11.080.20 消毒剂和防腐剂 标准查询与下载

GB/T 39873-2021 消毒剂中季铵盐的测定 液相色谱-串联质谱法

本文件规定了液相色谱-串联质谱法测定消毒剂中季铵盐的试剂和材料、仪器和设备、测定步骤、结果计算、精密度、检出限和定量限。 本文件适用于消毒剂中十二烷基二甲基苄基氯化铵(C12 -BAC)、十四烷基二甲基苄基氯化铵(C14 BAC)、十六烷基二甲基苄基氯化铵(C16 -BAC)、二癸基二甲基氯化铵(DDAC)、十二烷基三甲基溴化铵(DTAB)、十二烷基二甲基2 -苯氧基-乙基溴化铵(EDDAB)的测定。

Determination of quaternary ammonium salt in disinfectant—Liquid chromatography-tandem mass spectrometry

BS EN 17430:2024 化学消毒剂和防腐剂 卫生洗手液具有杀病毒作用 测试方法和要求（第2阶段/步骤2）

Chemical disinfectants and antiseptics. Hygienic handrub virucidal. Test method and requirements (phase 2/step 2)

ASTM D8179-18(2024) 信息安全、网络安全和隐私保护 IT 安全评估标准 预定义的安全要求包

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

BS EN 17846:2023 化学消毒剂和防腐剂 用于评估医疗领域中使用擦拭布的机械作用对无孔表面上的艰难梭菌杀孢子活性的定量测试方法（4 场……

Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of sporicidal activity against Clostridioides difficile on non-porous surfaces with mechanical action employing wipes in the medical area (4-field…

T/TIC 009-2023 抑菌凝胶

本文件规定了抑菌凝胶的原料要求、技术要求、检验方法、检验规则及标志、标签、包装、运输、 贮存、产品认证。

antibacterial gel

T/TIC 008-2023 抑菌液

本文件规定了抑菌液的原料要求、技术要求、检验方法、检验规则及标志、标签、包装、运输、贮 存等。

Antibacterial liquid

T/CIET 252-2023 次氯酸钙溶液

本文件规定了次氯酸钙溶液的要求、采样、试验方法、检验规则及标志、包装、运输、贮存、安全。 本文件适用于钠法生产次氯酸钙过程中产生的次氯酸钙溶液。

Calcium hypochlorite solution

T/ZHCA 604-2023 消毒产品中激素含量的测定液相色谱?串联质谱法

1范围 2规范性引用文件 3术语和定义 4原理 5试剂和材料 5.1试剂 5.2材料 5.3标准品 5.4标准溶液的配制 6仪器和设备 7分析步骤 7.1样品前处理 7.2测定步骤 7.3定性测定 7.4定量测定 7.5平行试验 7.6空白试验 7.7结果计算和表述 8 检出限和定量限 9 允许差 10 回收率 11 其他激素类药物的检测方法

Determination of hormone components in disinfection products—LC-MS-MS

ASTM E1482-23 细胞毒性降低和中和用凝胶过滤柱的使用标准实施规程

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. NOTE 1—Gel filtration columns may impact virus titer and their use should be taken into consideration when selected for use. 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 centrifugation. 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 Units—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

T/HATSI 0022-2023 绿色设计产品评价技术规范 次氯酸氧化高电位消毒液

该标准包括范围、规范性引用文件、术语和定义、评价要求、产品生命周期评价报告编制方法、评价方法共6个章节。

Technical specification for green-design product assessment—High oxidation potential disinfectant with hypochlorite

23/30454767 DC BS EN 17122:2019/prA1 化学消毒剂和防腐剂 用于评估兽医领域使用的化学消毒剂和防腐剂的杀病毒活性的定量无孔表面测试 测试方法及要求...

BS EN 17122:2019/prA1 Chemical disinfectants and antiseptics. Quantitative nonporous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area. Test method and requirements.…

22/30460212 DC BS EN 16615 化学消毒剂和防腐剂 用机械方法评估无孔表面的杀菌和杀酵母和/或杀真菌和/或杀结核菌和/或杀分枝杆菌活性的定量测试方法...

