Glossary Term
ISO 11137 (Radiation Sterilization Validation)
Definition
ISO 11137 is an international standard that specifies requirements for the development, validation, and routine control of sterilization processes using ionizing radiation, including gamma rays, electron beams (e-beam), and X-rays. The standard ensures that medical devices achieve a Sterility Assurance Level (SAL) of 10⁻⁶, meaning there is less than a one-in-a-million chance of a viable microorganism remaining after sterilization.
Relevance to the MedTech Industry
ISO 11137 provides a structured framework to ensure the safety and sterility of medical devices that undergo radiation sterilization. This standard is crucial for maintaining patient safety, regulatory compliance, and the integrity of medical devices during their intended use. It is particularly important for devices that cannot tolerate high temperatures or chemical sterilization methods.
Additional Information & Related Terms
Examples of Applications
Surgical Instruments: Single-use devices like scalpels and forceps are sterilized using gamma or e-beam radiation.
Implantable Devices: Orthopedic implants, cardiac stents, and catheters benefit from radiation sterilization due to its effectiveness at low temperatures.
Wound Care Products: Dressings and bandages are sterilized without compromising their material properties.
Diagnostic Kits: Single-use plastics in diagnostic kits are sterilized for safe patient use.
Related Terms
Sterility Assurance Level (SAL): The probability of a non-sterile unit after sterilization, typically set at 10⁻⁶ for medical devices.
Bioburden Testing: Measures the microbial load on a device before sterilization to determine the required dose.
Gamma Sterilization: A common radiation sterilization technique using gamma rays from isotopes like Cobalt-60.
Electron Beam Sterilization (E-Beam): A faster alternative to gamma sterilization, suitable for low-density products.