液体化学灭菌剂是一种经过验证的化学溶液，能够提供足够的微生物杀灭效果以获得FDA对灭菌标签声明的批准。其定义是：具有足够杀菌活性的液体化学实体或组合，能在特定条件下实现无菌状态，通过化学性质破坏微生物结构以实现灭菌。
| 标准号 & 类别 | 标准名称 | 发布 |
|---|---|---|
| AAMI ST58-2018 规范 |
Application of chemical sterilization and high-level disinfection in medical institutions
|
2018 美国医疗器械促进协会 |
| AAMI ST58:2024 指南标准 |
Chemical sterilization and high-level disinfection in health care facilities
|
2024-10-16 美国医疗器械促进协会 |
| AAMI TIR67-2018 指南标准 |
Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
职业安全 |
2018-02-23 美国医疗器械促进协会 |
| ANSI/AAMI ST58-2013(2018) 指南标准 |
Application of chemical sterilization and high-level disinfection in medical institutions
|
2018-09-09 美国国家标准学会 |
| ANSI/AAMI/ISO 14160:2011(2016) 规范标准 |
医疗保健产品的灭菌 使用动物组织及其衍生物的一次性医疗器械的液体化学灭菌剂 医疗器械灭菌过程的表征、开发、验证和常规控制的要求 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization pr
灭菌过程 |
2016 美国国家标准学会 |
| AS ISO 14160:2002 试验 |
给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管 Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid sterilants
生物负荷 |
2002 澳大利亚标准协会 |
| DIN EN ISO 14160:2018 规范标准 |
医疗保健产品灭菌使用动物组织及其衍生物的一次性医疗器械用液体化学灭菌剂灭菌产品的表征、开发、验证和常规控制要求 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
|
2018-05-01 德国标准化学会 |
| ISO 14160:2011 规范 |
保健产品消毒.使用动物组织以及衍生产品的一次性医用器具用液体消毒剂.消毒程序特性描述,开发确认以及常规控制的要求 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
生物负荷 |
2011-07 国际标准化组织 |
| ISO 14160:2020 试验/规范 |
一次性医疗器械的灭菌 包含动物产地的材料 - 液体化学杀菌剂的灭菌验证和常规控制 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, developmen
|
2020-09-21 国际标准化组织 |
| SS-EN ISO 14160:2011 规范标准 |
医疗保健产品的灭菌 利用动物组织及其衍生物的一次性医疗器械的液体化学灭菌剂 灭菌的特性、开发、验证和常规控制要求... Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization...
|
2011 瑞典标准研究所 |
| YY 0970-2013 试验标准 |
含动物源材料的一次性使用医疗器械的灭菌液体灭菌剂灭菌的确认与常规控制 Sterilization of single-use medical devices incorporating materials of animal origin.Validation and routine control of sterilization by liquid sterilants
|
2013-10-21 行业标准-医药 |
| YY 0970-2023 规范 |
医疗保健产品灭菌 一次性使用动物源性医疗器械的液体化学灭菌剂 医疗器械灭菌过程的特征、开发、确认和常规控制的要求 Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes
|
2023-03-14 行业标准-医药 |
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