1. What is Cleaning, Disinfection, and Sterilization Validation?

Cleaning, disinfection, and sterilization validation involves using scientific methods and strict experimental procedures to ensure that medical devices meet established safety and efficacy standards after undergoing cleaning, disinfection, and sterilization processes. This process is crucial for the safe reuse of medical devices, as used devices may be contaminated with organic substances such as blood and bodily fluids and could potentially become breeding grounds for microbes. Incomplete cleaning, disinfection, and sterilization can leave residual microbes that may cause infections in patients. Therefore, rigorous validation of these processes is a key measure to ensure that medical devices can be safely reused.

Cleaning is the removal of contaminants from products using detergents according to a specific procedure, reducing the initial contamination before disinfection or sterilization to ensure the effectiveness of the final sterilization or disinfection.

Disinfection is the process of killing or removing microbes on medical devices to a level that does not cause disease.

Sterilization is the process or technique of killing or removing all life forms from materials or equipment using physical or chemical methods, achieving a state where no viable microbes are present.

2. Domestic and International Requirements

• In 2015, the U.S. FDA published guidelines for the instructions for use and labeling of reusable medical devices.
• In 2019, China released a draft for public consultation of the reprocessing instructions and confirmation method registration technical review guidelines for reusable medical devices.
• In 2020, the European Commission issued guidelines for the instructions for reusable and repeatedly sterilized medical devices.

3. Testing Standards

Cleaning, Disinfection, and Sterilization Validation Services:

CIRS Testing is dedicated to providing cleaning, disinfection, and sterilization validation services for medical devices, ensuring their safety and reliability in clinical applications. Our validation process follows strict scientific methodologies and experimental procedures to ensure that medical devices meet relevant safety standards after undergoing cleaning, disinfection, and sterilization.

CIRS Testing, your professional partner for medical device cleaning, disinfection, and sterilization validation, offers scientific and systematic solutions to ensure every device serves clinical needs safely and efficiently.

Our Advantages

Whole Industry Chain Services｜Provide full industry chain technical services, including R&D support, safety evaluation and testing, registration, clinical, quality management system, etc.

Professional Technical Team | A team of experts in the fields of medical device regulations, registration, medicine, toxicology, statistics, biological evaluation, chemical analysis, microorganisms, etc., with comprehensive technical service capabilities

Professional Laboratory｜Own several professional laboratories, including chemical analysis lab, materials lab, microorganisms lab, environment lab, efficacy evaluation lab, animal safety evaluation lab, etc.

Rich Industry Experience｜Successful cases on safety assessment, registration and clinical services in active, non- active and IVD; Rich experience in implantable degradable products, medical beauty products, oral materials, cavity stents, assisted reproductive products and orthopedic ophthalmology field.

If you have any needs or questions, please contact us at test@cirs-group.com.