VDI 5703:2015-09
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
German - English
01-09-2015
04-05-2023
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
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| Pages |
0
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| PublisherName |
Verlag des Vereins Deutscher Ingenieure
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| Status |
Superseded
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| 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 |
| 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 |
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