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Norm

ÖNORM EN ISO 10993-1

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)

This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization ...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 55 Pages
Language:
German | English | Download GER/ENG
Optionally co-design standards:
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical 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; — the assessment of the biological safety of the medical device. This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient's body during intended use; — the user’s body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. This document also gives guidelines for the assessment of biological hazards arising from: — risks, such as changes to the medical device over time, as a part of the overall biological safety assessment; — breakage of a medical device or medical device component which exposes body tissue to new or novel materials. Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Devicespecific or product standards address mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.
ÖNORM EN ISO 10993-1
2021 04 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management p...
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ÖNORM EN ISO 10993-1
2011 03 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management p...
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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...
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ÖNORM EN ISO 10993-1
2009 08 15
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
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ÖNORM EN ISO 10993-1
2003 12 01
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
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ÖNORM EN ISO 10993-1
1998 07 01
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997)
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ISO 10993-2:2006
Issue date : 2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
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ISO 10993-3:2014
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ISO 10993-7:2008
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Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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ISO 10993-9:2019
Issue date : 2019 11 26
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
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ISO 10993-11:2017
Issue date : 2017 09 14
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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ISO 10993-13:2010
Issue date : 2010 06 04
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
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ISO 10993-14:2001
Issue date : 2001 11 22
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
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ISO 10993-15:2019
Issue date : 2019 11 26
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
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ISO 10993-16:2017
Issue date : 2017 05 16
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
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ISO 10993-17:2002
Issue date : 2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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ISO 10993-18:2020
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
ISO/TS 10993-20:2006
Issue date : 2006 08 03
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
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ISO 14971:2007
Issue date : 2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
Norm
ISO 10993-1:2018
Issue date : 2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)