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ISO 11737 Bioburden Test
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Quick understanding of the test
Applicable to all health care products requiring terminal sterilization, including medical devices, pharmaceutical packaging materials, and raw materials in cleanroom production environments.
This standard does not specify a fixed list of microbes but typically includes:
- Bacteria: Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis
- Fungi: Candida albicans, Aspergillus brasiliensis
- Environmental Contaminants: Any naturally occurring microbes found on the product.
The bioburden test involves:
- Sampling
- Recovery & Cultivation
- Enumeration
- Characterization
- Essential for sterilization validation and also detects contamination during manufacturing processes.
- Improves product safety and reduces the risk of microbial contamination.
Turnaround Time
Typically 2โ3 weeks.
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Abstract
ISO 11737 is an international standard used to define the requirements and procedures for establishing the population of living microorganisms (bioburden) on medical devices, components, raw materials, or packaging prior to sterilization. The determination is of primary importance in the validation and control of sterilization processes in order to provide assurance of product safety and conformance with regulatory requirements.
ISO 11737 consists of two parts:
- ISO 11737-1: Focuses on determining the number of microorganisms present on a product.
- ISO 11737-2: Addresses the sterility assurance level and the determination of viable microorganisms following sterilization.
Scope of Application
ISO 11737-1 applies to health care products and medical devices intended for terminal sterilization and includes:
- Finished medical devices
- Raw materials and packaging components
- Products under manufacturing for microbiological quality control.
This standard is not applicable to the enumeration of viruses, prions, or protozoa and excludes environmental monitoring.
Test Conditions & Requirements
- Mandatory test microorganisms โ No fixed strains, detects viable aerobic bacteria, yeasts, and molds present on the product
- Sample selection โ Entire product or representative portion (Sample Item Portion, SIP)
- Neutralization โ Required if product contains inhibitory substances
- Incubation conditions โ Based on expected microbial species and product nature
- Pass/fail limits โ Determined by product-specific risk assessments
- Reporting units โ CFU/item or CFU/SIP
Test Method
- Sampling: Microorganisms are collected from the product by using rinsing, swabbing, or direct contact methods.
- Recovery & Cultivation: Microbes are extracted and incubated on appropriate growth media.
- Enumeration: Colony-forming units (CFUs) are counted to determine the microbial load.
- Characterization: Microbial species are identified when necessary.
Importance
ISO 11737 bioburden testing is a crucial microbiological assessment conducted to validate the effectiveness of sterilization processes used in the production of medical devices and healthcare products. This test method also plays a pivotal role in monitoring and controlling manufacturing processes by providing a quantifiable measure of the viable microorganisms present on or within a product before sterilization. By determining the microbial load, manufacturers can verify that their processes are consistently within acceptable limits and can take corrective actions if needed to ensure product safety. Moreover, ISO 11737 testing ensures compliance with international safety standards and performance requirements, thus safeguarding patients and end-users from potential risks associated with microbial contamination.
ISO 11737 testing ensures compliance with international safety standards and performance requirements, thus safeguarding patients and end-users from potential risks associated with microbial contamination.
At Microbe Investigations Switzerland (MIS), we provide ISO 11737 compliant bioburden testing services tailored to meet regulatory and product-specific needs. Our expert team delivers rapid, reliable results using validated methodologies and industry-leading practices.
For more information or to request ISO 11737 testing, contact our experts here.
Frequently Asked Questions
DR. Martinoz Scholtz
ISO 11737 stipulates requirements and guidance for determining and characterizing viable microorganisms (bioburden) on healthcare products and packaging before sterilization.
The ISO 11737 is applicable to healthcare products, components, raw materials, and packaging materials.
The standard does not specify a turnaround time for testing, as it depends on the product type and laboratory procedures.
The ISO 11737 standard does not specify the exact number of bacteria or viruses to be tested; it focuses on the enumeration of viable microorganisms present on or in a product.
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