CAN/CSA-ISO 10993-5-01:2001

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

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标准号

CAN/CSA-ISO 10993-5-01:2001

发布

2001年

发布单位

SCC

当前最新

CAN/CSA-ISO 10993-5-01:2001

 

 

代替标准

MEDICAL EQUIPMENT, SURGICAL IMPLANTS, SURGICAL IMPLANTS, DENTAL EQUIPMENT,DENTAL MATERIALS, TESTS, BIOLOGICAL TESTS, DETERMINATION, CYTOTOXICITY,BIOASSAY, IN-VITRO

被代替标准

CAN/CSA-ISO 10993.5-97

适用范围

This National Standard of Canada is equivalent to International Standard ISO 10993-5:1999. 1 Scope This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or through diffusion a) with extracts of a device, and/or b) in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

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