Оценка биологическая медицинских изделий. Часть 11. Испытания на общую токсичность
Название (англ.):
Biological evaluation of medical devices; part 11: tests for systemic toxicity
Описание (англ.):
Specifies methodologies for the evaluation of the systemic toxicity potential of medical devices which release constituents into the body. Includes, in addition, pyrogenicity testing. The methods cited are from international standards, national standards, directives and regulations.
Дата регистрации:
01.01.94
Дата введения:
01.12.93
Код КГС:
Р29
Код ОКСТУ:
9409
Код ОКС(МКС):
11.100
Код ОКП:
9409
Нормативные ссылки:
prEN 30993-11-1994, EQV*EN ISO 10993-11-1995, EQV*DIN EN ISO 10993-11-1995, EQV*BS EN ISO 10993-11(1996/BSI), EQV*NF S99-511(1996/AFNOR), EQV*NF EN ISO 10993-11(1996/AFNOR), EQV ANSI/ADA 41*ASTM F 619-1986*ASTM F 750-1987*BS 5736-5-1982*ISO 10993-1-1992*ISO 10993-2-1992*ISO 10993-3-1992*SN 119800
Ключевые слова:
BIOASSAY BIOLOGICAL ANALYSIS AND TESTING DENTAL EQUIPMENT DETERMINATION IMPLANTS (SURGICAL) MEDICAL DEVICES MEDICAL EQUIPMENT SPECIMEN PREPARATION SURGICAL EQUIPMENT SURGICAL IMPLANTS TESTING TESTS TOXICITY