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    ASTM F3438-21

    Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
    • 발행일 : 2021-03-01
    • 발행기관 : ASTM
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분야 13.02 : 긴급 의료 서비스; 수색 및 구조
적용범위

1.1?This standard guide provides methods and considerations for detecting and quantifying test soil(s) from reusable medical device(s) that result from simulated-use testing of medical devices during validation of the cleaning procedures as described in the instructions for use (IFU) provided by the medical device manufacturer.

1.2?The methods described are for detecting and measuring markers (analytes) that are components within the most common test soils and are relevant to the clinical use of the device. Appropriate test soils without protein, carbon, or carbohydrates (for example, bone) will require other methods.

1.3?This is a part of a series of ASTM standard guides for validating cleaning instructions. The scope of the first guide in the series is selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods for inoculating medical devices with test soil. The third in the series (Guide F3321) describes methods for extracting soils for measuring residual soil on medical devices after the performance of cleaning process. This is the fourth guide in the series and describes the methods of detecting and quantifying residual analytes on the device.

1.4?Units?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 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.
국제분류(ICS)코드 11.080.01 : 일반 살균 및 소독
11.040.01 : 일반 의료장비
페이지수 7
Edition 21

이력정보

No. 표준번호 표준명 발행일 상태
1 ASTM F3438-24상세보기 Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices 2024-03-15 표준
2 ASTM F3438-24 REDLINE상세보기 Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices 2024-03-15 표준
3 ASTM F3438-21상세보기 Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices 2021-03-01 구판

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