11.080.20 消毒剂和防腐剂 标准查询与下载

DIN EN ISO 11135-1:2007 卫生保健品灭菌.环氧乙烷.第1部分:医疗设备灭菌过程的制定、确认和常规控制的要求(ISO 11135-1-2007)

This part of ISO 11135 specifies requirements for the development, validation and routine control of anethylene oxide sterilization process for medical devices. NOTE 1 Although the scope of this part of ISO 11135 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. Sterilization processes validated and controlled in accordance with the requirements of this part of ISO 11135 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE 2 See for example ISO 22442-1, ISO 22442-2 and ISO 22442-3. This part of ISO 11135 does not detail a specified requirement for designating a medical device as sterile. NOTE 3 Attention is drawn to national or regional requirements for designating medical devices as "sterile". See for example EN 556-1 or ANSI/AAMI ST67. This part of ISO 11135 does not specify a quality management system for the control of all stages of production of medical devices. NOTE 4 The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered to be elements of a quality management system. It is not a requirement of this part of ISO 11135 to have a complete quality management system during manufacture or reprocessing, 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). National and/or regional 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. This part of ISO 11135 does not specify requirements for occupational safety associated with the design and operation of ethylene oxide sterilization facilities. NOTE 5 For further information on safety, see examples in the Bibliography. National or regional regulations may also exist. NOTE 6 Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of regulations giving safety requirements for handling ethylene oxide and for premises in which it is used. This part of ISO 11135 does not cover sterilization by injecting ethylene oxide or mixtures containing ethylene oxide directly into individual product packages, or continuous sterilization processes. This part of ISO 11135 does not cover analytical methods for determining levels of residual ethylene oxide and/or its reaction products. NOTE 7 For further information see ISO 10993-7. NOTE 8 Attention is drawn to the possible existence of regulations specifying limits for the level of ethylene oxide residues present on or in medical devices and products.

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); English version of DIN EN ISO 11135-1:2007-08

DIN EN ISO 11140-3:2007 卫生保健产品的灭菌.化学指示剂.第3部分:真空灭菌锅残余空气蒸汽渗透试验用的2级指示剂体系

This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods,e.g.instruments and porous materials.The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Indicators complying with this part of ISO 11140 are intended ofr use in combination with the standard test pack as described in En 285.This part of ISO 11140 does not consider the performance of the standard test pack,but does specify the performance of the indicator systems.

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007); German version EN ISO 11140-3:2007

BS EN ISO 11135-1:2007 卫生保健品灭菌.环氧乙烷.医疗设备灭菌过程的制定、确认和常规控制的要求

ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. Sterilization processes validated and controlled in accordance with the requirements of ISO 11135-1:2007 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

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

NF S98-001-4*NF EN ISO 11140-4:2007 卫生保健产品的灭菌.化学指示剂.第4部分:蒸汽渗透检测用可代替真空灭菌锅残余空气测试的2类指示剂

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.

BS ISO 11140-5:2007 卫生保健品灭菌.化学指示剂.布维-狄(Bowie和Dick)型除气试验用2级指示剂

This part of ISO 11140 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests 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 - Class 2 indicators for Bowie and Dick-type air removal tests

ISO 11135-1:2007 卫生保健品灭菌.环氧乙烷.第1部分:医疗设备消毒过程的制定、确认和常规控制的要求

This part of ISO 11135 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. NOTE 1 Although the scope of this part of ISO 11135 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. Sterilization processes validated and controlled in accordance with the requirements of this part of ISO 11135 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE 2 See for example ISO 22442-1, ISO 22442-2 and ISO 22442-3. This part of ISO 11135 does not detail a specified requirement for designating a medical device as sterile. NOTE 3 Attention is drawn to national or regional requirements for designating medical devices as “sterile”. See for example EN 556-1 or ANSI/AAMI ST67. This part of ISO 11135 does not specify a quality management system for the control of all stages of production of medical devices. NOTE 4 The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered to be elements of a quality management system. It is not a requirement of this part of ISO 11135 to have a complete quality management system during manufacture or reprocessing, 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). National and/or regional 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. This part of ISO 11135 does not specify requirements for occupational safety associated with the design and operation of ethylene oxide sterilization facilities. NOTE 5 For further information on safety, see examples in the Bibliography. National or regional regulations may also exist. NOTE 6 Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of regulations giving safety requirements for handling ethylene oxide and for premises in which it is used. This part of ISO 11135 does not cover sterilization by injecting ethylene oxide or mixtures containing ethylene oxide directly into individual product packages, or continuous sterilization processes.

