GB/T 8600-1988
Replaced
GB 27955-2020
Active
National standards
force_standard
GB 27955-2020 Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer
GB 27955-2020 Hygienic requirements for low-temperature hydrogen peroxide gas plasma sterilizer
Basic Information
Standard Code:
GB 27955-2020
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
yes
CCS Name:
Health
ICS Name:
Disinfection and sterilization
Publish Date:
2020-04-09
Implement Date:
2020-11-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
中华人民共和国国家卫生健康委员会
Pages:
13 pages
Scope
本标准规定了过氧化氢气体等离子体低温灭菌器的技术要求、应用范围、使用注意事项、检验规则、检验方法、标志与包装、运输和贮存。
本标准适用于不耐湿、不耐高温的医疗器械、器具和物品灭菌的过氧化氢气体等离子体低温灭菌器。
Development Information
Drafting Units:
中国疾病预防控制中心环境与健康相关产品安全所、北京协和医院、北京大学口腔医院、河北省卫健委综合监督执法服务中心、山东省卫生健康委员会执法监察局、湖北省人民医院、青岛大学附属医院、山东省立医院、江西省卫生监督所、浙江省疾病预防控制中心、浙江大学医学院附属邵逸夫医院
Drafting Persons:
张流波、张剑、张青、李炎、刘翠梅、王海森、袁青春、徐亚青、吕亚青、高辉、周玉、胡国庆、王亚娟、张海军、李亚东、邹辰明、刘霞、王娟、吴伟
Replace the following standards
Referenced Standards
GB 19192-2003 Hygienic requirement for contact lens care solution
GBZ 159
GBZ/T 300.48
消毒技术规范(2002年版)[卫生部(卫法监发〔2002〕282号)]
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB 1616-2003 Hydrogen peroxide for industrial use
GB/T 1616-2014 Hydrogen peroxide for industrial use
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity
GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization
GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
Related Standards
GB 8599-1988
Replaced
GB 8599-1988 Specifications for automated autoclave sterilizer
GB 15981-1995
Replaced
GB 15981-1995 Evaluating method and standard for the efficacy of disinfection and sterilization
GB 15982-1995
Replaced
GB 15982-1995 Hygienic standard for disinfection in hospitals
GB 16383-1996
Replaced
GB 16383-1996 Quality control standards for radiation sterilization of medical and hygienical products
GB 18279-2000
Replaced