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UNI EN 1642 : 2012
Current
The latest, up-to-date edition.
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DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
09-02-2012
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 |
CT 44
|
DocumentType |
Standard
|
PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
Status |
Current
|
Supersedes |
Standards | Relationship |
I.S. EN 1642:2011 | Identical |
DIN EN 1642:2012-06 | Identical |
BS EN 1642:2011 | Identical |
SN EN 1642 : 2012 | Identical |
NF EN 1642 : 2013 | Identical |
EN 1642:2011 | Identical |
NS EN 1642 : 2011 | Identical |
UNE-EN 1642:2012 | Identical |
NEN EN 1642 : 2011 | Identical |
NBN 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 |
EN ISO 7405:2008/A1:2013 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
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) |
EN ISO 10993-1:2009/AC:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010) |
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