YY/T 1815-2022: Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

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Scope

This document specifies the method that uses threshold of toxicological concern (TTC)
to assess the biocompatibility of constituents of a medical device.
This document applies to.
- Compare with the maximum concentration of identified or unidentified
constituents in an extract (see GB/T 16886.18);
- Toxicological equivalence studies;
- Comparison with the estimated maximum exposure dose for an identified
constituent (see GB/T 16886.17).
This document does not apply to.
- Obtainment of tolerable intake (TI) values for components with sufficient toxicity
data (see GB/T 16886.17);
- Safety assessment of biological endpoints other than carcinogenicity, systemic
toxicity and reproductive toxicity in the biological evaluation of medical devices
in accordance with GB/T 16886.1, such as. cytotoxicity, irritation, sensitization,
hemocompatibility, material-mediated pyrogenicity, and local reactions to tissues
at the site of contact between a medical device and the human body (for example,
observations from implantation studies);
- Safety assessment of medical devices that have indirect contact with the human
body through the airway;
NOTE. For the application of TTC of constituents present or released in such devices, see the
ISO 18562 series of standards.
- Safety assessment with special concern constituents (cohort of concern constituent,
Coc) (see 5.3).

Basic Data

Standard ID	YY/T 1815-2022 (YY/T1815-2022)
Description (Translated English)	Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Word Count Estimation	10,192
Issuing agency(ies)	State Drug Administration