11.080.01 消毒和灭菌综合 标准查询与下载

KS P ISO 11135:2008 医疗设备.用环氧乙烷消毒的批准和控制程序.工业湿热的消毒.

1.1 이 표준은 의료기기를 위한 산화에틸렌 멸균 과정의 확인과 일상관리를 위한 요구사항에

Medical devices－Validation and routine control of ethylene oxide sterilization

DS/EN ISO 15882:2008 保健品灭菌化学指标选择、使用和结果解释指南

1.1 This International Standard provides guidance for the selection, use and interpretation of resultsof chemical indicators used in process definition, validation and routine monitoring and overall controlof sterilization processes. This International Standard applies to indicators that show exposure tosterilization processes by means of physical and/or chemical change of substances, and which areused to monitor one or more of the variables required for a sterilization process. These chemicalindicators are not dependent for their action on the presence or absence of a living organism.1.2 This International Standard does not consider indicators for use in t

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results

DS/CEN ISO/TS 11135-2:2008 保健品灭菌-环氧乙烷-第2部分：ISO 11135-1应用指南

This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation.The exclusions in ISO 11135-1 apply also to this Technical Specification.For ease of reference, the clause numbering in this Technical Specification corresponds to that inISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C of ISO 11135-1:2007 and should be used in conjunction with this Technical Specification.This guidance document is intended for people who have a basic knowledge of the principles of EOsterilization but may need help in d

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1

EN ISO 15882:2008 医疗保健产品的灭菌化学指示剂选择,使用和检验结果的解释指南

This International Standard provides guidance for the selection; use and interpretation of results of chemical indicators used in process definition; validation and routine monitoring and overall control of sterilization processes.This International Standard applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances; and which are used to monitor one or more of the variables required of a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism.

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)

ISO 15882:2008 保健产品的消毒.化学指示剂.选择、使用和结果说明用指南

1.1 This International Standard provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. This International Standard applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required of a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism. 1.2 This International Standard does not consider indicators for use in those processes that rely on physical removal of microorganisms, e.g. filtration. 1.3 This International Standard is not intended to apply to indicators for use in combination processes, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place).

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results

CEN ISO/TS 11135-2:2008 卫生保健品的消毒.环氧乙烷.第2部分:ISO 11135-1应用指南

This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation.

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1

ISO 13408-1:2008 医疗保健产品的无菌加工.第1部分:一般要求

1.1 This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. 1.2 This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408. NOTE This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or pharmacopoeial requirements that pertain in particular national or regional jurisdictions.

Aseptic processing of health care products - Part 1: General requirements

SANS 11135-1:2008 保健产品的灭菌.乙撑氧.第1部分:医疗设备灭菌过程开发、确认和常规控制的要求

Specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. It does not: - detail a specified requirement for designating a medical device as sterile; - specify a quality mana

Sterilization of health care products - Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

GOST R ISO 11137-1-2008 健康医疗产品消毒.辐射.第1部分:医用设备消毒程序的常规控制验证和开发要求

Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices

GOST R ISO 11137-2-2008 健康医疗产品消毒.辐射.第2部分:设定消毒剂量

Sterilization of health care products. Radiation. Part 2. Establishing the sterilization dose

GOST R ISO 11137-3-2008 健康医疗产品消毒.辐射.第3部分:剂量测定指南

Sterilization of health care products. Radiation. Part 3. Guidance on dosimetric aspects

SANS 17664:2007 医疗器械的消毒．制造商提供的关于可重复消毒医疗器械的处理的信息

Specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor. It specifies requirements for the information t

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

DB11/ 409-2007 医院感染性疾病科室内空气卫生质量要求

本标准适用于各级各类医疗机构中的感染性疾病科病房、诊室。

Hygiene Standard of Indoor Air Quality for Infection diseases Department of Hospital

DB11/ 408-2007 医院洁净手术部污染控制规范

本标准适用于医院洁净手术部

Standard for the contaminant control in clean operating department of hospitals

ISO 11140-3:2007/cor 1:2007 卫生保健品的灭菌.化学指示剂.第3部分:布维-狄(Bowie and Dick)蒸汽渗透试验用2号指示剂系统.技术勘误1

This standard is about Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test; Technical Corrigendum 1

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test; Technical Corrigendum 1

LST EN ISO 11135-1:2007 保健品灭菌 环氧乙烷 第1部分：医疗器械灭菌过程的开发、验证和常规控制要求（ISO 11135-1:2007）

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

LST EN ISO 11140-4:2007 保健品灭菌 化学指示剂 第4部分：2 类指示剂作为用于检测蒸汽渗透的 Bowie 和 Dick 型试验的替代方法（ISO 11140-4:2007）

Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)

NF S98-101-1:2007 保健产品的灭菌.乙撑氧.第1部分:医疗设备灭菌过程开发、确认和常规控制的要求

Sterilization of health care products - Ethylene oxide - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices.

DS/ISO 11140-5:2007 保健品灭菌化学指示剂第5部分：Bowie和Dick型除气试验用2级指示剂

This part of ISO 11140 specifies the requirements for an indicator and alternative test system used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.Additionally, this part of ISO 11140 includes test methods and equipment used to meet these performance requirements.

Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests

DS/EN ISO 11135-1:2007 保健品灭菌-环氧乙烷-第1部分：医疗器械灭菌过程的开发、验证和常规控制要求

This standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices