11.080.20 消毒剂和防腐剂 标准查询与下载

BS EN 13624:2003 化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验.试验方法和要求(第2阶段第1步)

This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal 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. Products can only be tested at a concentration of 80% or less as some dilution is always produced by adding the test organisms and interfering substance. This European 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 European 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 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. 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 E).

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)

AWWA C653-2003 水处理设备消毒

This standard describes chlorination materials, procedures, and requirements for disinfection of new treatment facilities and existing water treatment facilities temporarily taken out of service for cleaning, inspection, maintenance, painting, repair,

Disinfection of Water Treatment Plants

DB37/T 378-2003 针织布口罩

本标准规定了二氯异氰尿酸钠的要求、试验方法、检验规则及标志、使用说明书、包装、运输和贮运

knitted cloth mask

DB37/T 375-2003 过氧乙酸含量测定方法

本标准规定了复配次氯酸钠消毒液的技术要求、试验方法、检验规则及包装、标志、运输、储存的要求

Determination method of peracetic acid content

EN ISO 15882:2003 保健产品的消毒.化学指示剂.选择,使用指南和效果说明 ISO 15882-2003

Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results ISO 15882:2003

ISO 15882:2003 保健产品的消毒.化学指示剂.选择、使用指南和效果说明

This International Standard provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation, and routine monitoring and control of sterilization processes. This International Standard is applicable to chemical indicators for which International Standards exist (see ISO 11140 series). This International Standard is not applicable to those processes that rely on physical removal of microorganisms, e.g. filtration. This International Standard is not intended to apply to combination processes, for example, washer-disinfectors or flushing and steaming of pipelines.

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results

EN 13624:2003 化学消毒剂与防腐剂.医疗器械用化学消毒剂杀真菌能力评价用定量悬浮液试验的试验方法和要求(第2阶段第1步骤)

This European Standard specifies a test method andThe minimum requirements for fungicidal or yeasticidalactivity of chemical disinfectant products that form a homogeneous, physically stable preparation when dilutedwith hard water or一inThe case of ready-to-use products一with water. Products can only be tested at aconcentration of 80%or less as some dilution is always produced by addingThe test organisms andinterfering substance.This European Standard applies to products that are used inThe medical area for disinfecting instruments byimmersion一even ifThey are not covered byThe EEC/93/42 Directive on Medical Devices.This European Standard applies to areas and situations where disinfection is medically indicated. Suchindications 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 inThe workplace and inThe home. It may also include services such as laundries and kitchenssupplying products directly forThe patients.NOTE 1 The method described is intended to determineThe activity of commercial formulations or active substancesunderThe conditions in whichThey are used.NO丁E2This method corresponds to a phase 2 step 1 test (see annex E)

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)

AWWA C652-2002 水存储设备消毒

This standard describes grooved and shouldered joints for ductile-iron pipe, metallic pressure pipe of iron pipe size, and fittings, and other components for water service.

Disinfection of Water-Storage Facilities

BS EN 867-5:2001 消毒器用非生物系统.B类和S类小型消毒器的性能试验时使用的指示剂系统和处理设备规范

This European Standard specifies the performance requirements and test methods for non-biological indicator systems, including the process challenge devices within which they are intended to function, to be used for testing the steam penetration performance of small steam sterilizers, Type B or Type S where appropriate. The test systems specified are intended for use only in small steam sterilizers Type B conforming to prEN 13060-2 and having a usable chamber space greater than 10I and for small steam sterilizers Type S conforming to prEN 13060-4 also having a usable chamber space greater than 5I. Non-biological indicator systems and the associate process challenge devices are specified for various types of load. The possible loads are considered in two classes: Porous loads, which can be wrapped or unwrapped, or hollow instrument loads, which also can be wrapped or unwrapped. The relevant section of this European Standard on porous loads specifies the requirements for: - a standard process challenge device to be used in the small load test for porous loads in small steam sterilizers; - an indicator system for use in the porous load process challenge device. An indicator for this purpose is a Class B indicator as described in EN 867-1. - an indicator employing an alternative process challenge device equivalent to the porous load process challenge device. The relevant section of this European Standard on hollow instruments specifies the requirements for: - hollow load process challenge devices to be used to simulate hollow instrument loads as defined in prEN 13060-4; - an indicator system, for use in one of the hollow load process challenge device, for assessing steam penetration in a wrapped load of hollow instruments. An indicator for this purpose is a Class B indicator as described in EN 867-1. The process challenge devices described in this standard are intended for use only in sterilizers of sufficient size to accommodate the process challenge device with no part of the process challenge device closer than 20 mm from the vessel wall; in the case of the porous load process challenge device the total internal volume of the vessel is not less than 10I

Non-biological systems for use in sterilizers - Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S

ISO 11140-4:2001 保健品灭菌化学指示剂 第4部分：蒸汽渗透测试包的2类指示剂

This part of ISO 11140 specifies the performance requirements for a Class 2 indicator to be used as an alternative to the Bowie and Dick test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads). An indicator complying with this part of ISO 11140 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This part of ISO 11140 does not specify requirements for the test load, but specifies the performance of the indicator system in combination with the test load with which it is intended to be used: The indicator specified in this part of ISO 11140 is intended to identify poor steam penetration but does not in-dicate necessarily the cause of this poor steam penetration. This part of ISO 11140 does not include test methods to establish the suitability of these indicators for use in steriliz-ers in which the air removal stage does not include evacuation below atmospheric pressure. NOTE The Bowie and Dick Test is performed to demonstrate conformance of a steam sterilizer for wrapped health care goods to EN 285 and may be used as a routine test of performance of such a sterilizer (see ISO 11134). The test procedure is described in EN 285.

Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators for steam penetration test packs

BS EN 867-4:2001 消毒器用非生物系统.蒸汽渗透性检测用Bowie和Dick试验的替换用指示器的规范

This European Standard specifies the performance requirements for a Class B indicator to be used as an alternative to the Bowie and Dick test for steam sterilizers for wrapped goods (instruments, etc. and porous loads). An indicator complying with this European Standard incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This European standard does not specify requirements for the test load but specifies the performance of the indicator system in combination with the test load with which it is intended to be used. The indicator specified in this European standard is intended to identify poor steam penetration but does not indicate necessarily the cause of this poor steam penetration. The Bowie and Dick test is performed to demonstrate conformity of a steam sterilizer for wrapped goods to EN 285 and may be used as a routine test of performance of such a sterilizer (see EN 554). The method of carrying out the test is described in EN 285. This European Standard 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.

Non-biological systems for use in sterilizers - Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration

GOST R ISO 11140-2-2001 健康医疗产品消毒.化学指示剂.第2部分:测试设备和方法

Настоящий стандарт устанавливает требования к оборудованию и методам испытаний, применяемым для проверки химических индикаторов. Станда

Sterilization of health care products. Chemical indicators. Part 2. Test equipment and methods

ISO 11140-5:2000 医疗保健产品灭菌 化学指示物 第5部分:二级指示物 排气试验纸和试验包

This part of ISO 11140 specifies the requirements for an indicator and alternative test system 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 require-ments.

Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for air removal test sheets and packs

ISO 14161:2000 医疗保健产品灭菌 生物指示物 选择、使用和检验结果解释指南

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. NOTE 1 See for example the ISO 11138 series. NOTE 2 The general information provided in this International Standard may have useful application for processes and biological indicators not currently addressed by existing International Standards, e.g. new and developing sterilization processes. This International Standard does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration. This International Standard is not intended to apply to combination processes, using for example washer disinfectors or flushing and steaming of pipelines. This International Standard is not intended to apply to liquid sterilization processes.

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results

ISO 11140-3:2000 医疗保健产品灭菌 化学指示物 第3部分:二级指示物 蒸气穿透试验纸

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 detail requirements for the standard test pack, but specifies the performance of the indicators.

Sterilization of health care products - Chemical indicators- Part 3: Class 2 indicators for steam penetration test sheets

SANS 288:2000 医用抗菌液体盥洗皂

Covers two types of anti-bacterial liquid toilet soap for medical use and that are suitable for use in liquid soap dispensers.

Anti-bacterial liquid toilet soap for medical use

EN ISO 14161:2000 医疗保健产品灭菌.生物指示物.选择,使用和检验结果解释指南 ISO 14161-2000

Sterilization of Health Care Products - Biological Indicators - Guidance for the Selection, Use and Interpretation of Results ISO 14161:2000

VC 8054-1999 消毒剂和洗涤消毒剂

Covers requirements for disinfectants and detergent-disinfectants intended for use on inanimate surfaces.

Disinfectants and detergent-disinfectants

ASTM E2011-99 评价全部用手工消除病毒活性的人工洗涤方法的标准试验方法

This test method should be used to evaluate the virus-eliminating effectiveness of these formulations after handwashing. Effective formulations can be further evaluated in a clinical trial on human subjects. Published data have shown (1) that results of in vitro tests do not accurately reflect what occurs when this class of products is used in the health care facility. This test method involves the incorporation of whole hand exposure and friction from washing, reflecting actual use conditions in human subjects. It is meant to confirm the results of testing with Test Method E 1836. This method gives precise reductions on a limited area of the finger, the fingerpads. This test method is not meant for use with surgical hand scrubs or preoperative skin preparations.1.1 This test method is designed to evaluate antimicrobial agents in formulations for utility and effectiveness for virus-eliminating activity using human subjects. 1.2 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. The user should consult a reference for laboratory safety recommendations. (2, 3)

Standard Test Method for Evaluation of Handwashing Formulations for Virus-Eliminating Activity Using the Entire Hand

NF S98-112:1998 用液体化学消毒剂进行消毒的确认和常规控制方法.一次性使用的含动物本原材料的医疗用器材的消毒

Validation and routine control of sterilization by liquid chemical sterilants. Sterilization of single-use medical devices incorporating materials of animal origin.