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  • BSI
    BS EN ISO 10993-1:2020 - TC Tracked Changes. Biological evaluation of medical devices - Evaluation and testing within a risk management process
    Edition: 2020
    $617.54
    / user per year

Description of BS EN ISO 10993-1:2020 - TC 2020

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. Device-specific or product standards address mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.

Standard NumberBS EN ISO 10993-1:2020 - TC
TitleTracked Changes. Biological evaluation of medical devices - Evaluation and testing within a risk management process
StatusRevision Underway
Publication Date2020-12-21
DescriptorsDental equipment, Clinical investigation instruments, Medical instruments, Biological hazards, Dental materials, Biological analysis and testing, Implants (surgical), Bioassay, Medical equipment, Contaminants, Cytotoxicity tests, Compatibility, Medical technology
ICS11.100.20 Biological evaluation of medical devices
CommitteeCH/194
ISBN978 0 539 16453 4
PublisherBSI
Pages110

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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