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PD CR 12401:2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Dentistry. Guidance on the classification of dental devices and accessories
Available format(s)

Hardcopy , PDF

Superseded date

30-06-2009

Language(s)

English

Published date

14-08-2003

Publisher

British Standards Institution

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
CH/106
DevelopmentNote
Supersedes BS PD6618(1997). (02/2005)
DocumentType
Standard
Pages
14
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
CEN/TR 12401:2009 Identical
CR 12401 : 1996 Identical

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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Hardcopy - English
PDF - English
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