I.S. 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
01-01-2011
Publisher
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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 |
CEN/TC 55
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| UNI EN 1642 : 2012 | Identical |
| DIN EN 1642:2012-06 | Identical |
| BS EN 1642:2011 | 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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