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ASTM F 3293 : 2018

Current

Current

The latest, up-to-date edition.

Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

05-01-2018

This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions.

1.1This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions. Techniques for application of soil, as well as incorporation of soil by various means (e.g., actuation of devices) will be described in order to assure worst-case contamination of the surface geometry of medical devices.

1.2Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.3This 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.

1.4This 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.

Committee
F 04
DocumentType
Guide
Pages
4
PublisherName
American Society for Testing and Materials
Status
Current

ASTM D 8179 : 2018 Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices

ASTM D 1193 : 1977 : R1983 : EDT 1 Standard Specification for Reagent Water
ASTM F 2809 : 2010 Standard Terminology Relating to Medical and Surgical Materials and Devices (Withdrawn 2019)
ASTM D 1193 : 2006 : R2011 Standard Specification for Reagent Water
ASTM F 3208 : 2017 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
ASHRAE/ASHE 170 : 2013 VENTILATION OF HEALTH CARE FACILITIES
ASTM D 7225 : 2013 : R2019 : EDT 1 Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
ASTM D 1193 : 1991 Standard Specification for Reagent Water
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ASTM F 3208 : 2019 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
ASTM F 3208 : 2018 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
ASTM D 1193 : 1970 Standard Specification For Reagent Water
ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
ASTM D 1193 : 2006 Standard Specification for Reagent Water
ASTM D 1193 : 1999 Standard Specification for Reagent Water
ASTM D 7225 : 2013 Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
ASTM D 1193 : 2006 : R2018 Standard Specification for Reagent Water
ASTM D 7225 : 2006 Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors

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