ISO/TR 19244:2014

Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters

ISO/TR 19244:2014 outlines the recommended transition plans for all the TC 84 standards: Needle-based Injection systems; Sharps Injury Protection; Sharps Containers, Aerosol Drug Delivery Devices; Needle-free injection systems; Syringes; Needles; Intravascular Catheters and Ports.

Directives relatives aux périodes de transition concernant les normes développées par l'ISO/TC 84 — Dispositifs d'administration de produits médicinaux et cathéters

General Information

• Status: Published
• Publication Date: 06-Aug-2014
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: ISO/TC 84 - Devices for administration of medicinal products and catheters
• Drafting Committee: ISO/TC 84 - Devices for administration of medicinal products and catheters
• Current Stage: 6060 - International Standard published
• Start Date: 01-Aug-2014
• Completion Date: 07-Aug-2014

Standards Content (Sample)

TECHNICAL ISO/TR
REPORT 19244
First edition
2014-08-15
Guidance on transition periods for
standards developed by ISO/TC
84 — Devices for administration of
medicinal products and catheters
Directives relatives aux périodes de transition concernant les normes
développées par l’ISO/TC 84 — Dispositifs d’administration de
produits médicinaux et cathéters
Reference number
ISO/TR 19244:2014(E)
©
ISO 2014

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ISO/TR 19244:2014(E)

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
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ii © ISO 2014 – All rights reserved

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ISO/TR 19244:2014(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms 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 for the transition period . 2
Bibliography . 3
© ISO 2014 – All rights reserved iii

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ISO/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
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.
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 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
patent 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 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 ISO’s adherence to the WTO principles in the Technical Barriers
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 reserved

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ISO/TR 19244:2014(E)

Introduction
This 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 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 from the date
of publication and the previous version of the standard is wit
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