BS EN 16615. Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity on non-porous surfaces with mechanical…

BS EN 16616:2022 化学消毒剂和防腐剂 化学热纺织品消毒 测试方法和要求（第2阶段 步骤2）

1   Scope This document specifies a test method and the minimum requirements for the microbicidal activity of a specified disinfection process for the treatment of contaminated textile . This procedure is carried out by using a washing machine as specified in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers' instructions are expected to be sufficient if they content the process parameters identified in the test (e.g. dosing disinfectant in whatever washing phase e.g. main wash, rinsing, disinfecting at 40 °C). This document 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 kindergartens, and of nursing homes; and could occur in the workplace and in the home. It could also include services such as laundries and kitchens supplying products directly for the patients. The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the product. EN 14885 specifies in detail the relationship of the various tests ...

Chemical disinfectants and antiseptics. Chemical-thermal textile disinfection. Test method and requirements (phase 2, step 2)

ASTM E1153-22 无生命非食品接触面用推荐的消毒器的效力的测试

1.1 This test method is used to evaluate the antimicrobial efficacy of sanitizers on precleaned, inanimate, hard, nonporous, non-food contact surfaces against Staphylococcus aureus, or Klebsiella pneumoniae or Klebsiella aerogenes, or a combination thereof. Appropriate modifications to the method may be required when testing organisms not specified herein. When utilizing test surfaces not described herein (see Test Method E2274) or when evaluating spray-based or towelettebased antimicrobial products, modifications may also be required. 1.2 This test method may also be used to evaluate the antimicrobial efficacy of one-step cleaner-sanitizer formulations recommended for use on lightly soiled, inanimate, nonporous, non-food contact surfaces. 1.3 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP) are required and to follow them where appropriate (see section 40 CFR, 160 or as revised.) 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, chemicals and microorganisms and should be performed only by persons who have had formal microbiological training. 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 Efficacy of Sanitizers Recommended for Inanimate, Hard, Nonporous Non-Food Contact Surfaces

ASTM E1054-22 抗菌剂灭活剂评价的标准实施规程

1.1 These test procedures are used to determine the effectiveness of methodologies procedures and materials intended for inactivating (neutralizing, quenching) the microbicidal properties of antimicrobial agents; to ensure that no components of the neutralizing procedures and materials, themselves, exert an inhibitory effect on microorganisms targeted for recovery; and to demonstrate that the antimicrobial chemistry tested is microbicidal. 1.2 Knowledge of microbiological and statistical techniques is required for these procedures. NOTE 1—These methods are not suitable when testing the virucidal activity of microbicides (see Test Method E1482). 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 Practices for Evaluation of Inactivators of Antimicrobial Agents

CEN/TR 17825:2022 化学消毒剂和防腐剂 EN 16615:2015 中水控制的解读

This document defines rules for the interpretation of data according to EN 16615: 2015 regarding water controls in order to avoid problems in discussions with legal bodies on the validity of data to support product claims.

Chemical disinfectants and antiseptics - Interpretation of water controls in EN 16615:2015

22/30457246 DC BS EN 17430 化学消毒剂和防腐剂 卫生洗手液具有杀病毒作用 测试方法和要求（第2阶段 步骤2）

BS EN 17430. Chemical disinfectants and antiseptics. Hygienic handrub virucidal. Test method and requirements (phase 2, step 2)

T/SDA 001-2022 次氯酸消毒液卫生要求

1. 产品应无色透明，无分层，无析出，无结晶，无沉淀和悬浮物。 2. 产品应标示有效氯含量、次氯酸含量及范围，范围应在标示中值的±15%以内，其中，次氯酸含量应大于有效氯的50%。 3. 产品pH值应在4.0~7.0，且波动范围为中值±1.0。 4、产品有效期不得少于6个月，在产品有效期内，含量不得低于标示值的下限。

Hygienic requirements for hypochlorous acid disinfectant

YY/T 0681.12-2022 无菌医疗器械包装试验方法 第12部分：软性屏障材料抗揉搓性

Test methods for sterile medical device packaging-part 12: rubbing resistance of soft barrier materials

22/30450978 DC BS EN 17846 化学消毒剂和防腐剂 用于评估医疗领域使用擦拭巾的机械作用对无孔表面上的艰难梭菌杀孢子活性的定量测试方法……

BS EN 17846. Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of sporicidal activity against Clostridioides difficile on non-porous surfaces with mechanical action employing wipes in the medical area…