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BS EN ISO 10993-1:2020 – TC

BS EN ISO 10993-1:2020 – TC

$246.62

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

Published By Publication Date Number of Pages
BSI 2020 110
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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
1 compares BS EN ISO 10993-1:2020
2 TRACKED CHANGES
Text example 1 — indicates added text (in green)
6 Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC on Medical devices
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this International Standard.
7 Table ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC on Active Implantable Medical Devices
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this International Standard.
9 Foreword
11 Introduction
17 3.2
material
3.3
final product
3.4
data set
22 5.1 General
23 5.2 Categorization by nature of body contact
5.2.1 Non-contacting medical devices
5.2.15.2.2 Surface-contacting medical devices
5.2.25.2.3 ExternalExternally communicating medical devices
24 5.2.35.2.4 Implant medical devices
5.3 Categorization by duration of contact
5.3.1 Contact duration categories
5.3.2 Transitory-contacting medical devices
25 5.3.3 Medical devices with multiple contact duration categories
6.1 Physical and chemical information for biological risk analysis
26 6.2.1 General
6.2.2 Test descriptions
6.2.2.1 General
6.2 Gap analysis and selection of biological endpoints for assessment
27 6.3 Biological testing
6.3.1 General
28 6.3.2 Testing for evaluation
The evaluation tests described in 6.2.2.2 to 6.2.2.15Testing for the evaluations specified in 6.3.2.1 to 6.3.2.15 shall be considered and carried out where necessary to complete the data sets needed for the biological evaluation of the particular medi…
6.2.2.3 Delayed-type hypersensitivity
30 6.2.2.9 Haemocompatibility
6.2.2.10 Chronic toxicity
31 6.2.2.11 Carcinogenicity
41 B.2.2.1 Intended use/device characteristics
B.2.2.2 Biological hazard identification
B.2.2.3 Exposure assessment
B.2.2.4 Risk estimation
42 B.2.2.5 Risk evaluation
B.2.2.6 Risk control
B.2.3 Overall residual risk/benefit evaluation
B.2.4 Biological evaluation report
B.2.5 Post-production information
B.3 Testing and test reports
43 B.4 Biological evaluation report
B.5 Conclusion
58 Bibliography
62 undefined
64 European foreword
Endorsement notice
66 Foreword
68 Introduction
69 1 Scope
2 Normative references
70 3 Terms and definitions
73 4 General principles applying to biological evaluation of medical devices
77 5 Categorization of medical devices
5.1 General
5.2 Categorization by nature of body contact
5.2.1 Non-contacting medical devices
78 5.2.2 Surface-contacting medical devices
5.2.3 Externally communicating medical devices
79 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
80 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
81 6.3 Biological testing
6.3.1 General
82 6.3.2 Testing for evaluation
86 7 Interpretation of biological evaluation data and overall biological risk assessment
88 Annex A (informative) Endpoints to be addressed in a biological risk assessment
93 Annex B (informative) Guidance on the conduct of biological evaluation within a risk management process
106 Annex C (informative) Suggested procedure for literature review
108 Bibliography

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BS EN ISO 10993-1:2020 - TC
$246.62