医疗器械微生物试验操作规程

前言

为满足本公司产品的生物性能检测特制定本规程。

本检验规程是依据GB14233.2、GB15980、2015版《中国药典》等标准汇编而成，同时引用本公司相关操作规程。

本规程适用于本公司所有产品的微生物性能检测。

本规程由天台县康生医疗器械有限公司质管科编制。

本规程主要起草人：陈春雪

本规程审核人：干涛涛

本规程批准人：周婷

本规程实施日期： 2016 年2月14日

1.微生物实验室注意事项····································· ·····KS/CZ8.2.4-01-01

2.菌落形态、培养方法、存储方法····································KS/CZ8.2.4-01-02

3.菌种传代、接种、销毁············································KS/CZ8.2.4-01-03

4.培养基的制备、灭菌及储存········································KS/CZ8.2.4-01-04

5.产品无菌检查····················································KS/CZ8.2.4-01-05

6.指示灭菌效果检查················································KS/CZ8.2.4-01-06

7.产品初始污染菌检查··············································KS/CZ8.2.4-01-07

8.物体表面菌检查··················································KS/CZ8.2.4-01-08

9.人员手细菌检查··················································KS/CZ8.2.4-01-09