11.080.20 消毒剂和防腐剂 标准查询与下载

DIN EN ISO 14161:2010 医疗保健产品的消毒.生物指示剂.选择、使用和检验结果解释指南(ISO 14161-2009); 德文版本 EN ISO 14161-2009

This International Standard provides guidance for the selection, use, and interpretation of results from application of biological indicators when used in the development, validation, and routine monitoring of sterilization processes. This International Standard applies to biological indicators for which International Standards exist.

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009); German version EN ISO 14161:2009

BS EN ISO 11140-3:2009 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

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 for 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 - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

BS EN ISO 11140-3:2010 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

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

DIN ISO/TS 11135-2:2010 卫生保健品的消毒.环氧乙烷.第2部分:ISO 11135-1应用指南(ISO/TS 11135-2-2008).德文版本CEN ISO/TS 11135-2-2008,DIN ISO/TS 11135-2-2008-11标准的勘误表.德文版本CEN ISO/TS 11135-2-2008/AC-2009

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. This Technical Specification addresses ethylene ooxide sterilization in both the industrial and health care facility settings, and it acknowldges the similarities and differences between the two applications.

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008); German version CEN ISO/TS 11135-2:2008, Corrigendum to DIN ISO/TS 11135-2:2008-11; German version CEN ISO/TS 11135-2:2008/AC

ASTM E1891-10a 测定抗菌剂抗选定微生物的生存曲线和计算D值及浓度系数的标准指南

The different procedures and methods are designed to be used to produce survival data after microorganisms are exposed to antimicrobial agents in order to calculate values that can be used to analyze and rationalize the effectiveness of antimicrobial agents when tested using other, often applied test methods. The data from these test procedures may be used in the selection and design of other tests of effectiveness of antimicrobial agents, some of which may be required by regulatory agencies to establish specific claims. Basic kinetic information about killing rate often serves as the initial information on which a testing program can be built.1.1 This guide covers the methods for determining the death rate kinetics expressed as D-values. These values can be derived from the construction of a kill curve (or survivor curve) or by using other procedures for determining the number of survivors after exposure to antimicrobial chemicals or formulations. Options for calculations will be presented as well as the method for calculation of a concentration coefficient. 1.1.1 The test methods are designed to evaluate antimicrobial agents in formulations to define a survivor curve and to subsequently calculate a D-value. The tests are designed to produce data and calculate values that provide basic information of the rate-of-kill of antimicrobial formulations tested against single, selected microorganisms. In addition, calculated D-values from survivor curves from exposure at different dilutions of antimicrobial can be used to show the effect of dilution by calculation of the concentration exponent, η (2). 1.1.2 As an example of potential use of kill curve data, the published FDA, OTC Tentative Final Monograph for Health-Care Antiseptic Drug Products, Proposed Rule, June 17, 1994 has suggested the testing of topically applied antimicrobial products using survival curve (or kill curve) calculations. The methods described in this guide are applicable to these products, but adjustments such as the use of antifoaming agents when the reaction mixture is stirred may be necessary to counteract the presence of detergents in many formulations. Frequently the sampling for these tests is done after very short intervals of exposure to the formulation, such as 30 and 60 s. This methodology also has been applied to preservative testing of antimicrobial ingredients in more complex cosmetic formulations (5). 1.2 The test methods discussed should be performed only by those trained in microbiological techniques. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient

ASTM E1891-10 测定抗选定微生物的抗菌剂的生存曲线和计算D值及浓度系数的标准指南

The different procedures and methods are designed to be used to produce survival data after microorganisms are exposed to antimicrobial agents in order to calculate values that can be used to analyze and rationalize the effectiveness of antimicrobial agents when tested using other, often applied test methods. The data from these test procedures may be used in the selection and design of other tests of effectiveness of antimicrobial agents, some of which may be required by regulatory agencies to establish specific claims. Basic kinetic information about killing rate often serves as the initial information on which a testing program can be built.1.1 This guide covers the methods for determining the death rate kinetics expressed as D-values. These values can be derived from the construction of a kill curve (or survivor curve) or by using other procedures for determining the number of survivors after exposure to antimicrobial chemicals or formulations. Options for calculations will be presented as well as the method for calculation of a concentration coefficient. 1.1.1 The test methods are designed to evaluate antimicrobial agents in formulations to define a survivor curve and to subsequently calculate a D-value. The tests are designed to produce data and calculate values that provide basic information of the rate-of-kill of antimicrobial formulations tested against single, selected microorganisms. In addition, calculated D-values from survivor curves from exposure at different dilutions of antimicrobial can be used to show the effect of dilution by calculation of the concentration exponent, η (2). 1.1.2 As an example of potential use of kill curve data, the published FDA, OTC Tentative Final Monograph for Health-Care Antiseptic Drug Products, Proposed Rule, June 17, 1994 has suggested the testing of topically applied antimicrobial products using survival curve (or kill curve) calculations. The methods described in this guide are applicable to these products, but adjustments such as the use of antifoaming agents when the reaction mixture is stirred may be necessary to counteract the presence of detergents in many formulations. Frequently the sampling for these tests is done after very short intervals of exposure to the formulation, such as 30 and 60 s. This methodology also has been applied to preservative testing of antimicrobial ingredients in more complex cosmetic formulations (5). 1.2 The test methods discussed should be performed only by those trained in microbiological techniques. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient

ASTM E2756-10 有关抗菌剂和抗病毒剂的标准术语

1.1 The purpose of this terminology standard is to establish uniformity in terms used in the field of antimicrobial and antiviral agent testing. Terms are adapted from related fields such as regulatory terms defined by law and definitions as supported by test requirements. 1.2 The terms are appropriate to the wide range of interest related to standards developed in the area of antimicrobial and antiviral testing.

