DIN EN ISO 13504:2012-10
Current
Current
The latest, up-to-date edition.
DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
01-10-2012
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National foreword
National Annex NA (informative) - Bibliography
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
This standard is included in DIN HDBK 267/2.
| Committee |
TC 106
|
| DocumentType |
Standard
|
| Pages |
23
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Standards | Relationship |
| ISO 13504:2012 | Identical |
| EN ISO 13504:2012 | Identical |
| DIN HDBK 267/2 : 2ED 2014 | |
| DIN EN ISO 17937:2016-01 | Dentistry - Osteotome (ISO 17937:2015) |
| DIN EN ISO 19490:2016-07 (Draft) | DENTISTRY - SINUS MEMBRANE ELEVATOR (ISO 19490:2017) |
| 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 |
| DIN EN ISO 15223-1:2015-08 (Draft) | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03) |
| 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 |
| DIN EN ISO 17664:2016-06 (Draft) | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017) |
| 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 |
| DIN EN ISO 1043-1:2016-09 | PLASTICS - SYMBOLS AND ABBREVIATED TERMS - PART 1: BASIC POLYMERS AND THEIR SPECIAL CHARACTERISTICS (ISO 1043-1:2011 + AMD.1:2016) |
| DIN EN ISO 11137-1:2015-11 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| 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 |
| DIN EN ISO 17665-1:2006-11 | 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 17665-1:2006) |
| DIN EN ISO 5832-3:2015-06 (Draft) | IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 3: WROUGHT TITANIUM 6-ALUMINIUM 4-VANADIUM ALLOY (ISO 5832-3:2016) |
| 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 |
| DIN EN ISO 11135-1:2007-08 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 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 |
| DIN EN ISO 14155:2012-01 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011) |
| ISO 7153-1:2016 | Surgical instruments Materials Part 1: Metals |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| DIN EN ISO 7405:2013-12 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013) |
| DIN EN ISO 1942:2011-03 | Dentistry - Vocabulary (ISO 1942:2009, Corrected version 2010-03-01) |
| 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 |
| DIN EN ISO 5832-2:2012-08 | IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 2: UNALLOYED TITANIUM (ISO 5832-2:1999) |
| 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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