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BS EN ISO 10993-17:2023

BS EN ISO 10993-17:2023

$215.11

Biological evaluation of medical devices – Toxicological risk assessment of medical device constituents

Published By Publication Date Number of Pages
BSI 2023 80
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This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1. The process described in this document applies to chemical characterization information obtained in line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable. The process described in this document is not intended to apply to circumstances where the toxicological risk has been estimated by other means, such as: —    constituents, excluding cohort of concern or excluded chemicals, that are present in or extracted from a medical device at an amount representative of patient exposure below a relevant, toxicologically-based reporting threshold (see applicable requirements in ISO 10993-18:2020, Annex E and ISO/TS 21726); —    a new or changed medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device (see applicable requirements in ISO 10993-18:2020, Annex C). The process described in this document is also not applicable to: —    medical device constituents that do not contact the body (e.g. in vitro diagnostics); —    biological risks associated with physical interactions of the medical device with the body (i.e. application of mechanical forces, energy or surface morphology, etc.), provided that the chemical exposure is not changed; —    active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations can apply; —    exposure to a particular constituent that arises from sources other than the device, such as food, water or air.

PDF Catalog

PDF Pages PDF Title
2 undefined
8 Annex ZA (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
12 Foreword
14 Introduction
15 1 Scope
2 Normative references
16 3 Terms and definitions
21 4 Abbreviated terms and symbols
23 5 Toxicological risk assessment within the biological evaluation process
5.1 General
5.1.1 Risk assessment principles
5.1.2 Hazard identification
24 5.1.3 Risk estimation
26 5.2 Toxicological risk assessment process
28 6 Constituent specific toxicological information
6.1 General
6.2 Identification of hazardous constituents
6.2.1 General
30 6.2.2 Application of the toxicological screening limit
31 6.2.3 Identification of human carcinogens or suspected human carcinogens
6.2.4 Selection of the point of departure
32 7 Tolerable contact level, tolerable intake and threshold of toxicological concern
7.1 Derivation of TCL and TI
7.2 Application of TTC
33 8 Exposure dose estimation
34 9 Margin of safety
9.1 General
9.2 Calculating the margin of safety
9.2.1 General
36 9.2.2 Combining MoS values to address additivity of harm
37 10 Toxicological risk acceptance criteria
10.1 General
10.2 Further risk analysis or risk evaluation or risk control
38 11 Reporting requirements
39 Annex A (normative) Evaluation of toxicological data quality when selecting a point of departure
40 Annex B (normative) Derivation of toxicological screening limits
47 Annex C (normative) Derivation of constituent TI or TCL for select endpoints
55 Annex D (informative) Typical assumptions for biological parameters
58 Annex E (normative) Estimation of an exposure dose
67 Annex F (informative) Reporting of toxicological risk assessment information
72 Bibliography

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BS EN ISO 10993-17:2023
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