ASTM F3208-2020 Testing Laboratory

Reusable medical devices, such as endoscopes, arthroscopes, surgical instruments, etc., are exposed to contamination during clinical use from a mixture of common components found in human secretions, blood, tissues, bone fragments/debris, and non-patient sources (e.g., bone cement and lubricants). When designing cleaning validation tests, the selection and determination of test contaminants should be based on the intended clinical use of the medical device and should also simulate the physical parameters of clinical materials that the device will come into contact with, such as viscosity and adhesion.

ASTM F3208-2020 "Standard Guide for the Selection of Test Contaminants for Validation of Cleaning Methods for Reusable Medical Devices" provides formulations, preparation methods, and applicable cleaning markers based on the physical properties of contaminants generated during clinical use of devices. Below are some commonly used test contaminants:

1. Blood Contaminant

Composition:

- 100 mL Citrated whole sheep blood

- 50 mL Bovine serum

- 50 mL Physiological saline solution (PHSS, 0.9% NaCl)

- 0.01 mL 2M CaCl2 solution

Preparation:

Mix whole blood with serum and physiological saline solution. Add 0.01 mL of 2M CaCl2 immediately before use to activate coagulation.

Cleaning Markers:

- Protein

- Hemoglobin

- TOC

- Carbohydrates

- Coagulation

2. Coagulated Blood Contaminant

Composition:

- 100 mL sheep blood (heparinized)

- 0.1 mL heparin per 100 mL sheep blood

- 0.15 mL protamine sulfate per 10 mL blood

Preparation:

Allow sheep blood to coagulate at room temperature, then add heparinized sheep blood into a bowl and mix with protamine sulfate. The blood should coagulate within 10–15 minutes.

Cleaning Markers:

- Protein

- Hemoglobin

- TOC

- Carbohydrates

3. Artificial Test Contaminant (ATS)

Composition:

- 10.4 g RPMI 1640 culture medium

- 100 mL heat-inactivated bovine serum

- 20 g bovine bile (optional)

- 20% defibrinated sheep blood (final volume)

- 2 g sodium bicarbonate

- 10 mL sodium pyruvate (100 mM)

- 10 mL L-glutamine (200 mM)

- Distilled water to make 1 L

Preparation:

Mix the ingredients, filter the solution through a 0.22 μm filter into a sterile container, and then add sterile sheep blood and heat-inactivated bovine serum.

Cleaning Markers:

- Protein

- Hemoglobin

- TOC

- Carbohydrates

- Lipids

4. Bone Contaminant

Composition:

- Same as ATS above, plus:

- 0.005 g bone particles per 1 mL of ATS contaminant

Preparation:

Follow the same procedure as ATS, adding bone particles to the contaminant. Freeze-dried contaminants are available for purchase.

Cleaning Markers:

- Protein

- Hemoglobin

- TOC

- Carbohydrates

- Lipids

- Defibrinated

5. Defibrinated Blood Contaminant

Composition:

- 100 mL fresh egg yolk

- 100 mL defibrinated sheep blood

- 2 g dehydrated pig mucin

Preparation:

Mix all components using a stirrer.

Cleaning Markers:

- Protein

- Hemoglobin

- TOC

- Carbohydrates

6. Simulated Ocular Test Contaminant

Composition:

- 0.8 g dried egg yolk

- 10 mL defibrinated horse or sheep blood

- 1 g dehydrated pig mucin

Preparation:

Mix components into a liquid.

Cleaning Markers:

- Protein

- Hemoglobin

- TOC

- Carbohydrates

7. Oral Test Contaminant

Composition:

- 0.7057 g Hemoglobin

- 0.5463 g Albumin

- 0.0019 g Sodium alginate

- 0.1 g Bone powder

- 0.04 g Mucin

- 3.395 mL sterile water

- 0.105 mL 1 M CaCl2

- 3.5 mL artificial saliva

Preparation:

Weigh dry components into a 10 mL vial. Under a laminar flow hood or biological safety cabinet, transfer the liquid components into another vial. Mix the dry and wet components before use and vortex to mix.

Cleaning Markers:

- Protein

- Hemoglobin

- TOC

- Carbohydrates

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