GB/T 41844-2022DNA检验用产品人源性污染防控规范.pdf

ICS13.310

CCSA92

中华人民共和国国家标准

GB/T41844-2022

DNA检验用产品人源性污染防控规范

SpecificationsforpreventionandcontrolofhumanDNA

contaminationinDNAtestingproducts

(ISO18385:2016,MinimizingtheriskofhumanDNAcontaminationinproducts

usedtocollect,storeandanalyzebiologicalmaterialforforensicpurposes-

Requirements.MOD)

2022-10-12发布2023-05-01实施

国家市场监督管理总局中＋

国家标准化管理委员会/.X.~IJ

GB/T41844-2022

目次

前言……………........................……..................………………·…...r

引言…………………………H

1范围………·

2规范性引用文件…·

3术语和l定义·

4缩’各i吾……………………3

5一般规定…········……··················……··嗣………………··················………….4

6产tfl.r类型…………………4

6.1总体要求…··咱………………·……4

6.2与生物斑迹直接接触或可能含有人源性DNA的产品…….4

6.3涉及人激性DNA分衍的化学品、试剂、溶剂等一次性槌材……5

6.4生物材料采集和分析过程中使用的防护性产品……...............……….5

7质量笆’理体系…··唱…….5

7.1总体要求········…··················……··嗣……………··················…………….5

7.2义件和记录…………………………5

7.3授权…………………6

7.4分包早日原料采购…·················……··················…………….6

7.5不合格产品的控甘~J………………·················……··················…………….6

7.6纠正和顽防拟施…··咱…….6

7.7丁合作人员污染检测规定…………··咱…….6

8人源性DNA污染风险管理……………7

8.1总体要求…··唱…·…7

8.2风险评估········………………··················………··嗣………………··················……