Số hiệu tiêu chuẩn
NF S99-201*NF EN ISO 14155
Tên tiêu chuẩn
Clinical investigation of medical devices for human subjects - Good clinical practice
Ngày phát hành
2011-03-01
Tiêu chuẩn tương đương
EN ISO 14155:2011,IDT * ISO 14155:2011,IDT
Tiêu chuẩn liên quan
DI 93/42/CE * DI 90/385/CE * ISO 14971
Thay thế cho
NF EN ISO 14155-1:200911 (S99-201-1) * NF EN ISO 14155-2:200911 (S99-201-2)
Thay thế bằng
NF EN ISO 14155:201205 (S99-201)
Lịch sử ban hành
NF EN ISO 14155:201205 (S99-201)*NF S99-201*NF EN ISO 14155*NF EN ISO 14155-1:200911 (S99-201-1)*NF EN ISO 14155-2:200911 (S99-201-2)
Từ khóa
Planning * Safety measures * Statistical methods of analysis * Approval * Personal * Definitions * Consumer-supplier relations * Data * Specifications * Legalization * Risk * Commissioning * Evaluations * Qualifications * Mathematical calculations * Medical equipment * Investigations * Technical documents * Personnel * Assessment * Quality assurance * Safety * Information * Acceptance * Expertises * Methods * Clinical testing * Training * Processes * Testing * Accident prevention * Documents * Procedures
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NF S99-201*NF EN ISO 14155
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