reusable medical devices should be user-friendly and convenient for efficient cleaning and necessary disinfection or sterilization. manufacturers of medical devices should adequately specify information on cleaning, disinfection, or sterilization. at the same time, the manufacturer should keep the verification records of the relevant reprocessing information according to the requirements of the good manufacturing practice for medical devices, to prove that the reprocessing information has been verified and is easy for users to understand and operable.
cleaning, disinfection and sterilization validation service
- iso17664--cleaning verification
- iso17665-1-moist heat sterilization verification
- iso17664/17665-disinfection verification
- aamitir12 - designing, testing, and labeling reusable medical devices: a guide for medical device manufacturers
- low-temperature hydrogen peroxide plasma sterilization verification
- enterprise standard - clean, disinfection or sterilization verification
basis of testing method:
cleaning validation | iso 17664 |
moist heat sterilization verification | iso 17665-1, gb 18278.1 |
service process
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.
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