ASTM F3438-21
Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
- Standard No.
- ASTM F3438-21
- Release Date
- 2021
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F3438-24
- Latest
- ASTM F3438-24
- Scope
- 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
ASTM F3438-21 Referenced Document
- ASTM D7573 Standard Test Method for Total Carbon and Organic Carbon in Water by High Temperature Catalytic Combustion and Infrared Detection
- ASTM E1097 Standard Guide for Direct Current Plasma Emission Spectrometry Analysis
- ASTM E2520 Standard Practice for Measuring and Scoring Performance of Trace Explosive Chemical Detectors*， 2024-04-21 Update
- ASTM F3127 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices*， 2022-10-01 Update
- ASTM F3208 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
- ASTM F3293 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
- ASTM F3321 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
- ISO/TS 15883-5 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy
ASTM F3438-21 history
- 2024 ASTM F3438-24 Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
- 2021 ASTM F3438-21 Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
