11.080.99 有关消毒和灭菌的其他标准 标准查询与下载

NF S98-103-1/A1:2013 保健产品的灭菌.辐射.第1部分:医疗器械灭菌过程的制定、确认和常规控制的要求

Sterilization of health care products - Radiation - Part 1: requirements for development, validation and routine control of a sterilization process for medical devices

DIN EN ISO 11137-2:2013 保健产品的灭菌.辐射.第2部分:杀菌剂量的确定(ISO 11137-2-2013).德文版本EN ISO 11137-2-2013

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013

NF S98-103-2:2013 保健产品的灭菌.辐射.第2部分:确定杀菌剂量

Sterilization of health care products - Radiation - Part 2: establishing the sterilization dose

BS EN ISO 11137-2:2013 保健产品的灭菌.辐射.杀菌剂量的确定

Sterilization of health care products. Radiation. Establishing the sterilization dose

EN ISO 11137-2:2013 保健产品的灭菌.辐射.第2部分:确定杀菌剂量

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

ANSI/AAMI/ISO 11137-1AMD 1:2013 保健产品的灭菌.辐射.第1部分:医疗装置消毒的开发、确认和程序控制的要求.修改件1

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1

DIN EN ISO 11137-2:2012 保健产品的灭菌.辐射.第2部分:确定杀菌剂量(ISO 11137-2-2012).德文版本EN ISO 11137-2-2012

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012); German version EN ISO 11137-2:2012

BS EN ISO 11137-2:2012 保健产品的灭菌.辐射.确定杀菌剂量

Sterilization of health care Products. Radiation. Establishing the sterilization dose

DB42/T 802-2012 可重复使用医用织物洗涤消毒技术规范

Technical specifications for washing and disinfection of reusable medical fabrics

GOST ISO 11137-1-2011 保健产品的灭菌.辐射.第1部分:医疗器件消毒过程的制定、确认和常规控制的要求

Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices

YY 0791-2010 医用蒸汽发生器

本标准规定了医用蒸汽发生器的术语和定义、型式与组成、要求、试验方法、检验规则、标志与使用说明书以及包装、运输、贮存。 本标准适用于额定输出蒸汽工作压力不大于0.8MPa，采用电加热产生蒸汽的医用蒸汽发生器（以下简称蒸汽发生器），该蒸汽发生器产生的蒸汽供医用设备(如灭菌设备、清洗消毒设备等)使用。 本标准不适用于其他方式产生蒸汽的蒸汽发生器。

Steam generators for medical use

ASTM E2720-10 当表层沾有人体病原性病毒时用于评估透气材料净化程序效能的标准试验方法

The efficacy of disinfection technologies can be evaluated on finished products, as well as on developmental items. This test method defines procedures for validation of the aerosol generator, preparation of the test specimen, application of the challenge virus, enumeration of viable viruses, assessing data quality, and calculation of decontamination efficacy. This test method provides defined procedures for creating droplet nuclei that approximate those produced by human respiratory secretions with particular emphasis on particle size distribution and aerosolization media. Safety concerns associated with aerosolizing microbial agents are not addressed as part of this test method. Individual users should consult with their local safety authority, and a detailed biological aerosol safety plan and risk assessment should be conducted prior to using this method. Users are encouraged to consult the manual Biosafety in Microbiological and Biomedical Laboratories published by the U.S. Centers for Disease Control and Prevention (CDC). This test method differs from Test Methods E1052 and E2197 in the presentation of the virus to surface. The aforementioned test methods use liquid inoculum to contaminate carrier surfaces, whereas this test method presents the virus in the absence of water as droplet nuclei. This test method differs from Test Method because (1) smaller particles are being formed, (2) the droplets will be dried, thus forming droplet nuclei, prior to application to air-permeable materials, and (3) unique equipment is required to create the droplet nuclei.1.1 This test method is designed to evaluate decontamination methods (physical, chemical, self-decontaminating materials) when used on air-permeable materials contaminated with virus-containing droplet nuclei. 1.2 This test method defines the conditions for simulating respiratory droplet nuclei produced by humans. 1.3 The method is specific to influenza viruses but could be adapted for work with other types of respiratory viruses or surrogates (Appendix X6). 1.4 This test method is suitable only for air-permeable materials. 1.5 This test method does not address the performance of decontaminants against microbes expelled via blood splatter, vomit, or fecal contamination. 1.6 This test method should be performed only by those trained in bioaerosols, microbiology, or virology, or combinations thereof. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 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 Test Method for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses

