11.080.20 消毒剂和防腐剂 标准查询与下载

ASTM D8179-18 临床用医疗器械清洁用洗涤剂特性的标准指南

1.1 Detergents play a critical role in the cleaning of clinically-used medical devices, but there are few consensus methods for describing the key characteristics of these detergents. This guide identifies consensus standards, ASTM and others, used to characterize detergents in other applications, which can also be used to characterize detergents used to clean clinically-used medical devices. 1.2 In identifying these test methods, manufacturers of detergents can reference this guide to characterize their detergents. 1.3 By identifying applicable test methods, gaps may be identified where development of new standardized test methods need to be developed to characterize detergents intended to clean medical devices. 1.4 By identifying applicable test methods that are used and results reported by detergent manufacturers, test results can be shared and may lead in the future to development of performance criteria for the key characteristics of detergent. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 Exclusions: 1.6.1 This guide is not intended for detergents formulated to remove residues as a result of the manufacturing process. 1.6.2 This guide does not provide information related to disinfection or disinfecting agents that might be part of a detergent formulation. 1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices

SANS 2231:2018 通用酒精基产品杀菌效果的研究

Specifies a method to determine the bactericidal efficacy of alcohol based products intended for general use.

Bactericidal efficacy of alcohol based products intended for general use

SANS 1781:2018 生物基处理产品

Specifies characteristics and requirements for biologically based treatment products for bioremediation, bio-augmentation, and biodegradation.

Biological based treatment products

ASTM E3092-18 标准实践评估污染物的蒸气去污染物的功效芽孢杆菌孢子并含于0.2

1.1 This practice is used to quantify the efficacy of vaporous decontaminants on Bacillus spores dried on the surface of coupons made from porous and non-porous materials and contained within 0.2µm filter-capped tubes. 1.2 This practice should be performed only by those trained in microbiological techniques, are familiar with antimicrobial (sporicidal) agents and with the end use of such products. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Practice for Evaluating Efficacy of Vaporous Decontaminants on Materials Contaminated with Bacillus Spores and Contained Within 0.2µm Filter-Capped Tubes

GOST R 58151.3-2018 消毒剂 理化参数测定方法

Disinfectants. Methods for determining physical and chemical parameters

GOST R 58151.1-2018 消毒剂 一般技术要求

Disinfectants. General technical requirements

GOST R 58151.2-2018 消毒剂 毒性和安全值命名法

Disinfectants. Toxicity and safety values nomenclature

GOST R 58151.4-2018 消毒剂 确定效率因素的方法

Disinfectants. Methods for determining efficiency factor

ASTM E1115-11(2017) 评估外科手部磨砂配方的标准试验方法

1.1 This test method is designed to measure the reduction of microbial flora on the skin. It is intended for determining both immediate and persistent (continuing antimicrobial effect) microbial reductions, after single or repetitive treatments, or both. It may also be used to measure cumulative antimicrobial activity after repetitive treatments. 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. 1.4.1 In this test method, SI units are used for all applications, except for distance, in which case inches are used and SI units follow in parentheses. 1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Test Method for Evaluation of Surgical Hand Scrub Formulations

ASTM E1482-12(2017) 用于细胞毒性降低和中和的凝胶过滤柱的标准实施规程

NOTE 1—The title was formerly Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations. 1.1 This practice is intended to be used to reduce the cytotoxic level of the virus-test product mixture prior to assaying for viral infectivity. It is used in conjunction with evaluations of the virucidal efficacy of disinfectant solutions, wipes, trigger sprays, or pressurized disinfectant spray products intended for use on inanimate, nonporous environmental surfaces. This practice may also be used in the evaluation of hygienic handwashes/handrubs, or for other special applications. The practice may be employed with all viruses and host systems. 1.2 This practice should be performed only by persons trained in virology techniques. 1.3 This practice utilizes gel filtration technology. The effectiveness of the practice is dependent on the ratio of gel bed volume to sample size and uniformity in the preparation of columns as well as the conditions of entrifugation. The effectiveness of this practice is maximized by investigator practice and experience with gel filtration techniques. 1.4 This practice will aid in the reduction, but not necessarily elimination, of test product toxicity while preserving the titer of the input virus. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization

DIN EN ISO 11138-2:2017 保健品灭菌-生物指示剂-第2部分：环氧乙烷灭菌过程的生物指示剂（ISO 11138-2:2017）；德文版 EN ISO 11138-2:2017

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017); German version EN ISO 11138-2:2017

DIN EN ISO 11138-4:2017 保健品灭菌-生物指示剂-第4部分：干热灭菌过程的生物指示剂（ISO 11138-4:2017）；德文版 EN ISO 11138-4:2017

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017); German version EN ISO 11138-4:2017

DIN EN ISO 11138-5:2017 保健品灭菌-生物指示剂-第5部分：低温蒸汽和甲醛灭菌过程的生物指示剂（ISO 11138-5:2017）；德文版 EN ISO 11138-5:2017

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017); German version EN ISO 11138-5:2017

DIN EN ISO 11138-3:2017 保健品灭菌-生物指示剂-第3部分：湿热灭菌过程的生物指示剂（ISO 11138-3:2017）；德文版 EN ISO 11138-3:2017

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017); German version EN ISO 11138-3:2017

DIN EN ISO 11138-1:2017 保健品灭菌-生物指标-第1部分：一般要求（ISO 11138-1:2017）；德文版 EN ISO 11138-1:2017

Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017); German version EN ISO 11138-1:2017

EN ISO 11138-5:2017 医疗保健产品的灭菌生物指示剂-第5部分:低温蒸汽甲醛灭菌生物指示剂的过程(ISO 11138-5:2017)

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

EN ISO 11138-3:2017 医疗保健产品的灭菌生物指示剂-第3部分:湿热灭菌过程的生物指标(ISO 11138-3:2017)

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

EN ISO 11138-4:2017 医疗保健产品的灭菌生物指示剂-第4部分:干热灭菌生物指示剂的过程(ISO 11138-4:2017)

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

EN ISO 11138-1:2017 医疗保健产品的灭菌生物指示剂-第1部分:一般要求(ISO 11138-1:2017)

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

EN ISO 11138-2:2017 医疗保健产品的灭菌生物指示剂-第2部分:环氧乙烷灭菌生物指示剂的过程(ISO 11138-2:2017)

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