Standard Practice for Selecting Biological Test Methods for Materials and Devices

Importancia y uso:

4.1 The objective of this practice is to provide information to consider when selecting and conducting biological testing, when deemed necessary.

4.2 A matrix listing the biological endpoints relevant to a biocompatibility evaluation of materials, medical devices, and their applications is included in Table 1. The expected nature of tissue contact and duration of use of a medical device is also included. The position of row and column intersection is marked to indicate the types of biological tests that should be considered for a material or medical device for the specific application, when testing is warranted.

(A) Subacute/subchronic toxicity assessment should reflect duration of worst-case clinical use.(B) Devices contacting cerebral spinal fluid (CSF) should be evaluated for indirect hemolysis because CSF is reabsorbed into the venous system.(C) See 6.6.1.(D) See 6.13.(E) In applicable situations, consider that a degradation evaluation should be provided for any medical devices, medical device components, or materials remaining in contact with tissue that are intended to break down as a result of chemical and/or biologic reactions. See 5.1.5.(F) See 6.14 for additional information.(G) “E” means endpoints recommended to be evaluated based on the nature and duration of tissue contact.(H) Tissue includes tissue fluids and subcutaneous spaces.(I) For all devices used in extracorporeal circuits.

Subcomité:

F04.16

Referida por:

F2901-19, F1781-21, F2847-17, F2064-17, F0086-21, D8389-21, F0881-94R22, F0755-19, F1855-00R19, F2887-23, F2739-19, F1538-24, F2665-21, F1439-24, F0619-20, F2042-18, F0702-18, F1357-23, F2565-21, F0624-09R24, F0639-09R24, F2097-23, F2051-00R22, F0623-19, F0451-21, F0763-22, F0641-09R23, F3510-21, F2820-24, F1378-18E01, F2066-23, F2808-23, F2229-21, F1903-18, F1828-22, F0997-18, F0750-20, F1813-21, F2313-24, F0648-21, F1185-23, F0756-17, F2902-24, F3087-15R24, F0703-18R22, F2026-23, F2581-25, F2103-18, F3333-20, F3274-21, F2347-24, F1441-03R22, F1713-08R21E01, F3384-21, E2524-22, F2148-18, F0895-25, F2695-12R20, F1088-23, F0749-20, F2315-18, F1984-99R18, F2097-23, F0813-20, F0665-09R24, F2759-19, F2384-24, F1581-08R25, F2150-19, E3219-20, F3089-23, F1925-24, F1635-24, F2212-20, F1904-23, F2579-24, F3659-24

Volúmen:

13.01

Número ICS:

07.080 (Biology. Botany. Zoology)

Palabras clave:

animal testing; biocompatibility; biocompatible; in vitro testing; in vivo testing; laboratory testing; toxicity;