Каталог стандартов

+7 (495) 223-46-76 +7 (812) 309-78-59
inform@normdocs.ru

ÖNORM EN ISO 9363-1:2000-02

Действует
Optics and optical instruments - Contact lenses - Determination of cytotoxicity of contact lens material - Part 1: Agar overlay test and growth inhibition test (ISO 9363-1:1994)
This part of ISO 9363 specifies two in vitro methods for determining the cytotoxicity of contact lens materials: the agar overlay test; and the growth inhibition test. The primary purpose of these tests is to reveal the presence of leachable cytotoxic substances in or on contact lenses.
NOTES
1 Attention is drawn to ISO 10993-5.
2 A minimum of one in vitro test is recommended for preclinical evaluation of new types of contact lenses. Either one of the following two in v;tro tests may be used for the in vitro requirement.
Diese ÖNORM legt zwei In-vitro-Verfahren zur Bestimmung der Zytotoxizität von Kontaktlinsenmaterialien fest: die Agar-Überschichtungs-Prüfung und die Wachstumsinhibitions-Prüfung. Der Zweck dieser Prüfungen ist der Nachweis von auslaugbaren zytotoxischen Substanzen in oder auf Kontaktlinsen.
ICS
11.040.70 Ophthalmic. Including ophthalmic implants, glasses, contact lenses and their cleaning products / Офтальмологическое оборудование