UNI 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
15-11-2012
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
Describes general requirements for instruments and related accessories to be used specifically in dental implantology in the craniofacial area.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Standards | Relationship |
| ISO 13504:2012 | Identical |
| EN ISO 13504:2012 | Identical |
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| 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 |
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| 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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