11/30212235 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 13504 - DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
Hardcopy , PDF
English
31-07-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Intended performance
6 Design attributes
7 Selection of materials
8 Design 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
BS EN ISO 13504
| Committee |
CH/106/4
|
| DocumentType |
Draft
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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 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 |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of 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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