ISO 14155:1996 PDF
Clinical investigation of medical devices
Название (английский):
ISO 14155:1996
Clinical investigation of medical devices
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 12
- Дата публикации:
- 29 февраля 1996 г.
- Издание:
- ISO IS 14155 edition 1 version 1
- ICS:
- 11.100
Описание (английский):
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.
Технические детали
- Технический комитет
- ISO/TC 194 - Biological and clinical evaluation of medical devices
- SKU
- ISO 14155:1996