ISO 13504:2012
Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment

Standard No.

ISO 13504:2012

Release Date

2012

Published By

International Organization for Standardization (ISO)

Latest

ISO 13504:2012

Scope

This International Standard specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area. It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system. It is not applicable to the power-driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant. With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer.

ISO 13504:2012 Referenced Document

• ISO 1043-1:2011 Plastics - Symbols and abbreviated terms - Part 1: Basic polymers and their special characteristics
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• 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 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
• ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
• ISO 17665-1:2006 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 1942:2009 Dentistry - Vocabulary
• ISO 2768-1:1989 General tolerances; part 1: tolerances for linear and angular dimensions without individual tolerance indications
• ISO 5832-2:1999 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
• ISO 5832-3:1996 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
• ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

ISO 13504:2012 history

• 2012 ISO 13504:2012 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment