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.
EN 1642:2011 Referenced Document
EN 1041 Information supplied by the manufacturer of medical devices
EN 21942-1:1991 Dental Vocabulary - Part 1: General and Clinical Terms
EN 21942-2:1992 Dental Vocabulary - Part 2: Dental Materials
EN 556-1 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
EN ISO 10451 Dentistry - Contents of technical file for dental implant systems
EN ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
EN ISO 11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
EN ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/DAM 1:2022)
EN ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022)
EN ISO 14155-1 Clinical investigation of medical devices for human subjects - Part 1: General requirements
EN ISO 14155-2 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
EN ISO 14801 Dentistry - Implants - Dynamic loading test for endosseous dental implants
EN ISO 14971 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
EN ISO 1942-5:1994 Dental Vocabulary - Part 5: Terms Associated with Testing (ISO 1942-5:1989)
EN ISO 22794 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
EN ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
EN 1642:2011 history
2011EN 1642:2011 Dentistry - Medical devices for dentistry - Dental implants
2009EN 1642:2009 Dentistry - Medical devices for dentistry - Dental implants
2004EN 1642:2004 Dentistry - Medical devices for dentistry - Dental implants
1996EN 1642:1996 Dentistry - Medical Devices for Dentistry - Dental Implants