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About This Item
Full Description
Includes corrected version, October 2018.
ISO 10993-1:2018 specifies:
This document also gives guidelines for the assessment of biological hazards arising from:
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.
ISO 10993-1:2018 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.
- 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 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.
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.
Document History
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ISO 10993-1:2018
currently
viewing
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process- Most Recent
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ISO 10993-1:2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process- Historical Version
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ISO 10993-1:2003
Biological evaluation of medical devices - Part 1: Evaluation and testing- Historical Version