CAN/CSA-ISO 10993.7-1998(R2007)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

CAN/CSA-ISO 10993.7-1998(R2007) 发布历史

CAN/CSA-ISO 10993.7-1998(R2007)由SCC 发布于 1998-01-31。

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CAN/CSA-ISO 10993.7-1998(R2007) 的最新版本是哪一版？

最新版本是 CAN/CSA-ISO 10993.7-1998(R2007) 。

CAN/CSA-ISO 10993.7-1998(R2007)的历代版本如下：

• 0000年 CAN/CSA-ISO 10993.7-1998(R2007)

This National Standard of Canada is equivalent to International Standard ISO 10993-7:1995. 1 Scope This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background and guidance also is included in informative annexes. EO-sterilized devices that have no patient contact (e.g. in vitro diagnostic devices) are not covered by this International Standard.

标准号

CAN/CSA-ISO 10993.7-1998(R2007)

发布

1998年

发布单位

SCC

当前最新

CAN/CSA-ISO 10993.7-1998(R2007)

 

 

代替标准

MEDICAL EQUIPMENT, ETHYLENE OXIDE, STERILIZATION, TESTS, BIOLOGICAL TESTS,BIOASSAY, DETERMINATION, CHEMICAL RESIDUES.

被代替标准

2007-12-21

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