11.080.20 消毒剂和防腐剂 标准查询与下载

DS/EN 14562:2006 化学消毒剂和防腐剂 用于评价医疗领域使用的仪器的杀真菌或杀酵母活性的定量载体试验 试验方法和要求（第 2 阶段，第 2 步）

This standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant products for instruments that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water. This standard applies to products that are used in the medical area for disinfecting instruments by immersion - even if they are not covered by the EEC/93/42 Directive on Medical Devices.This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:- in hospitals, in community med

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

DIN EN ISO 11138-5:2006 医疗保健产品灭菌.生物指示物.第5部分:低温蒸汽和甲醛灭菌过程用生物指示物

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006

BS EN ISO 11138-3:2006 医疗保健产品灭菌.生物指示物.湿热灭菌处理用生物指示剂

ISO 11138-3:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. Moist heat as the sterilizing agent is defined in ISO 11138-3:2006 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.

Sterilization of health care products - Biological indicators - Biological indicators for moist heat sterilization processes

DIN EN 14562:2006 化学消毒剂和防腐剂.评估医学领域用器械灭真菌或酵母菌作用的定量病媒试验.试验方法和要求(第2阶段，第2步)

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) English version of DIN EN 14562:2006-08

BS EN ISO 11138-1:2006 医疗保健产品灭菌.生物指示物.一般要求

ISO 11138-1:2006 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.ISO 11138-1:2006 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.

Sterilization of health care products - Biological indicators - General requirements

BS EN ISO 11138-2:2006 医疗保健产品灭菌.生物指示物.环氧乙烷灭菌用生物指示剂

ISO 11138-2:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.

Sterilization of health care products - Biological indicators - Biological indicators for ethylene oxide sterilization processes

BS EN ISO 11138-4:2006 医疗保健产品灭菌.生物指示物.干热灭菌用生物指示剂

ISO 11138-4:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators, and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.

Sterilization of health care products - Biological indicators - Biological indicators for dry heat sterilization processes

BS EN ISO 11138-5:2006 医疗保健产品灭菌.生物指示物.低温蒸汽和甲醛灭菌用生物指示剂

ISO 11138-5:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.

Sterilization of health care products - Biological indicators - Biological indicators for low-temperature steam and formaldehyde sterilization processes

LST EN 14562-2006 化学消毒剂和防腐剂 用于评价医疗领域使用的仪器的杀真菌或杀酵母活性的定量载体试验 试验方法和要求（第 2 阶段，第 2 步）

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

LST EN 14561-2006 化学消毒剂和防腐剂 用于评价医疗领域用仪器杀菌活性的定量载体试验 试验方法和要求（第 2 阶段，第 2 步）

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

ISO 11138-1:2006 医疗保健产品灭菌.生物指示物.第1部分:一般要求

1.1 General 1.1.1 This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. 1.1.2 This part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies. NOTE National or regional regulations may apply. 1.2 Exclusions This part of ISO 11138 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This part of ISO 11138, however, could contain elements relevant to such microbiological test systems.

Sterilization of health care products - Biological indicators - Part 1: General requirements

ISO 11138-4:2006 医疗保健产品灭菌.生物指示器.第4部分:干热灭菌处理用生物指示器

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators, and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C. NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 14937. NOTE 2 Requirements for work place safety may be provided by national or regional regulations.

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes

ISO 11138-5:2006 医疗保健产品灭菌.生物指示器.第5部分:低温蒸汽和甲醛溶液灭菌处理用生物指示器

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent. NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937. NOTE 2 Requirements for work place safety may be provided by national or regional regulations.

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

BS EN 14562:2006 化学消毒剂和防腐剂.评估医学领域用器械灭真菌或酵母菌作用的定量病媒试验.试验方法和要求(第2阶段，第1步)

This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant products for instruments that form a homogeneous, physically stable preparation when diluted with hard water – or in the case of ready-to-use products – with water. This European Standard applies to products that are used in the medical area for disinfecting instruments by immersion – even if they are not covered by the EEC/93/42 Directive on Medical Devices. This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:  in hospitals, in community medical facilities and in dental institutions;  in clinics of schools, of kindergardens and of nursing homes; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients. NOTE This method corresponds to a phase 2, step 2 test (see Annex E).

