ISO 14971 AMD 1

Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements

2003-03-00

Hết hiệu lực

DIN EN ISO 14971/A1 (2003-10), IDT * EN ISO 14971/A1 (2003-03), IDT * NF S99-211/A1 (2004-02-01), IDT * OENORM EN ISO 14971/A1 (2003-09-01), IDT * PN-EN ISO 14971/A1 (2006-07-07), IDT * SS-EN ISO 14971/A1 (2003-11-07), IDT * UNE-EN ISO 14971/A1 (2003-10-03), IDT * CSN EN ISO 14971 (2001-12-01), IDT * DS/EN ISO 14971/A1 (2003-06-10), IDT * NEN-EN-ISO 14971:2001/A1:2003 en (2003-04-01), IDT

ISO 14971 (2000-12)

IEC 62A/412/FDIS (2002-11) * ISO 14971 FDAM 1 (2002-10)

ISO 14971 (2007-03)

ISO 14971 (2007-03) * ISO 14971 AMD 1 (2003-03) * IEC 62A/412/FDIS (2002-11) * ISO 14971 FDAM 1 (2002-10) * ISO 14971 DAM 1 (2001-10) * IEC 62A/364/CDV (2001-10)

Acceptance * Accessories * Analysis * Applications * Assessment * Biological hazards * Checks * Components * Contact * Context * Creation * Definitions * Diagnosis * Dotted lines * Energy * 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 * Properties * Public health * Qualifications * Qualitative * Quantitative * Risk * Risk analysis * Safety * Safety measures * Safety tests * Specification (approval) * Use * Generation * Procedures * Reduction * Implementation * Processes

11.040.01. Thiết bị y tế nói chung

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