CR 12401 : 1996

Name: CR 12401 : 1996
Brand: CEN

Superseded

View Superseded by

DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES

Superseded date

01-07-2003

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

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

Gives guidelines on the application of classification rules in Council Directive 93/42 EEC of 14 June 1993 relevant to medical devices as they apply to dental devices and accessories.

Committee	TC 55
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	CEN/TR 12401:2009

Standards	Relationship
PD CR 12401:2003	Identical
PD 6618:1997	Identical
SN CR 12401 : 1996	Identical
NEN CR 12401 : 1996	Identical
DIN V 13974:2003-10	Corresponds
NF CR 12401 : 97 FD	Identical
UNE-CR 12401:1997	Identical

02/563808 DC : DRAFT SEP 2002	BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
02/563845 DC : DRAFT SEP 2002	BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
05/30099256 DC : DRAFT MAY 2005	ISO 16059 - DENTISTRY - REQUIRED ELEMENTS FOR CODIFICATION USED IN DATA EXCHANGE
02/563832 DC : DRAFT SEP 2002	BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
ISO/TR 15300:2001	Dentistry Application of OSI clinical codification to the classification and coding of dental products
02/563818 DC : DRAFT SEP 2002	BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT

EN 21942-1 : 1991	DENTAL VOCABULARY - GENERAL AND CLINICAL TERMS
EN 21942-2 : 1992	DENTAL VOCABULARY - DENTAL MATERIALS
ISO 13488:1996	Quality systems — Medical devices — Particular requirements for the application of ISO 9002
EN ISO 13488 : 2000	QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
EN 21942-4 : 1993	DENTAL VOCABULARY - DENTAL EQUIPMENT
EN 46001 : 1996	QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
EN 724 : 1994	GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
ISO 7405:2008	Dentistry Evaluation of biocompatibility of medical devices used in dentistry
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
EN 50103 : 1995	GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY
ISO 1942-5:1989	Dental vocabulary Part 5: Terms associated with testing
EN 46002 : 1996	QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
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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CR 12401 : 1996

DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

Category

Subcategory