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Norm
ÖNORM EN ISO 10993-1
Issue date: 2011 03 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)
This part of ISO 10993 describes the general principles governing the biological evaluation of medical devices within a risk management
process; the general categorizati...
Withdrawn: 2021 04 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 33 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 10993 describes the general principles governing the biological evaluation of medical devices within a risk management
process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyse the biological safety of the medical device and the assessment of the biological safety of the medical device.
This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect
contact with the patient´s body, nor does it cover biological hazards arising from any mechanical failure. Other
parts of ISO 10993 cover specific tests, as indicated in the Foreword.
ÖNORM EN ISO 10993-1
2021 04 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management p...
Norm
ÖNORM EN ISO 10993-1
2011 03 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management p...
Norm
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ÖNORM EN ISO 10993-1
2010 03 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management p...
Norm
ÖNORM EN ISO 10993-1
2009 08 15
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
Norm
ÖNORM EN ISO 10993-1
2003 12 01
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
Norm
ÖNORM EN ISO 10993-1
1998 07 01
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997)
Norm
Norm
Issue date :
2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2003 10 22
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Norm
Issue date :
2002 10 22
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
Norm
Issue date :
2009 05 20
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
Norm
Issue date :
2007 04 04
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
Norm
Issue date :
2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Norm
Issue date :
2009 11 30
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
Norm
Issue date :
2010 07 27
Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
Norm
Issue date :
2006 08 15
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Norm
Issue date :
2007 10 31
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corrected version 2008-02)
Draft
Issue date :
2010 05 06
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Norm
Issue date :
2010 06 04
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Norm
Issue date :
2001 11 22
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
Norm
Issue date :
2000 11 30
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (Corrected version 2001-03)
Norm
Issue date :
2010 02 09
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
Norm
Issue date :
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
Issue date :
2005 06 30
Biological evaluation of medical devices — Part 18: Chemical characterization of materials
Technische Regel
Issue date :
2006 05 19
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
Technische Regel
Issue date :
2006 08 03
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
Norm
Issue date :
2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
Norm
Issue date :
2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2014 09 24
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Norm
Issue date :
2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Norm
Issue date :
2019 11 26
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
Norm
Issue date :
2017 09 14
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Norm
Issue date :
2010 06 04
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Norm
Issue date :
2001 11 22
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
Norm
Issue date :
2019 11 26
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
Norm
Issue date :
2017 05 16
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
Norm
Issue date :
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
Issue date :
2020 01 13
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
Technische Regel
Issue date :
2020 03 12
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
Technische Regel
Issue date :
2006 08 03
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
Norm
Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices
Norm
Issue date :
2021 04 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)