金币
UID423349
帖子
主题
积分4
注册时间2019-2-2
最后登录1970-1-1
听众
性别保密
|
发表于 2019-2-2 16:37:15
|
显示全部楼层
The main changes compared to the previous edition are as follows:
a) revised Annex A “Endpoints to be addressed in a biological risk assessment” with new columns for
“physical and/or chemical information” and “material mediated pyrogenicity” as well as columns
for “chronic toxicity,” “carcinogenicity,” “reproductive/developmental toxicity,” and “degradation”
which now indicates “endpoints” to be considered with “E” (instead of “tests” to be conducted with
an “X”);
b) replaced Annex B “Guidance on the risk management process” with “Guidance on the conduct of
biological evaluation within a risk management process” (formerly ISO TR 15499);
c) additional definitions for terms used throughout the ISO 10993 series of standards;
d) additional information on the evaluation of “Non-contacting medical devices” and new information
on the evaluation of “Transitory-contacting medical devices”;
e) additional information on the evaluation of nanomaterials, and absorbable materials;
f) additional reference to ISO 18562 (all parts) for “Biocompatibility evaluation of breathing gas
pathways in healthcare applications”;
g) significant editing changes throughout the document;
A list of all parts in the ISO 10993 series can be found on the ISO website |
|
[复制链接]
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
置顶卡
变色卡
楼主
