Sterilization Validation Services (SVS)
Sterilization Validation Services Sterilization Validation Services (SVS) provides contract sterilization services to its clients, through its capacity as a division of Life Science Outsourcing Inc. Contact Us Request a Quote years of package testing expertise 0 + devices validated across EtO, radiation, and steam 0 + regulatory submissions supported (FDA, EU MDR) 0 + ISO […]
ISO 17665 – Steam Sterilization
ISO 17665:2024 Moist Heat (Steam) Sterilization for Medical Devices Overview What Changed Scope Requirements LSO Services FAQs Last updated: March 2025 (ISO 17665:2024) ISO 17665:2024 defines how to develop, validate, and routinely control moist heat (steam) sterilization processes for medical devices. The standard helps you justify your autoclave cycle scientifically, validate it, and keep it […]
Medical Device Testing
Ensure your medical devices meet global safety and compliance standards with Life Science Outsourcing’s expert validation testing services, including Bioburden, Sterility, and Cytotoxicity testing.
Bioburden Testing for Medical Devices
Bioburden testing is one method of many used in medical device sterilization testing processes. Learn more about this important method, who needs it, and how it works.
Product Sterility Testing for Medical Devices
Product Sterility Testing for Medical Devices LSO What is product sterility testing? Sterility testing is used during validation to detect the presence of viable microorganisms that may remain in or on a medical device after undergoing a sublethal sterilization process. This type of testing is necessary to determine if the fully sterilized device will be […]
Microbial Identification Testing for Sterilized Medical Devices
Microbial Identification Testing for Sterilized Medical Devices LSO What is microbial identification testing? During sterilization validation and routine monitoring, microbial identification testing occurs to characterize natural product bioburden. Identification can also be performed after the sterilization process to investigate biological indicator sterility failures. The test can include various methods, including biochemical tests, molecular techniques, and […]
EO Residual Testing for Medical Devices
EO Residual Testing for Medical Devices LSO What is an EtO/EO residual test? An EO residual test measures the amount of ethylene oxide (EO) and ethylene chlorohydrin (ECH) that may be remaining on a medical device after it has been sterilized. EO is a common sterilization agent used to sterilize medical devices, especially those that […]
Cytotoxicity Testing for Medical Devices
Cytotoxicity testing is one method of many used in medical device sterilization testing processes. Learn more about this important method, who needs it, and how it works.
Bacterial Endotoxin Testing
Bacterial endotoxin testing (BET) is one method of many used in medical device testing processes. Learn more about this important method, who needs it, and how it works.
Medical Device Sterilization Validation
Medical Device Sterilization Validation LSO Life Science Outsourcing (LSO) provides medical device sterilization validation engineering and testing services in FDA-registered, ISO 13485-certified facilities. Services include validation of ethylene oxide (EO), radiation (gamma and eBeam), and steam sterilization processes in accordance with FDA regulations and ISO standards. What Services Does LSO Provide for Medical Device Sterilization […]