Standard Terminology Relating to Antimicrobial and Antiviral Agents

ASTM E2752-10(2015) 评估抑菌个人清洁用品剩余效力的标准指南

5.1 The procedure is used to evaluate personal cleansing products containing antibacterial ingredients that are intended to reduce the number of organisms on intact skin. It also may be used to demonstrate the effect of residual antibacterial activity by means of inhibition of the proliferation of bacteria on the skin after contact. 1.1 This guide is designed to demonstrate the effectiveness of an antibacterial personal cleansing product in reducing the numbers of a marker organism (representing transients) both immediately and after prolonged exposure to (cleansing) washing when used as recommended under simulated use conditions. The method demonstrates the effect of residual antibacterial activity by means of inhibition of proliferation of bacteria on the skin after the contact period. Antimicrobial activity is compared with a vehicle or to a baseline organism count. 1.2 A knowledge of microbiological techniques is required for these procedures. 1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (21 CFR Parts 50 and 56). 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products

BS EN ISO 11138-3:2009 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

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. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by ISO 17665. NOTE 2 National or regional regulations may provide requirements for work place safety.

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

BS EN ISO 11138-2:2009 医疗保健产品灭菌.生物指示剂.环氧乙烷灭菌用生物指示剂

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. NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135. NOTE 2 National or regional regulations could provide requirements for work place safety.

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

BS EN ISO 11140-1:2009 保健产品的灭菌.化学指示剂.一般要求

1.1 This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism. NOTE Biological test systems are regarded as those tests which are dependent for their interpretation on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 series for biological indicators (BIs). 1.2 The requirements and test methods of this part of ISO 11140 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply. Relevant test equipment is described in ISO 18472. NOTE Additional requirements for specific test indicators (Class 2 indicators) are given in ISO 11140-3, ISO 11140-4 and ISO 11140-5.

Sterilization of health care products - Chemical indicators - General requirements

DIN EN ISO 11140-1:2009 保健产品的消毒.化学指示剂.第1部分:一般要求(ISO 11140-1-2005).英文版本DIN EN ISO 11140-1-2009-09

1.1 This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism. NOTE Biological test systems are regarded as those tests which are dependent for their interpretation on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 sedes for biological indicators (BIs). 1.2 The requirements and test methods of this part of ISO 11140 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply. Relevant test equipment is described in ISO 18472. NOTE Additional requirements for specific test indicators (Class 2 indicators) are given in ISO 11140-3, ISO 11140-4 and ISO 11140-5.

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); English version of DIN EN ISO 11140-1:2009-09

DIN EN ISO 11140-3:2009 保健产品的灭菌.化学指示剂.第3部分:Bowie和Dick型蒸汽渗透试验用2级指示剂系统(ISO 11140-3-2007,包括Cor 1-2007).英文版本DIN EN ISO 11140-3-2009-09

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 for 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, including Cor 1:2007); English version of DIN EN ISO 11140-3:2009-09

DIN EN ISO 11138-2:2009 保健产品的灭菌.生物指示剂.第2部分:环氧乙烷灭菌过程的生物指示器(ISO 11138-2-2006).英文版本DIN EN ISO 11138-2-2009-09

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℃ to 65℃. NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135. NOTE 2 National or regional regulations could provide requirements for work place safety.

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006); English version of DIN EN ISO 11138-2:2009-09

DIN EN ISO 11138-3:2009 保健产品的消毒.生物指示剂.第3部分:湿热消毒过程的生物指示剂(ISO 11138-2-2006).英文版本DIN EN ISO 11138-3-2009-09

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. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by ISO 17665. NOTE 2 National or regional regulations may provide requirements for work place safety.

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-2:2006); English version of DIN EN ISO 11138-3:2009-09

NF S98-004-2:2009 卫生保健产品的消毒.生物指示剂.第2部分:环氧乙烷消毒方法的生物指示剂

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

NF S98-001-1:2009 卫生保健产品的消毒.化学指示剂.第1部分:一般要求

Sterilization of health care products - Chemical indicators - Part 1 : general requirements.

NF S98-004-3:2009 卫生保健产品的消毒.生物指示剂.第3部分:湿热消毒工方法的生物指示剂

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

BS DD CEN ISO/TS 11135-2:2009 保健品消毒 环氧乙烷 ISO 11135-1应用指南

Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1

NF S98-015/IN1:2009 医用灭菌器.环氧乙烷灭菌器.试验方法和要求

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods.