Оценка биологическая медицинских изделий. Часть 7. Остатки при стерилизации этиленоксидом
Название (англ.):
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Описание (англ.):
Specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices and procedures for the measurement of EO and ECH. Does not apply for EO-sterilized devices that have no patient contact such as in vitro diagnostic devices.
EN ISO 10993-7-1995, EQV*DIN EN ISO 10993-7-1995, EQV*BS EN ISO 10993-7(1996/BSI), EQV*NF S99-507(1996/AFNOR), EQV*NF EN ISO 10993-7(1996/AFNOR), EQV ISO 10993-1-1992*ISO 10993-3-1992*ISO 10993-10-1995
Ключевые слова:
BIOLOGICAL TESTS CHEMICAL RESIDUES DEFINITIONS ETHYLENE OXIDE MEDICAL EQUIPMENT MEDICAL PRODUCTS MEDICAL SCIENCES RESIDUES STERILIZATION (HYGIENE) TESTING MEDICINE STERILIZATION