ASTM F3438-24
Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
- Standard No.
- ASTM F3438-24
- Release Date
- 2024
- Published By
- American Society for Testing and Materials (ASTM) US / ASTM
- Latest
- ASTM F3438-24
- Introduction
Interpretation of the core content of the standard
ASTM F3438-24, as the fourth part of the series of guidelines for cleaning validation of medical devices, focuses on standardizing the detection and quantification methods of residual markers (analytes) after cleaning of reusable medical devices. The standard establishes a complete analytical validation system, covering the following key elements:
Comparison of Detection Methods and Technologies
Analyte Type Recommended Detection Method Limit of Detection (LOD) Interference Factors Protein BCA/OPA/Bradford Method 0.5-1.6 µg/cm² Reducing Agent/Surfactant Hemoglobin TMB Method/Copper Phthalocyanine Complex Method 5 µg/mL Oxidant Carbohydrates Phenol-sulfuric acid method 10 µg/mL Strong acid environment Total Organic Carbon (TOC) High-temperature catalytic combustion method 0.05 mg/L Inorganic carbon
Key indicators for method validation
Chapter 6 of the standard clearly requires that the validation of analytical methods must include:
- Linear range: R²≥0.9900, the calibration curve must cover the expected concentration range
- Accuracy: The deviation between the measured value and the theoretical value is ≤15%
- Precision: RSD≤15% (homologous/heterogeneous verification)
- Detection limit/quantification limit: Need to be determined through blank sample statistics
Key points for standard implementation
1. Principles of method selection
According to the recommendations in Chapter 7 of the standard, the following should be considered when selecting a method:
Case: For the verification of detergent residues containing surfactants, the BCA method is more suitable than the Bradford method because it has better tolerance to non-ionic surfactants.
2. Sample Processing Specifications
- The compatibility of the extraction solution with the detection method needs to be verified.
- The sample storage time/container material needs to be verified for stability.
- Special substrates (such as orthopedic instruments) require an adapted extraction method.
Technology Evolution Analysis
Major updates compared to the 2021 version:
- Added a copper phthalocyanine complex hemoglobin detection method, with a 50% increase in sensitivity.
- Clarified the standardized operating procedures for the non-extraction OPA method.
- Strengthened the coordination requirements with ISO 15883-5.
Implementation Recommendations
Validation Scheme Design
- Establish a multi-method complementary validation strategy (e.g., protein detection requires at least two methods with different principles)
- Design worst-case test according to AAMI ST98 requirements
- Introduce standard addition method to improve accuracy of low-concentration samples
Risk Control
Pay special attention to the safety warning in Article 1.5 of the standard:
Example: The phenol-sulfuric acid method must be performed in a fume hood, and the waste liquid must be collected in a dedicated container. It is prohibited to mix with chlorine-containing disinfectants.
ASTM F3438-24 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*， 2026-03-01 Update
- ASTM F3127 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
- 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*， 2025-08-01 Update
- ASTM F3321 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices*， 2026-02-01 Update
- ISO 15883-5 Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
ASTM F3438-24 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
Topics on standards and specifications
Standard and Specification
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