11.080.99 有关消毒和灭菌的其他标准 标准查询与下载

YY/T 0159-2005 压力蒸汽灭菌设备用疏水阀

本标准规定了压力蒸汽灭菌设备用疏水阀(以下简称疏水阀)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。 本标准适用于工作不大于0.4MPa压力蒸汽灭菌设备用疏水阀。

Steam trap fitted on pressure steam sterilizer

YY/T 0157-2005 压力蒸汽灭菌设备用弹簧式放汽阀

本标准规定了压力蒸汽灭菌设备用弹簧式放汽阀(以下简称放汽阀)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放汽阀。

Spring type release on pressure steam sterilizer

ASTM D4196-05 用于确认膜过滤器无菌性的标准试验方法

This test method may be employed to check the sterility of commercially procured sterile membrane filters. The test also confirms that sterilized filters have not been contaminated. Additionally, this test may be used to monitor the efficacy of in-house sterilization procedures. Filter packages that have obvious packaging defects should not be tested because sterility may have been compromised.1.1 This test method describes a test to confirm the sterility of either manufacturer presterilized or user-sterilized analytical membrane filters. 1.2 This standard does not purport to address all of the safety problems, 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 Confirming the Sterility of Membrane Filters

ANSI/AAMI ST81-2004 医疗器件的消毒.由生产商提供的可反复消毒的医疗器件的处理信息

Specifies the information to be be provided by the medical device manufacturer on the processing of a medical device claimed to be resterilizable. This information is required so that the medical device can be adequately processed and will continue to meet its performance specification.

Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices

ASTM E2314-03(2014) 采用微生物方法 (模拟使用试验) 测定可重复使用医疗器械清洁过程有效性的标准试验方法

5.1 This test method is designed to evaluate the effectiveness of cleaning reusable medical instruments using a specified cleaning process. 5.2 This test method may be used to determine the effectiveness of cleaning processes of recesses, hinged sites, lumina, or other difficult-to-reprocess areas of reusable medical instruments. 5.3 This test method may also be used to verify the claims for any portion of the cleaning cycle. 5.4 The recovery of surviving microorganisms may be accomplished using swabbing, rinsing, or total immersion of instruments. 5.5 The efficacy of the elution methods or loss of the applied inoculum may be assessed by recovery of target organisms from control instruments that have not been subjected to the cleaning process. 1.1 This test method is written principally for large medical instruments or instruments with internal channels or recesses (for example, flexible endoscopes) but may be used for any resuable medical instruments. 1.2 This test method describes a procedure for testing the efficacy of a cleaning process for reusable medical instruments artificially contaminated with mixtures of microorganisms and simulated soil. 1.3 The test method utilizes bacterial spores as tracers for foreign materials and quantifies their removal as a means of determining the efficacy of a cleaning process. 1.4 The test method is designed for use by manufacturers of medical instruments and devices. However, it may also be employed by other individuals who have a knowledge of the instruments, techniques and access to appropriate facilities. 1.5 Worst-case conditions can be represented by exaggerating a specific test parameter or otherwise intentionally simulating an extreme condition such as performing the test without cleaning solutions or utilizing instruments which are not new. 1.6 The test procedure is devised to determine the efficacy of a cleaning process as applied to a particular instrument or group of instruments by simulating actual use situations. 1.7 The test procedure may be performed on test instruments using a complete cleaning cycle or be limited to particular phases of the cycle such as precleaning, manual cleaning, automated cleaning, or rinsing. 1.8 The test procedure is normally performed on a number of external and internal sites, but it may be restricted to one particular site on the instrument. 1.9 A knowledge of microbiological and aseptic techniques and familiarity with the instruments is required to conduct these procedures.

Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)

ASTM F1518-00 用于穿孔内脏检查的可弯曲光纤制内窥镜的清洁和消毒标准规程

1.1 This practice covers the flexible fiberoptic and video endoscopes that are fully immersible in liquid and are used in the examination of the hollow viscera (that is, colonoscopes, gastroscopes, duodenoscopes, and sigmoidoscopes). These endoscopes will be referred to as flexible gastrointestinal (GI) endoscopes. 1.2 This practice is intended to complement, not replace the instructions and labeling provided by product manufacturers. Endoscope manufacturers must provide instructions and labeling necessary for users to know the basic design, specifications, nomenclature, and components of specific flexible GI endoscopes and to properly inspect, prepare, use, clean, disinfect, rinse, dry, and store these instruments. 1.3 Endoscopic technique and the medical aspects of gastrointestinal endoscopy are not covered in this practice. 1.4 This practice details the steps necessary to properly reprocess flexible GI endoscopes and render them patient-ready. 1.5 A patient-ready endoscope is one that has been rendered visibly clean after being subjected to a validated cleaning procedure, subjected minimally to a high-level disinfection process, and rinsed so that it does not contain residual reprocessing chemicals in amounts which can be harmful to humans. 1.5.1 It is recognized that in some circumstances, portions of endoscopes that neither contact patients directly nor contact fluids that may contact patients probably do not have to be subjected to high-level disinfection. 1.6 This practice details manual reprocessing as well as automated reprocessing of flexible GI fiberoptic and video endoscopes. 1.7 The application of all practices relating to endoscopic reprocessing will ultimately fall into the purview of the individual assigned to that task in an endoscopic area. 1.7.1 To ensure the proper adherence to this practice, those personnel should themselves meet certain requirements as specified in 4.8. 1.8 This practice does not detail the steps necessary for the reprocessing of endoscopic accessories. 1.9 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. Specific precautionary statements are given in Notes 1 and 2.

Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera

SANS 5002:1987 液体的灭菌

Covers the determination of the sterility of liquids.

Sterility of liquids

SANS 5003:1987 固体物质的灭菌

Covers the determination of the sterility of solid pharmaceutical and surgical materials.

Sterility of solid materials

prEN ISO 11137-1 医疗保健产品灭菌-辐射-第1部分：医疗器械灭菌过程的开发、验证和常规控制要求（ISO/DIS 11137-1:2023）

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)