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DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Publisher

National Standards Authority of Ireland

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Foreword
Introduction
1 Scope
2 Classification of dental devices and accessories
3 Proposals for classification of dental devices
and accessories
Bibliography

Gives guidance on the application of the classification rules in Council Directive 93/42/EEC of 14 June 1993, amended by Directive 2007/47/EC, concerning medical devices as they pertain to dental devices and accessories.

DocumentType	Standard
Pages	12
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. CEN TR 12401:2003

Standards	Relationship
CEN/TR 12401:2009	Identical

EN 21942-1 : 1991	DENTAL VOCABULARY - GENERAL AND CLINICAL TERMS
EN 21942-2 : 1992	DENTAL VOCABULARY - DENTAL MATERIALS
EN 21942-4 : 1993	DENTAL VOCABULARY - DENTAL EQUIPMENT
2007/47/EC : 2007 COR 1 2015	DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
EN 1641:2009	Dentistry - Medical devices for dentistry - Materials
EN ISO 7405:2008/A1:2013	DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
EN 21942-3 : 1993	DENTAL VOCABULARY - DENTAL INSTRUMENTS
EN 1639:2009	Dentistry - Medical devices for dentistry - Instruments
EN 1642:2011	Dentistry - Medical devices for dentistry - Dental implants
EN 1640:2009	Dentistry - Medical devices for dentistry - Equipment
CEN ISO/TR 14969:2005	Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
ISO 1942-5:1989	Dental vocabulary Part 5: Terms associated with testing
EN ISO 14971:2012	Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

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S.R. CEN TR 12401:2009

DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory