Standard No.:	GB 18278-2000
English Name:	Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
Chinese Name:	医疗保健产品灭菌 确认和常规控制要求 工业湿热灭菌
Chinese Classification:	C47    Public medical equipment
Professional Classification:	GB    National Standard
ICS Classification:	11.080.01 11.080.01    Sterilization and disinfection in general 11.080.01
Source Content Issued by:	CBTS
Issued on:	2000-1-2
Implemented on:	2001-5-1
Status:	superseded
Superseded by:	GB 18278.1-2015 Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
Superseded on:	2017-1-1
Abolished on:	2017-01-01
Target Language:	English
File Format:	PDF
Word Count:	10000 words
Translation Price(USD):	300.0
Delivery:	via email in 1~3 business day

本标准规定了湿热灭菌工艺的设定、确认及常规灭菌的监控要求。本标准涉及所有应用的湿热灭菌工艺，包括饱和蒸汽及空气-蒸汽混合气体，适用于所有工业生产厂和从事湿热灭菌工作者。虽然本标准未将非工业医疗保健部门的湿热灭菌明确地包括在内，但所列出的原则对其湿热灭菌大部分亦是有用的。