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

BS EN 14561:2006 化学消毒剂和防腐剂.评估医学领域用器械灭菌作用的定量病媒试验.试验方法和要求(第2阶段，第1步)

This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water – or in the case of ready-to-use products – with water. This European Standard applies to products that are used in the medical area for disinfecting instruments by immersion – even if they are not covered by the EEC/93/42 Directive on Medical Devices. This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:  in hospitals, in community medical facilities and in dental institutions;  in clinics of schools, of kindergardens and of nursing homes;  and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients. NOTE This method corresponds to a phase 2, step 2 test (see Annex E).

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

BS EN ISO 18472:2006 保健产品的消毒.生物和化学指示剂.试验设备和方法

ISO 18472:2006 specifies the requirements for test equipment to be used to test chemical and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 11140-1 for chemical indicators, or the requirements given in the ISO 11138 series for biological indicators. ISO 18472:2006 also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing.

Sterilization of health care products - Biological and chemical indicators - Test equipment and methods

EN ISO 18472:2006 保健产品的消毒.生物和化学指示剂.试验器械 ISO 18472-2006

1.1 This International Standard specifies the requirements for test equipment to be used to test chemical and biological indications for steam,ethylene oxide,dry heat and vaporized hydrogen peroxide process for ISO 11138 series for biological Indicators.This International Standard also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing.ISO 11138-2,ISO 11138-3,ISO 11138-4,and ISO 11140-1 require the use of resistometers specified in this International Standard,and these resistometers are used in conjunction with the test methods specified in the

Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006)

ISO 18472:2006 保健产品的消毒.生物和化学指示剂.试验器械

1.1 This International Standard specifies the requirements for test equipment to be used to test chemical and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 11140-1 for chemical indicators, or the requirements given in the ISO 11138 series for biological indicators. This International Standard also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing. ISO 11138-2, ISO 11138-3, ISO 11138-4, and ISO 11140-1 require the use of resistometers specified in this International Standard, and these resistometers are used in conjunction with the test methods specified in the appropriate parts of ISO 11138 and ISO 11140. NOTE Resistometers for formaldehyde indicators are not included in this International Standard. Test methods using laboratory apparatus for steam-formaldehyde are included in ISO 11138-5, ISO 11140-3 and ISO 11140-4. 1.2 This International Standard does not address the methods used to demonstrate compliance of biological or chemical indicators to ISO 11138 and ISO 11140, as these are covered in the appropriate parts of these standards. Indicators used with combination processes, such as washer-disinfection, are not covered by this International Standard. NOTE Test equipment and methods necessary for ISO 11140-3, ISO 11140-4 or ISO 11140-5 are specified in those standards. 1.3 This International Standard does not address safety aspects of the test equipment because these are usually covered by specific regional, national or local regulations.

Sterilization of health care products - Biological and chemical indicators - Test equipment

EN 14561:2006 化学消毒剂和防腐剂.评估医学领域用器械灭菌作用的定量病媒试验的试验方法和要求(第2阶段,第2步骤)

This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water – or in the case of ready-to-use products – with water.This European Standard applies to products that are used in the medical area for disinfecting instruments by immersion – even if they are not covered by the EEC/93/42 Directive on Medical Devices.This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: in hospitals, in community medical faciliti

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

EN 14562:2006 化学消毒剂和防腐剂.评估医学领域用器械灭真菌或酵母菌作用的定量病媒试验的试验方法和要求(第2阶段,第2步)

This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant products for instruments that form a homogeneous, physically stable preparation when diluted with hard water – or in the case of ready-to-use products – with water. This European Standard applies to products that are used in the medical area for disinfecting instruments by immersion – even if they are not covered by the EEC/93/42 Directive on Medical Devices.This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: in hospitals,

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)