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GHTF Glossary and Definition of Terms Used in GHTF Documents - PDF (163KB)

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GHTF Steering Committee Final Document GHTF/SC/N4:2012 (Edition 2)

Preface

The document herein was produced by the Global Harmonization Task Force, a voluntary

group of representatives from medical device regulatory agencies and the regulated industry.

The document is intended to provide non-binding guidance for use in the regulation of medical

devices, and has been subject to consultation throughout its development.

There are no restrictions on the reproduction, distribution or use of this document;

however, incorporation of this document, in part or in whole, into any other document, or its

translation into languages other than English, does not convey or represent an endorsement of

any kind by the Global Harmonization Task Force.

1.0 Introduction

The purpose of this document is to publish a list of definitions used in all GHTF Final

Documents for use as a GHTF Glossary of Terms.

2.0 Rationale, Purpose and Scope

GHTF guidance documents have been written by different Study Groups and, when

finalised, are published by the GHTF on its website. Many include a list of the definitions. This

particular document consolidates these definitions into a single list and will improve

understanding of the guidance provided in GHTF Final Documents.

3.0 References

All GHTF Final Documents.

4.0 Definitions

It should be noted that this document is intended as an information paper only and is not

intended to be a definitive dictionary of each term. In some instances there may be more than

one definition for a single term. Where this occurs it is recommended that the reader refer to the

source documents in which they are referenced to ensure the terms are understood in the correct

context. It should also be noted that some definitions are derived from international or national

standards, guidance or regulations. Where such definitions are used herein, it is recommended

that readers refer to the original source documents.

5.0 Existing Definitions in GHTF documents

Definitions, which appear in GHTF Final Documents, are listed in Appendix A.

When writing a new document or modifying an existing one, the relevant Study Group

should review the Glossary of Terms in the Appendix and use a definition from the list whenever

possible. When submitting a guidance document to the GHTF Steering Committee for

endorsement, the Study Group should confirm it has made the comparison and explain the reason

for incorporating an alternative to the listed definition.

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November 9 , 2012 Page 2 of 34

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