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

ANSI/AAMI/ISO 11140-3:2007 卫生保健品灭菌.化学指示剂.第3部分:布维-狄(Bowie和Dick)型蒸汽渗透试验用2级指示剂系统

Specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.

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

BS EN ISO 11140-3:2007 保健品灭菌.化学指示剂.蒸汽渗透布维-狄(Bowie和Dick)型试验2级指示剂系统

ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.

Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

BS EN ISO 11140-4:2007 保健品灭菌.化学指示剂.蒸汽渗透检测布维-狄(Bowie和Dick)型试验可选2级指示剂

ISO 11140-4:2007 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads). An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration. This part of ISO 11140-4:2007 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

Sterilization of health care products - Chemical indicators - Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

EN ISO 11140-4:2007 卫生保健产品的灭菌.化学指示剂.第4部分:蒸汽渗透检测用可代替真空灭菌锅残余空气试验的指示剂［代替:CEN EN 867-4］

Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dicktype test for detection of steam penetration

DIN EN 14476:2007 化学消毒剂和防腐剂.人用药物中化学消毒剂和防腐剂的病毒定量悬浮试验.试验方法和要求(阶段2,第1步)

This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectants or antiseptic products for instruments, surfaces or hands that form a homogeneous physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water. This document is applicable to a broad spectrum of viruses (Annex B) and 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 kindergartens, 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. It is impossible to determine the virucidal activity of the undiluted product as some dilution is always produced by ^ adding the inoculum and interfering substance. However, a disinfectant or antiseptic which is used in undiluted form 9 is tested in 80% concentration and shall pass this test prior to further assessment. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a phase 2, step 1 test (see Annex F).

Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and requirements (phase 2, step 1); English version of DIN EN 14476:2007-02

LST EN 14476+A1-2007 化学消毒剂和防腐剂 人用化学消毒剂和防腐剂杀病毒定量悬浮试验 试验方法和要求（第2阶段第1步）

Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and requirements (phase 2, step 1)

NF T72-185/IN1:2007 化学消毒剂和防腐剂.人类医学中使用的化学消毒剂和防腐剂的病毒定量悬浮试验.试验方法和要求(第2阶段第1步)

Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and requirements (phase 2, step 1).

NF T72-185:2007 化学消毒剂和防腐剂.人类医学中使用的化学消毒剂和防腐剂的病毒定量悬浮试验.试验方法和要求(第2阶段第1步)

Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and requirements (phase 2, step 1).

GOST R ISO 11140-3-2007 护理产品的消毒.化学指示剂.第3部分:蒸汽穿透测试纸2级显示

Sterilization of care products. Chemical indicators. Part 3. Class 2 indicators for steam penetration test sheets

NF S98-004-2:2006 医疗保健产品灭菌.生物指示物.第2部分:环氧乙烷灭菌同生物指示剂

Sterilization of health care products - Biological indicators - Part 2 : biological indicators for ethylene oxide sterilization processes.

NF S98-004-3:2006 医疗保健产品灭菌.生物指示物.第3部分:湿热灭菌用生物指示剂

Sterilization of health care products - Biological indicators - Part 3 : biological indicators for moist heat sterilization processes.

DIN EN ISO 11138-2:2006 医疗保健产品灭菌.生物指示物.第2部分:环氧乙烷灭菌同生物指示剂(ISO 11138-2:2006)

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 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 - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006); German version EN ISO 11138-2:2006

DIN EN ISO 11138-3:2006 医疗保健产品灭菌.生物指示物.第3部分:湿热灭菌用生物指示剂(ISO 11138-3:2006)

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 moist heat as the sterilizing agent. Moist heat as the sterilizing agent is defined in this part of ISO 11138 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 - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006); German version EN ISO 11138-3:2006

DS/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）

This 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 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 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 institut

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)