EN ISO 13504:2012 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012)
This International Standard specifies general requirements for the manufacture of instruments and relatedaccessories used in the placement of dental implants and further manipulations of connecting parts in thecraniofacial area.
EN ISO 13504:2012 Referenced Document
ISO 1043-1 Plastics — Symbols and abbreviated terms — Part 1: Basic polymers and their special characteristics AMENDMENT 1: New symbol ST for syndiotactic
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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 14155 Clinical investigation of medical devices for human subjects - Good clinical practice*， 2020-09-01 Update
ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 17664 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices*， 2017-09-30 Update
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 2768-1 General tolerances; part 1: tolerances for linear and angular dimensions without individual tolerance indications
ISO 5832-2 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium*， 2018-03-01 Update
ISO 5832-3 Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy*， 2021-11-18 Update
ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry*， 2018-10-01 Update
EN ISO 13504:2012 history
2012EN ISO 13504:2012 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012)