11.080.01 消毒和灭菌综合 标准查询与下载

GOST R 57507-2017 化学消毒剂. 浸渍织物和织物制成品的灭虱手段. 毒性和危险指标的研究方法

Chemical disinfectants. Pediculicide means for impregnation of fabrics and products from them. Methods of research of toxicity and danger indicators

GOST R 57473-2017 消毒学和消毒活动. 志愿者消毒剂试验规则

Disinfectology and disinfection activities. Rules for testing disinfectants on volunteers

GOST R 57469-2017 化学消毒剂. 污水消毒用消毒剂. 评定指南和效率指标

Chemical disinfectants. Disinfectants for the wastewater disinfection. Assessment criteria and efficiency indicators

GOST R 57474-2017 消毒学和消毒活动. 化学消毒剂和防腐剂. 季铵化合物的测定方法

Disinfectology and disinfection activities. Chemical disinfectants and antiseptics. Methods for determination of quaternary ammonium compounds

GOST R 57467-2017 化学消毒剂和防腐剂. 利用游动细胞(公牛的游动精子)模型的抗菌手段处理组织毒性的测定

Chemical disinfectants and antiseptics. Determination of toxicity of tissues treated with antibacterial means, on the model of motile cells (spermatozoids of bull)

GSO ISO 25424:2016 医疗器械灭菌 低温蒸汽和甲醛 医疗器械灭菌过程的开发、验证和常规控制要求

1.1 Inclusions 1.1.1 This European Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices. NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. 1.1.2 This European Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices. (See EN ISO 14937:2000, Table E.1) 1.1.3 This European Standard covers sterilization processes which use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only. 1.2 Exclusions 1.2.1 Sterilization processes validated and controlled in accordance with the requirements of this standard should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. 1.2.2 This standard does not specify requirements for designating a medical device as “STERILE”. Such requirements are given in EN 556-1. 1.2.3 This standard does not specify a quality management system for the control of all stages of production of medical devices. NOTE It is not a requirement of this standard to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see EN ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.2 of EN ISO 14937:2000. 1.2.4 This standard does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities. NOTE 1 Safety requirements for sterilizers are specified in EN 61010-2-040. NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements. 1.2.5 This European Standard does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products. NOTE 1 Attention is drawn to EN 14180. NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulation specifying limits for the level of formaldehyde residues on medical devices and products. 1.2.6 This European Standard does not cover preparatory measures that may be necessary before sterilization such as cleaning, disinfection and packing. NOTE For re-sterilizable medical devices, the manufacturer(s) of these devices should supply information on the preparatory measures (see EN ISO 17664).

Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices

GSO ISO 20857:2016 保健品灭菌 干热 医疗器械灭菌过程的开发、验证和常规控制要求

1.1 Inclusions 1.1.1 This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. NOTE Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that might be applicable to other health care products. 1.1.2 Although this International Standard primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat. NOTE Dry heat is often used for the depyrogenation of equipment, components and health care products and its effectiveness has been demonstrated. The process parameters for sterilization and/or depyrogenation are time and temperature. Because the conditions for depyrogenation are typically more severe than those required for sterilization, a process that has been validated for product depyrogenation will result in product sterility without additional validation. 1.2 Exclusions 1.2.1 This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3. 1.2.2 This International Standard does not apply to processes that use infrared or microwaves as the heating technique. 1.2.3 This International Standard does not detail a specified requirement for designating a medical device as "sterile." NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile.” See, for example, EN 556-1 or ANSI/AAMI ST67. 1.2.4 This International Standard does not specify a quality management system for the control of all stages of production of medical devices. NOTE It is not a requirement of this International Standard to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party. 1.2.5 This International Standard does not specify requirements for occupational safety associated with the design and operation of dry heat sterilization and/or depyrogenation facilities. NOTE Requirements for operational safety are specified in IEC 61010-2-040. Additionally, safety regulations exist in some countries.

Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices

JIS T 0801:2016 卫生保健品灭菌.环氧乙烷.医疗设备消毒过程的制定、确认和常规控制的要求

Sterilization of health care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices

YY/T 1402-2016 医疗器械蒸汽灭菌过程挑战装置适用性的测试方法

本标准规定了证实过程挑战装置在除气及蒸汽渗透方面比其模拟的医疗器械更难达到灭菌条件的测试方法。该过程挑战装置适用于符合GB 8599-2008要求的大型灭菌器和YY 0646-2008要求的小型灭菌器（含B型周期）。本标准中确认合格的过程挑战装置仅对被模拟的医疗器械有效。本标准没有规定过程挑战装置的设计及材料。

Test method to demonstrate the suitability of the process challenge device(PCD)during steam sterilization

YY/T 1276-2016 医疗器械干热灭菌过程的开发、确认和常规控制要求

本标准规定了医疗器械在干热灭菌过程中的开发、确认和常规控制要求。 本标准主要涉及干热灭茵，同时也规定了关于使用干热进行灭菌的去热原过程要求并提供相关指南。 本标准未规定用于灭活诸如羊痒病、牛海绵状脑病、克-雅病等海绵状脑病病原体的灭菌过程的开发、确认、常规控制的要求。 本标准不适用于红外线或微波灭菌。 本标准未详细规定标识为“无菌”的医疗器械，见EN 556-1的要求。 本标准未详述医疗器械产品所有生产阶段控制的质量管理体系。 本标准未规定与干热灭菌和去热原设备的设计和操作的相关职业安全要求。

Requirements for the development, validation and routine control of dry heat sterilization process for medical devices

ISO 18362:2016 基于细胞的健康护理产品的制造. 加工过程中的微生物风险控制

Manufacture of cell-based health care products - Control of microbial risks during processing

BS ISO 18362:2016 基于细胞的健康护理产品的制造. 加工过程中的微生物风险控制

Manufacture of cell-based health care products. Control of microbial risks during processing

YY/T 1464-2016 医疗器械灭菌低温蒸汽甲醛灭菌过程的开发、确认和常规控制要求

适用 本标准规定了医疗器械低温蒸汽甲醛灭菌过程的开发、确认和常规控制的要求。 本标准适用于过程开发者、灭菌设备制造商、被灭菌的医疗器械制造商和负责医疗器械灭菌的单位进行医疗器械的灭菌(见GB/T 19974 - 2005中表E.1)。 本标准覆盖了使用混合低温蒸汽甲醛作为灭菌剂、仅在低于环境压力工作的灭菌过程。 不适用 本标准未规定对海绵状脑病(如羊痒症、牛海绵状脑病和克雅症)病原体灭活过程的开发、确认和常规控制的要求。对于处理潜在受这些病原体污染的材料，某些国家制定了特殊的规范。 本标准未详述标示“无菌”医疗器械的特定要求。 本标准未规定控制医疗器械生产的所有阶段的质量管理体系。 本标准未规定与低温蒸汽甲醛灭菌设施的设计和运行相关的职业安全要求。 本标准不包括确定水平或残留的甲醛和/或它的反应产物的分析方法。 本标准不包括一些灭菌前所需的预处理工作，如清洁、消毒与包装。

Sterilization of medical devices.Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices

YY/T 1463-2016 医疗器械灭菌确认.选择微生物挑战和染菌部位的指南

本标准为灭菌确认过程中选择合适的微生物挑战、合适的染菌部位、染菌方法以及复苏染菌微生物的技术提供相应的指南。本标准适用于医疗器械制造商进行灭菌确认试验，而不适用于常规的灭菌试验。本标准不适用于医疗器械清洁效果确认或消毒确认中的微生物挑战或染菌过程。

Sterilization validation of medical device.Guidance on selecting a microbial challenge and inoculation sites

GOST 8.651-2016 确保测量一致性的国家体系. 医疗产品. 辐射灭菌. 剂量测定技术

State system for ensuring the uniformity of measurements. Medical products. Radiation sterilization. Dosimetric techniques

GOST R 56998-2016 化学消毒剂和防腐剂. 非集中供水系统饮用水的消毒方法. 毒性和危险

Chemical disinfectants and antiseptics. Means for disinfection of non-centralized water systems drinking water. The toxicity and danger

GOST R 56994-2016 消毒学和消毒活动. 术语和定义

Disinfectology and disinfection activities. Terms and definitions

GOST R 56996-2016 化学消毒剂和防腐剂. 泳池池水的消毒方式. 毒性和危险

Chemical disinfectants and antiseptics. Means for disinfection of water in swimming pools. The toxicity and danger

GOST R 56999-2016 消毒学和消毒活动. 化学消毒剂和防腐剂. 饮用水中二氧化氯的测定方法

Disinfectology and disinfection activities. Chemical disinfectants and antiseptics. Method for the determination of chlorine dioxide in drinking water

GOST R 57001-2016 消毒学和消毒活动. 化学消毒剂和防腐剂. 氯含量的测定方法

Disinfectology and disinfection activities. Chemical disinfectants and antiseptics. Method for the determination of chlorine content