); Intravascular Catheters and Ports ISO 10555 (all parts), ISO 11070.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1grandfatheringacceptance of no need for changes to
24、 a marketed device that has exhibited no safety or performance issues, without meeting the latest version of an ISO/TC 84 standard2.2transition periodtimeframe from the date of publication of a new ISO/TC 84 standard to when a manufacturer should no longer claim compliance with a previous version of
25、 the standard when marketing a new device or a device with a significant design change2.3significant design changemodification of the product, which either modifies essential performance and/or introduces new risks that need to be assessed3 Recommendations for implementing ISO/TC 84 standards3.1 Mar
26、keted 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 “grandfathered” devices.TECHNICAL REPORT ISO/TR 19244:2014(E) ISO 2014 All rights reserved 1PD ISO/TR 19244:2014ISO/TR 19
27、244:2014(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 new standards, andb) a risk assessment is updated at least annually showing no need for further risk control (see
28、 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 applied and it is recommended that a design verification is performed in accordance with the latest version of the
29、 ISO/TC 84 standard.3.2 Non-marketed devicesIt is recommended that non-marketed devices are designed to meet the requirements of the latest edition of the applicable ISO/TC 84 standards. However, this will not be possible in all cases and it is recommended that new-marketed devices comply with the n
30、ew 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 to the previous version of the applicable ISO/TC 84 standard.3.3 Rationale for the transition periodThe rationale fo
31、r 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 conditions in 3.1 are met; non-marketed devices to be released to the market without fulfilling the requirements of new
32、ly published ISO/TC 84 standards.2 ISO 2014 All rights reservedPD ISO/TR 19244:2014ISO/TR 19244:2014(E)Bibliography1 ISO 6009, Hypodermic needles for single use Colour coding for identification2 ISO 7864, Sterile hypodermic needles for single use3 ISO 7886 (all parts), Sterile hypodermic syringes fo
33、r single use4 ISO 8537, Sterile single-use syringes, with or without needle, for insulin5 ISO 9626, Stainless steel needle tubing for the manufacture of medical devices6 ISO 10555 (all parts), Intravascular catheters Sterile and single-use catheters7 ISO 11070, Sterile single-use intravascular intro
34、ducers, dilators and guidewires8 ISO 11608 (all parts), Needle-based injection systems for medical use Requirements and test methods9 ISO 14971:2007, Medical devices Application of risk management to medical devices10 ISO 20072, Aerosol drug delivery device design verification Requirements and test
35、methods11 ISO 21649, Needle-free injectors for medical use Requirements and test methods12 ISO 23907, Sharps injury protection Requirements and test methods Sharps containers13 ISO 23908, Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic need
36、les, 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 reservedICS 11.040.01Price based on 3 pagesThis page deliberately left blankBSI is the national body responsible for preparing British Standar
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