ASTM E2721-10 评定遭到含有人类致病性病毒的飞沫攻击时表面净化程序效能的标准试验方法

The efficacy of disinfection technologies can be evaluated on finished products, as well as on developmental items. This test method defines procedures for validation of the droplet generator, preparation of the test specimen, application of the challenge virus, enumeration of viable viruses, assessing data quality, and calculation of decontamination efficiency. This test method provides defined procedures for creating droplets that approximate those produced by human respiratory secretions, with particular emphasis on droplet size distribution and aerosolization media. Safety concerns associated with aerosolizing microbial agents are not addressed as part of this test method. Individual users should consult with their local safety authority, and a detailed biological aerosol safety plan and risk assessment should be conducted prior to using this method. Users are encouraged to consult the manual Biosafety in Microbiological and Biomedical Laboratories published by the U.S. Centers for Disease Control and Prevention (CDC). This test method differs from Test Methods E1052 and E2197 in the presentation of virus to the surface. The aforementioned test methods use liquid inoculum to contaminate carrier surfaces, whereas this method presents the virus in droplets that are representative of human respiratory secretions This method differs from Test Method , because (1) larger droplets are being formed, (2) the droplets will not be completely dried prior to application to surfaces, (3) the droplets can be applied to any surfaces, not just those that are air permeable, and (4) unique equipment is required to create droplets.1.1 This test method is designed to evaluate decontamination methods (physical, chemical, self-decontaminating materials) when used on surfaces contaminated with virus-containing droplets. 1.2 This test method defines the conditions for simulating respiratory droplets produced by humans and depositing the droplets onto surfaces. 1.3 The method is specific to influenza viruses but could be adapted for work with other types of respiratory viruses or surrogates (Appendix X5). 1.4 This test method is suitable for working with a wide variety of environmental surfaces. 1.5 This test method does not address the performance of decontaminants against microbes expelled via blood splatter, vomit, or fecal contamination. 1.6 This test method should be performed only by those trained in bioaerosols, microbiology, or virology, or combinations thereof. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 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 Test Method for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses

YY/T 0084.1-2009 圆形压力蒸汽灭菌器主要受压元件强度计算及其有关规定

YY/T 0084的本部分规定了单层、双层圆形压力蒸汽灭菌器主要受压元件强度计算及其有关规定，对于本部分未予规定的则由相应的标准规定。 本部分适用于设计压力不大于0.4MPa的圆形压力蒸汽灭菌器。也适用于承载负压的圆形压力蒸汽灭菌器。

Strength calculation and relevant regulations of primary pressure components of cylindrical pressure steam sterilizer

YY/T 0084.2-2009 矩形压力蒸汽灭菌器主要受压元件强度计算及其有关规定

YY/T 0084的本部分规定了带夹套的矩形压力蒸汽灭菌器主要受压元件的强度计算及其有关规定，对于本部分未予规定的则由相应的标准规定。 本部分适用于设计压力不大于0.4MPa，灭菌室容积不大于6m，灭菌室截面积不大于1.2m的下排气式或预真空式压力蒸汽灭菌器。

Strength calculation and relevant regulations of primary pressure containing parts for rectangular pressure steam-heated sterilizer

DIN EN ISO 11137-2:2007 保健产品的灭菌.辐射.第2部分:确定杀菌剂量(ISO 11137-2:2006, corrected version 2006-08-01)

This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. This part of ISO 11137 also specifies methods of dose auditing to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for dose establishment and dose auditing.

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); English version of DIN EN ISO 11137-2:2007-09

BS EN ISO 11137-1:2006+A1:2013 医疗保健产品的消毒. 辐射. 医疗器械消毒方法的制定, 确认和常规控制要求

Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices

ANSI/AAMI/ISO 11138-2:2006 医疗保健产品灭菌.生物指示器.第2部分:环氧乙烷灭菌处理用生物指示器

Provides specific requirements for test organisms and biological indicators intended for use in assessing the performance of sterilizers employing pure ethylene oxide gas or admixtures of the gas with diluent gases at sterilizing temperatures within the range of 20 degrees C to 65 degrees C.

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

YY 0154-2005 压力蒸汽灭菌设备用弹簧式安全阀

本标准规定了压力蒸汽灭菌设备用弹簧式安全阀(以下简称安全阀)的分类与标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、贮存。 本标准适用于压力蒸汽灭菌设备用弹簧式安全阀。

Spring type safety valve on pressure steam sterilizer

YY/T 0158-2005 压力蒸汽灭菌设备用密封垫圈

本标准规定了压力蒸汽灭菌设备用密封垫圈(以下简称密封垫圈)的分类与标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、贮存。 本标准适用于压力蒸汽灭菌设备用密封垫圈。

Spring type gasket on pressure steam sterilizer