Оценка биологическая медицинских изделий. Часть 6. Испытания для определения локальных эффектов после имплантации
Название (англ.):
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
Описание (англ.):
Specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices whose clinical acceptability has been established. The test methods for local effects after implantation are used toassess subchronic effects (short-term, up to 12 weeks), or chronic effects (long-term, longer than 12 weeks).
Дата регистрации:
01.09.94
Дата введения:
01.07.94
Код КГС:
Р29
Код ОКСТУ:
9396
Код ОКС(МКС):
11.100
Код ОКП:
9396
Нормативные ссылки:
EN 30993-6-1994, EQV*DIN EN 30993-6-1994, EQV*NF S99-506(1995/AFNOR), EQV*NF EN 30993-6(1995/AFNOR), EQV*BS EN 30993-6(1995/BSI), EQV ISO 10993-1-1992*ISO 10993-2-1992
Ключевые слова:
BIOASSAY BIOLOGICAL ANALYSIS AND TESTING DENTAL EQUIPMENT DETERMINATION IMPLANTS (SURGICAL) MEDICAL EQUIPMENT MEDICAL SCIENCES SURGICAL EQUIPMENT SURGICAL IMPLANTS MEDICINE