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ISO/TR 24971:en

Medical devices -- Guidance on the application of ISO 14971

Số trang: 13
Ngày phát hành: 2015-02-06

Liên hệ
This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management. The guidance is intended to assist manufacturers and other users of the standard to:
Số hiệu tiêu chuẩn
ISO/TR 24971:en
Tên tiêu chuẩn
Medical devices -- Guidance on the application of ISO 14971
Ngày phát hành
2015-02-06
Trạng thái
Có hiệu lực
Tiêu chuẩn tương đương
ISO/TR 24971:2013, IDT
Tiêu chuẩn liên quan
Thay thế cho
Thay thế bằng
Lịch sử ban hành
ISO/TR 24971:en (2015-02)
Từ khóa
ACCEPTANCE * ACCESSORIES * ANALYSIS * APPLICATIONS * ASSESSMENT * BIOLOGICAL HAZARDS * CHARACTERISTICS * CHECKS * COMPONENTS * CONTACT * CONTEXT * DIAGNOSIS * ENERGY * ENVIRONMENTAL HAZARDS * ESTABLISHMENT * EVALUATIONS * EXAMINATION (QUALITY ASSURANCE) * GUIDE BOOKS * HANDLING * HAZARDS * HEALTH HAZARDS * IMPLEMENTATION * IN VITRO * IN-VITRO DIAGNOSTIC * LOSS * MANAGEMENT * MATERIALS * MEDICAL DEVICES * MEDICAL EQUIPMENT * MEDICAL PRODUCTS * MEDICAL SCIENCES * MEDICAL TECHNOLOGY * METHODS * PERSONAL HEALTH * PERSONNEL * PLANNING * PROCEDURES * PROCESSES * PRODUCTION * PROPERTIES * PUBLIC HEALTH * QUALIFICATIONS * QUALITATIVE * QUALITY MANAGEMENT * QUANTITATIVE * REDUCTION * RISK * RISK ANALYSIS * SAFETY * SAFETY MEASURES * SAFETY TESTS * SPECIFICATION (APPROVAL) * SURVEILLANCE (APPROVAL) * USE * Surveillance (approval) * Materials * Acceptance * Biological hazards * Methods * Management * Mission * Cloth * Establishment * Examination (quality assurance) * Properties * Regional planning * Use * Environmental hazards * Processes * Administration * Medical sciences * Quantitative * Energy * Handling * Health hazards * Aids * Loss * Safety * Public health * Checks * Reduction * Corporate governance * Risk * Medical technology * Medical equipment * Accessories * Reception * Operation * Safety tests * Assessment * Characteristics * Components * Analysis * Approval * Fabrics * Inserts * In vitro * Diagnosis (medical) * Personnel * Hazards * Quality management * Evaluations * Qualitative * Context * Guide books * Qualifications * Office management * Medical products * In-vitro diagnostic * Medical devices * Procedures * Planning * Implementation * Diagnosis * Ingredients * Contact * Applications * Substances * Personal health * Safety measures * Risk analysis * Production * Legalization * Specification (approval)
Mục phân loại
Số trang
13