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  • BSI
    PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
    Edition: 2019
    $316.70
    / user per year

Description of PD ISO/TS 21726:2019 2019

This document describes the basis for, selection of, and general applicability of a threshold of toxicological concern (TTC) value for a constituent present in/on a medical device or released from a medical device. The TTC values in this document can be used for:

  • comparing to a maximum concentration of an identified or unidentified constituent in an extract (see ISO 10993‑18);

  • supporting toxicological equivalence;

  • comparing to a maximum exposure dose estimate of an identified constituent (see ISO 10993‑17).

NOTE Constituent is defined in 3.1.

ISO 10993‑18 specifies how to convert TTC (µg/d) into a concentration (µg/ml).

TTC is not applicable to constituents with adequate toxicity data for deriving a tolerable intake (TI) value (see ISO 10993‑17).

The TTC values established in this document are protective for carcinogens, systemic toxicants, and reproductive toxicants (see Clause 5). This document does not include TTC values for other biological endpoints assessed as part of the biological evaluation of a medical device, per ISO 10993‑1, for example:

  • cytotoxicity;

  • irritation;

  • sensitization;

  • hemocompatibility;

  • material mediated pyrogenicity;

  • local effects that occur in tissues at the site of contact between a medical device and the body (e.g. the observations from implantation studies).

The TTC values in this document do not apply to potential exposure via gas pathways of medical devices. For application of TTC for constituents present/released from these devices, see the ISO 18562 series.

The TTC values presented in this document are not applicable for the safety assessment of cohort of concern (see 5.3).



Standard NumberPD ISO/TS 21726:2019
TitleBiological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
StatusConfirmed
Publication Date2019-02-05
Identical National Standard OfISO/TS 21726:2019
DescriptorsCompatibility, Medical equipment, Electronic medical equipment, Electrical medical equipment, Evaluation
ICS11.100.20 Biological evaluation of medical devices
CommitteeCH/194
ISBN978 0 580 99738 9
PublisherBSI
Pages14

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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