Medical Device
Partner with Accuratus to Validate Your Reusable Medical Device Reprocessing Procedures
Accuratus Lab Services performs reusable medical device reprocessing validations by partnering with our customers to develop and validate an effective procedure. Manufacturers of reusable medical devices must provide validated instructions to reprocess their products to comply with regulations and to ensure they can be reprocessed in the healthcare setting (AAMI TIR 30). We work with… Read More
Categories: News
Tags: Medical Device
AAMI ST77 Reusable Device Studies
AAMI ST77 Reusable Device Studies Microtest offers exceptional testing of medical devices manufactured for reuse in clinical settings. Tests include: High/low-level disinfection Cleaning studies Steam/EO/chemical sterilization Our AAMI ST77 reusable device studies are ideal to support initial U.S. FDA Section 510(k) submissions on new products or for use after a relevant change to an existing… Read More
Categories: Medical Device
Tags: AAMI, Medical Device, Reusable Device, Study, and Test
Re-Use Stress Testing and Evaluation of Disinfectants
Purpose of Test The U.S. FDA and Health Canada require that high-level disinfectants intended to be continuously reused in a clinical setting be evaluated for efficacy after the product has been subjected to simulated re-use procedures. The purpose of this method is to generate a product which has undergone simulated use and periodic bio-burden stressing.… Read More
Categories: Liquid Antimicrobial Efficacy Tests and Microbiology Testing
Tags: Antimicrobial, Antimicrobial Liquid, Cleaning Validation, Medical Device, Microbial Identification, Microbiology Testing, and Test
Reusable Medical Device Disinfection Validations
Low, Intermediate and High-Level Disinfection Validation for a Reusable Medical Device AAMI Method TIR12 AAMI TIR30 Purpose of Test The U.S. FDA requires that disinfection instructions supplied by medical device manufacturers to the end-users of reusable medical devices be validated to assure that they are appropriate for the device. AAMI Technical Information Reports (TIR) 12… Read More
Categories: Microbiology Testing
Tags: Antimicrobial, Cleaning Validation, Medical Device, Microbial Identification, Microbiology Testing, and Test
Disinfection Qualifications for Cleanroom Disinfectants
The following methods are used for Disinfection Qualifications for Clean-Room Disinfectants: USP <1072> ASTM E2614 Purpose of Test An effective disinfection program is critical to assure the quality of the products produced in aseptic processing areas of a Good Manufacturing Practice (GMP) facility. The U.S. FDA requires that, “the suitability, efficacy, and limitations of disinfecting… Read More
Categories: Microbiology Testing
Tags: Antimicrobial, Antimicrobial Liquid, Disinfection Qualification, Medical Device, Microbial Identification, Microbiology Testing, Pharmaceutical, and Test
AATCC 100 Assessment of Antibacterial Finishes on Textile Materials
Purpose of Test The AATCC 100 test method is a carrier-based test method used to evaluate the antibacterial activity of treated finishes on or in textile materials. This method is generally used to substantiate antibacterial properties of treated fabric for non-public health related claims. The method, although designed for fabric, may be modified to evaluate… Read More
Categories: Microbiology Testing
Tags: AATCC, Antimicrobial, Medical Device, Microbiology Testing, Test, and Treated Article Efficacy