Pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment. Specifies the requirements for conducting the clinical investigation and documentation. Provides the framework for systematic written procedures for the organization, design, implementation and data collection.
Заменён стандартами:
ISO 14155-1:2003, ISO 14155-2:2003
Дата регистрации:
10.03.96
Дата введения:
01.03.96
Дата отмены:
06.03.03
Код КГС:
Р20
Код ОКСТУ:
9402
Код ОКС(МКС):
11.020
Код ОКП:
9402
Ключевые слова:
CLINICAL INVESTIGATIONS DEFINITIONS EFFICIENCY EVALUATIONS MEDICAL EQUIPMENT MEDICAL PRODUCTS SPECIFICATION (APPROVAL) TESTING SPECIFICATIONS