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  • VDI 5703:2015-09

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Systematical development for a model-based testing of medical devices

    Available format(s):  Hardcopy, PDF

    Superseded date:  04-05-2023

    Language(s):  German - English

    Published date:  01-09-2015

    Publisher:  Verlag des Vereins Deutscher Ingenieure

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

    Preliminary note
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Abbreviations
    5 Methodical approach
    6 Exemplary application
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines a methodical approach for the selection, the determination and, if applicable, the necessary development of test strategies for medical devices.

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

    Document Type Standard
    Publisher Verlag des Vereins Deutscher Ingenieure
    Status Superseded
    Superseded By
    Supersedes

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

    EN ISO 22523 : 2006 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006)
    VDI 2221:1993-05 Systematic approach to the development and design of technical systems and products
    EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    EN ISO 22675:2016 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
    ISO 22523:2006 External limb prostheses and external orthoses — Requirements and test methods
    EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
    VDI 3880:2011-10 Olfactometry - Static sampling
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    DIN EN ISO 22675:2016-12 PROSTHETICS - TESTING OF ANKLE-FOOT DEVICES AND FOOT UNITS - REQUIREMENTS AND TEST METHODS (ISO 22675:2016)
    EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    DIN EN ISO 22523:2007-04 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
    EN 15259:2007 Air quality - Measurement of stationary source emissions - Requirements for measurement sections and sites and for the measurement objective, plan and report
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    VDI 1000:2017-02 VDI Standardisation Work - Principles and procedures
    DIN EN ISO 10993-5:2009-10 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    DIN EN ISO 10993-12:2012-10 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    DIN EN ISO 10993-18:2009-08 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009
    ISO 10110-1:2006 Optics and photonics Preparation of drawings for optical elements and systems Part 1: General
    DIN EN ISO 14155:2012-01 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
    EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    DIN EN ISO 10993-10:2014-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    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
    VDI 2066 Blatt 1:1975-10 Particulate matter measurement; measuring of particulate matter in flowing gases; gravimetric determination of dust load; fundamentals
    ISO 22675:2016 Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods
    DIN EN 15259:2008-01 Air quality - Measurement of stationary source emissions - Requirements for measurement sections and sites and for the measurement objective, plan and report
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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