testing of medical devices
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