SureTek Quality

SureTek cleaning, testing, inspection, packaging and sterilization processes are implemented under rigorous design and process controls to ensure that each instrument is reprocessed under validated procedures.
SureTek Quality

Electromechanical testing and microscope inspection is performed by qualified technicians knowledgeable in the design and intended use of each device. Processes undergo extensive validation testing in accordance with industry standards to ensure that each reprocessed device remains safe and effective for its intended use following the maximum number of reprocessing cycles, including:

 

ASTM E2314-03 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)

ASTM HF18-2001 Electrosurgical Devices

ISO 11607-1 Packaging for Terminally Sterilized Medical Devices

ASTM F88-05 Standard Test Method for Seal Strength of Flexible Barrier Materials

ASTM F2096-04 Standard Test Method for Leak Testing Using Bubble Emission Techniques

ASTM D4169-05 Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM F1980-02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages

ISO 11135:1994 Medical devices — Validation and routine control of ethylene oxide sterilization

ISO 10993 Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity
Part 7: Ethylene oxide sterilization residuals
Part 10: Tests for irritation and delayed-type hypersensitivity

ISO 14971:2000 Medical devices — Application of risk management to medical devices