【CODEX翻译】GB 38598-2020 消毒产品标签说明书通用要求-英文版PDF
【CODEX】GB 38598-2020 消毒产品标签说明书通用要求-英文版PDF
GB 38598-2020 消毒产品标签说明书通用要求
General Requirement for Label and Instruction Book of Disinfection Products
1 范围
1 Scope
本标准规定了消毒剂、消毒器械、指示物、卫生用品的标签、说明书通用要求和各项指标标注要求。
This Standard specifies the general requirements for labels and instruction books of disinfectants, disinfection apparatuses, indicators and sanitary products, and the requirements for the marking of various indicators.
本标准适用于中华人民共和国境内生产、销售和使用的消毒产品。
This Standard is applicable to disinfection products produced, sold and used within the territory of the People’s Republic of China.
本标准不适用于不在国内销售和使用的出口消毒产品。
This Standard is not applicable to exported disinfection products not sold or used in the country.
2 规范性引用文件
2 Normative References
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文 件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB 190 危险货物包装标志
GB 190 Packing Symbol of Dangerous Goods
GB/T 191 包装储运图示标志
GB/T 191 Packaging-Pictorial Marking for Handling of Goods
GB 15979 —次性使用卫生用品卫生标准
GB 15979 Hygienic Standard for Disposable Sanitary Products
消毒技术规范(2002年版)(中华人民共和国卫生部)
Technical Standard for Disinfection (Version 2002) (National Health Commission of the People’s Republic of China)
健康相关产品命名规定(卫法监发〔2001〕109号)
Regulations on Naming Health-related Products (supervised and issued by National Health Commission of the People’s Republic of China [2001] No. 109)
定量包装商品计量监督管理办法(国家质量监督检验检疫总局令〔2005〕第75号)
Measures for the Supervision and Management of Quantitative Packaging Commodities (Decree of the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China [2005] No. 75)
危险化学品目录(国家安全生产监督管理总局第10部门公告2015年第5号)
List of Hazardous Chemicals (State Administration of Work Safety, No. 10 Department Announcement, Year 2015, No. 5)
3 Terms and Definitions
下列术语和定义适用于本文件。
The following terms and definitions are applicable to this document.
3.1 消毒产品
disinfection products
纳人消毒产品生产类别分类目录的消毒剂、消毒器械、指示物和卫生用品等与人体健康相关的产品。
Disinfectants products refer to products related to human health and included in the classification catalog of disinfection product production categories, such as: disinfectants, disinfection apparatuses, indicators and sanitary products, etc.
注1: 指示物包括生物指示物、化学指示物和灭菌物品包装物。
注2: 卫生用品包括抗菌制剂、抑菌制剂、隐形眼镜护理用品(含隐形眼镜护理液、隐形眼镜保存液、隐形眼镜清洁剂)、湿巾、卫生湿巾和其他卫生用品。
NOTE 1: the indicators include biological indicators, chemical indicators and sterilization packaging materials.
NOTE 2: The sanitary products include antibacterial agents, bacteriostats, contact lens care products (including contact lens care solution, contact lens preservation solution and contact lens cleaning solution), wet wipes, hygiene wet wipes and other sanitary products.
3.2 新消毒产品
new disinfection products
利用新材料、新工艺技术和新杀菌原理生产的消毒剂和消毒器械。
New disinfection products refer to disinfectants and disinfection apparatuses produced with new materials, new processes and technology, and new sterilization principles.
3.3 消毒剂
disinfectant
用于杀灭传播媒介上的微生物使其达到消毒或灭菌要求的制剂。
Disinfectant refers to an agent used to kill microorganisms on the media to achieve disinfection or sterilization requirements.
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