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  • DIN EN ISO 13504:2012-10

    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

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN HDBK 267/2.

    General Product Information - (Show below) - (Hide below)

    Committee TC 106
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    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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