testing of medical devices

We offer following testing of medical devices according valid standards:
 
 

BIOBURDEN

ISO 11737-1:2018

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products

 

STERILITY

ISO 11737-2:2019

Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

 

CYTOTOXICITY

ISO 10993-5:2009

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

 

SKIN IRRITATION

ISO 10993-10:2010

Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

- testing of skin irritiation in vitro: Reconstructed human epidermis test method

- in vivo skin irritation testing on human volunteers

 

ACCELERATED AGING

ASTM F1980 - 16

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

 

ISO 22610:2018

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration

 

ISO 20743:2013

Textiles — Determination of antibacterial activity of textile products