ISO 11737-2 Sterility Testing

TEST METHOD

ISO 11737-2 ISO 11737-2

Sterility testing for medical device sterilization validation

ISO 11737-2 specifies requirements for sterility tests performed during the validation, definition, and maintenance of sterilization processes for medical devices. The test evaluates the effectiveness of sterilization processes by assessing microbial recovery after exposure to sublethal sterilization conditions. This standard is not intended for routine sterility release testing or product shelf-life evaluation.

The diagram below summarizes the ISO 11737-2 test method.

TESTING CRITERIA AND CUSTOMER PROCESS

Step 1: How is the sample prepared?

The product or a representative Sample Item Portion (SIP) is prepared for testing using a validated method appropriate for the product type.

Step 2: How is sterility evaluated?

The method used for sterility testing depends on the product characteristics and how microorganisms can be recovered from the product.

Direct immersion: The product or Sample Item Portion (SIP) is placed directly into sterile culture medium and incubated. This is the preferred method whenever practicable, as it allows the culture medium to come into contact with the product.
Removal of microorganisms: When direct immersion is not practical, for example due to the size or characteristics of the product, microorganisms are removed from the product using an appropriate method. The recovered microorganisms are then transferred to culture medium for incubation.
Filtration: For liquid products, the product can be passed through a membrane filter. The filter is then placed in sterile culture medium and incubated.

The selected method should be suitable for the product and allow effective recovery and detection of microorganisms.

Step 3: What are the incubation conditions?

The culture media are incubated under specified temperature and time conditions to support the growth and recovery of viable microorganisms.

Bacteria: Incubated at 30–35°C for 3 days using Tryptic Soy Agar (TSA).
Yeasts and moulds: Incubated at 20–25°C for 5 days using Sabouraud Dextrose Agar (SDA).

Step 4: How are the results interpreted?

Following incubation, the test media are examined for evidence of microbial growth to determine whether viable microorganisms are present.

Step 5: What are the acceptance criteria?

For sterilization process validation, the test passes when no evidence of microbial growth is observed under the specified test conditions.

Step 6: Place an order and send your sample to us

Fill in the test request form and place an order via email at info@tecolab-global.com. We will advise on the quantity of sample required for testing.

You can deliver the sample to us via courier or our sample delivery service and provide us the tracking code. We will monitor the delivery status and inform you when we receive the sample.

Step 7: Track the status of your request

Once we have received your sample, we will provide a tracking number to you. You can easily track the status of your request here.

Step 8: Download your password-protected test report

Download your readily available test report online with just a single click using the link and password provided via email notification. We will receive a notification once you have downloaded the test report.

For safety purposes, the uploaded test report will self-destruct after 7 days.