BS EN ISO 13504:2012
Current
The latest, up-to-date edition.
Dentistry. General requirements for instruments and related accessories used in dental implant placement and treatment
Hardcopy , PDF
English
31-07-2012
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Intended performance
6 Performance attributes
7 Material selection
8 Performance evaluation
9 Manufacturing
10 Reprocessing
11 Information to be supplied by
the manufacturer
Annex A (normative) - Materials found acceptable
for instrument manufacture
Annex B (informative) - Cross-referencing of steel
grades specified in international,
regional or national standards
Bibliography
Defines 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.
| Committee |
CH/106
|
| DevelopmentNote |
Supersedes 11/30212235 DC. (07/2012) Reviewed and Confirmed by BSI, February 2018. (02/2018)
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| Standards | Relationship |
| ISO 13504:2012 | Identical |
| EN ISO 13504:2012 | Identical |
| 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 15883-1:2006 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 15882:2008 | Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
| ISO 15510:2014 | Stainless steels — Chemical composition |
| ISO 11737-2:2009 | Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ASTM A 959 : 2016 : REDLINE | Standard Guide for Specifying Harmonized Standard Grade Compositions for Wrought Stainless Steels |
| ISO 15730:2000 | Metallic and other inorganic coatings — Electropolishing as a means of smoothing and passivating stainless steel |
| ISO 5832-3:2016 | Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| 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 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants General requirements |
| ISO 1942:2009 | Dentistry Vocabulary |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 5832-2:1999 | Implants for surgery Metallic materials Part 2: Unalloyed titanium |
| ISO 7153-1:2016 | Surgical instruments Materials Part 1: Metals |
| 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 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 15883-2:2006 | Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. |
| ISO 1043-1:2011 | Plastics — Symbols and abbreviated terms — Part 1: Basic polymers and their special characteristics |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of 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 |
| SAC GB/T 20878 : 2007 | STAINLESS AND HEAT-RESISTING STEELS - DESIGNATION AND CHEMICAL COMPOSITION |
| EN 10088-1:2014 | Stainless steels - Part 1: List of stainless steels |
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