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BS EN ISO 10993-1:2020

BS EN ISO 10993-1:2020

$189.07

Biological evaluation of medical devices – Evaluation and testing within a risk management process

Published By Publication Date Number of Pages
BSI 2020 50
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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.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
6 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
13 4 General principles applying to biological evaluation of medical devices
17 5 Categorization of medical devices
5.1 General
5.2 Categorization by nature of body contact
5.2.1 Non-contacting medical devices
18 5.2.2 Surface-contacting medical devices
5.2.3 Externally communicating medical devices
19 5.2.4 Implant medical devices
5.3 Categorization by duration of contact
5.3.1 Contact duration categories
5.3.2 Transitory-contacting medical devices
5.3.3 Medical devices with multiple contact duration categories
20 6 Biological evaluation process
6.1 Physical and chemical information for biological risk analysis
6.2 Gap analysis and selection of biological endpoints for assessment
21 6.3 Biological testing
6.3.1 General
22 6.3.2 Testing for evaluation
26 7 Interpretation of biological evaluation data and overall biological risk assessment
28 Annex A (informative) Endpoints to be addressed in a biological risk assessment
33 Annex B (informative) Guidance on the conduct of biological evaluation within a risk management process
46 Annex C (informative) Suggested procedure for literature review
48 Bibliography

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BS EN ISO 10993-1:2020
$189.07