Overview

This part of ISO 10993 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. The process described in this document is not intended to apply to circumstances where the toxicological risk has been estimated by other means. The process described in this document is also not applicable to medical device constituents that do not contact the body. The principal changes compared to the previous edition include: a) the title has been amended; b) the Scope has been revised; c) different terms and definitions have been deleted, and new terms and definitions have been added; d) the subsequent clauses have been deleted: Clause 4, "General principles for establishing allowable limits", Clause 5, "Establishment of tolerable intake (TI) for specific leachable substances", Clause 6, "Calculation of tolerable exposure (TE)", Clause 7, "Feasibility evaluation", Clause 8, "Benefit evaluation", and Clause 9, "Allowable limits"; e) the subsequent new clauses have been added: Clause 4, "Abbreviated terms and symbols", Clause 5, "Toxicological risk assessment within the biological evaluation process", Clause 6, "Constituent specific toxicological information", Clause 7, "Tolerable contact level, tolerable intake and threshold of toxicological concern", Clause 8, "Exposure dose estimation", and Clause 9, "Margin of safety"; f) Annex A has been moved to Annex D; g) Annex B and Annex C have been deleted; h) new annexes have been added: Annex A (normative), "Evaluation of toxicological data quality when selecting a point of departure", Annex B (normative), "Derivation of toxicological screening limits", Annex C (normative), "Derivation of constituent TI or TCL for select endpoints", Annex E (normative), "Estimation of an exposure dose", and Annex F (informative), "Reporting of toxicological risk assessment information"; This standard differs from DIN EN ISO 10993-17:2009-08 as follows: a) the title has been amended; b) the Scope has been revised; c) different terms and definitions have been deleted, and new terms and definitions have been added; d) the subsequent clauses have been deleted: Clause 4, "General principles for establishing allowable limits", Clause 5, "Establishment of tolerable intake (TI) for specific leachable substances", Clause 6, "Calculation of tolerable exposure (TE)", Clause 7, "Feasibility evaluation", Clause 8, "Benefit evaluation", and Clause 9, "Allowable limits"; e) the subsequent new clauses have been added: Clause 4, "Abbreviated terms and symbols", Clause 5, "Toxicological risk assessment within the biological evaluation process", Clause 6, "Constituent specific toxicological information", Clause 7, "Tolerable contact level, tolerable intake and threshold of toxicological concern", Clause 8, "Exposure dose estimation", and Clause 9, "Margin of safety"; f) Annex A has been moved to Annex D; g) Annex B and Annex C have been deleted; h) new annexes have been added: Annex A (normative), "Evaluation of toxicological data quality when selecting a point of departure", Annex B (normative), "Derivation of toxicological screening limits", Annex C (normative), "Derivation of constituent TI or TCL for select endpoints", Annex E (normative), "Estimation of an exposure dose", and Annex F (informative), "Reporting of toxicological risk assessment information"; i) a new Annex ZA on the relationship between this European Standard and the essential safety and performance requirements of Regulation (EU) 2017/745 aimed to be covered has been added. This document has been prepared by ISO/TC 194 "Biological and clinical evaluation of medical devices" in collaboration with Technical Committee CEN/TC 206 "Biological and clinical evaluation of medical devices", the secretariat of which is held by DIN (Germany). The responsible German committee is Working Committee NA 027-07-12 AA "Biologische Beurteilung von Medizinprodukten" "Biological evaluation of medical devices" at DIN Standards Committee Optics and Precision Mechanics (NAFuO).

Document: references other documents

Responsible national committee

NA 027-07-12 AA - Biological evaluation of medical devices  

Responsible european committee

CEN/TC 206 - Biological and clinical evaluation of medical devices  

Responsible international committee

ISO/TC 194/WG 11 - Allowable limits for leachable substances