11.080.20 消毒剂和防腐剂 标准查询与下载

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

GOST ISO 11135-2017 保健品灭菌 环氧乙烷 医疗器械灭菌过程的开发、验证和常规控制要求

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

16/30348019 DC BS EN 14476 AMD2 化学消毒剂和防腐剂 医学领域杀病毒活性评价的定量悬浮试验 测试方法和要求（第2阶段/步骤1）

BS EN 14476 AMD2. Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (Phase 2/Step 1)