lossaryanddefinitionoftermsusedinghtfdocuments-.docVIP

GHTF/SC/N4:2012 (Edition 2) FINAL DOCUMENT (revision of GHTF/SC/N4: 2011) Title: Glossary and Definitions of Terms Used in GHTF Documents Authoring Group: GHTF Steering Committee Date: November 9th, 2012 Dr. Kazunari Asanuma, GHTF Chair This document was produced by the Global Harmonization Task Force, a voluntary international group of representatives from medical device regulatory authorities and trade associations from Europe, the United States of America (USA), Canada, Japan and Australia. The document is intended to provide non-binding guidance to regulatory authorities 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. Copyright ? 2012 by the Global Harmonization Task Force 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. 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. Rationale, Purpose and Scope GHTF guidance documen