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VDI 5703:2015-09

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Superseded date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

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

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

DocumentType
Standard
Pages
0
PublisherName
Verlag des Vereins Deutscher Ingenieure
Status
Superseded
SupersededBy
Supersedes

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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