Số hiệu tiêu chuẩn
FprEN ISO 14971
Tên tiêu chuẩn
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Ngày phát hành
2009-02-00
Tiêu chuẩn tương đương
DIN EN ISO 14971/A1 (2009-04), IDT * S99-211PR, IDT * ISO 14971 (2007-03), IDT * OENORM EN ISO 14971 (2009-03-15), IDT
Từ khóa
Acceptance * Accessories * Analysis * Applications * Assessment * Biological hazards * Characteristics * Checks * Components * Contact * Context * Creation * Definitions * Diagnosis * Dotted lines * Energy * English language * Environmental hazards * Establishment * Evaluations * Examination (quality assurance) * Handling * Hazards * Health hazards * In vitro * In-vitro diagnostic * Loss * Management * Materials * Medical devices * Medical equipment * Medical products * Medical sciences * Medical technology * Methods * Personal health * Personnel * Planning * Production * Properties * Public health * Qualifications * Qualitative * Quality management * Quantitative * Risk * Risk analysis * Safety * Safety measures * Safety tests * Specification (approval) * Surveillance (approval) * Use * Generation * Procedures * Reduction * Implementation * Processes