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BS EN 1642:2011

Current

Current

The latest, up-to-date edition.

Dentistry. Medical devices for dentistry. Dental implants

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-10-2011

€165.94
Excluding VAT

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC
Bibliography

Describes general requirements for dental implants and accessories.

Committee
CH/106
DevelopmentNote
Supersedes 94/508362 DC. (06/2004) Supersedes 08/30184615 DC. (12/2009)
DocumentType
Standard
Pages
16
PublisherName
British Standards Institution
Status
Current
Supersedes

This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.

Standards Relationship
I.S. EN 1642:2011 Identical
UNI EN 1642 : 2012 Identical
DIN EN 1642:2012-06 Identical
NS EN 1642 : 2011 Identical
UNE-EN 1642:2012 Identical
NEN EN 1642 : 2011 Identical
NBN EN 1642 : 2011 Identical
SN EN 1642 : 2012 Identical
NF EN 1642 : 2013 Identical
EN 1642:2011 Identical

EN ISO 14801:2016 Dentistry - Implants - Dynamic loading test for endosseous dental implants (ISO 14801:2016)
ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN 21942-1 : 1991 DENTAL VOCABULARY - GENERAL AND CLINICAL TERMS
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
EN 21942-2 : 1992 DENTAL VOCABULARY - DENTAL MATERIALS
EN ISO 22803:2005 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
ISO 1942-1:1989 Dental vocabulary Part 1: General and clinical terms
EN ISO 22794:2009 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
ISO 1942-2:1989 Dental vocabulary Part 2: Dental materials
ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
ISO 10451:2010 Dentistry — Contents of technical file for dental implant systems
EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
CEN/TR 12401:2009 Dentistry - Guidance on the classification of dental devices and accessories
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 3950:2016 Dentistry — Designation system for teeth and areas of the oral cavity
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
ISO 22794:2007 Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 1942-5:1989 Dental vocabulary Part 5: Terms associated with testing
EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 14801:2016 Dentistry Implants Dynamic loading test for endosseous dental implants
EN ISO 3950:2016 Dentistry - Designation system for teeth and areas of the oral cavity (ISO 3950:2016)
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 22803:2004 Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file
EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
EN 980:2008 Symbols for use in the labelling of medical devices
EN ISO 10451:2010 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)

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