GOST R ISO 16061

Instrumentation for use in association with non-active surgical implants. General requirements

2011-00-00

Có hiệu lực

ISO 11135-1 (2007-05), IDT * ISO 11137-1 (2006-04), IDT * ISO 11137-2 (2006-04), IDT * ISO 11137-2 (2012-03), IDT * ISO 11137-3 (2006-04), IDT * ISO 11607-1 (2006-04), IDT * ISO 11607-2 (2006-04), IDT * ISO 14155-1 (2003-02), IDT * ISO 14155-2 (2003-05), IDT * ISO 14971 (2007-03), IDT * ISO 15223-1 (2007-04), IDT * ISO 15223-1 (2012-07), IDT * ISO 16061 (2008-12), IDT * ISO 17664 (2004-03), IDT * ISO 17665-1 (2006-08), IDT

ISO 11137-1 (2006-04) * ISO 11137-3 (2006-04) * ISO 11607-1 (2006-04) * ISO 11607-2 (2006-04) * ISO 14971 (2007-03) * ISO 17664 (2004-03) * ISO 17665-1 (2006-08) * ISO 11135-1 (2007-05) * ISO 11137-2 (2006-04) * ISO 14155-1 (2003-02) * ISO 14155-2 (2003-05) * ISO 15223-1 (2007-04)

GOST R ISO 16061 (2011)

Acceptance * Acceptance (approval) * Acceptance specification * Accessories * Active * Analysis * Applications * Assessment * Bearings * Biocompatibility * Biological hazards * Calibration * Capability of sterilization * Characterisations * Characteristics * Checks * Cleaning * Clearing * Clinical * Clinical investigations * Clinical testing * Closures * Commissioning * Compatibility * Components * Composition * Conditioning * Connections * Construction details * Consumer information * Consumer-supplier relations * Contact * Containers * Context * Control * Control charts * Covers * Creation * Cycle * Cyclic * Damage * Data of the manufacturer * Decontaminations * Definitions * Density * Dental equipment * Dental instruments * Design * Developments * Diagnosis * Disinfection * Disposables * Documentation * Dose * Dose distribution * Dosimeters * Dosimetry * Dotted lines * Dressing materials * Efficiency * Elections * Electron beams * Energy * Enterprises * Environmental hazards * Equipment * Establishment * Ethylene oxide * Evaluations * Examination (quality assurance) * Forming * Gamma-irradiation facility * Gamma-radiation * General conditions * Germicides * Germs * Graphic representation * Graphic symbols * Guide books * Handling * Hazards * Health hazards * Health protection * Heat * Heat sterilization * Human body * Humid * Hygiene * Implants (surgical) * In vitro * Inactive * Information * Information marks * Inscription * Inspection * Inspectors * Instructions * Instructions for use * Instrumentation * Instruments * In-vitro diagnostic * Ionizing radiation * Irradiation apparatus * Jets * Labelling * Labels * Large scale equipment * Loss * Maintenance * Management * Marking * Materials * Materials specification * Measurement * Measuring techniques * Medical devices * Medical equipment * Medical instruments * Medical products * Medical sciences * Medical technology * Methods * Microbiological * Microbiological analysis * Moisture * Operation * Operators (personnel) * Packages * Packaging material * Packaging tests * People * Performance * Performance testing * Permability * Personal health * Personnel * Phototherapy * Physical * Physical testing * Planning * Plant * Product information * Production * Products * Prohibition plates * Properties * Protection * Public health * Public health protection * Qualifications * Qualitative * Quality * Quality assurance * Quality management * Quantitative * Radiation * Radiation dose * Rating tests * Ray treatment * Reagents * Repair * Reports * Reprocessing * Results * Reuse * Risk * Risk analysis * Routine tests * Rules of procedure * Safety * Safety engineering * Safety measures * Safety requirements * Safety tests * Sampling methods * Sanitary engineering * Sealing * Selection * Sequence of operations * Shaping * Specification * Specification (approval) * Stability * Steam * Steam sterilization * Steam sterilizers * Sterile * Sterile barrier systems * Sterility * Sterilization (birth control) * Sterilization by irradiation * Sterilization (hygiene) * Sterilized goods * Sterilizers * Storage * Surgery * Surgical dressings * Surgical equipment * Surgical implants * Surgical instruments * Surveillance (approval) * Symbols * Systemology * Systems * Test persons * Testing * Toxicity * Transport * Treatment * Trials * Use * User information * Utilization * Validation * Ventilation * Verification * Visual inspection (testing) * X-rays * Junctions * Procedures * Generation * Tightness * Release * Compounds * Purification * Freedom from holes * Impermeability * Implementation * Tanks * Aids * Preparation * Processes * Reduction * Joints

01.080.20. Ký hiệu sơ đồ dùng trên thiết bị riêng biệt
11.040.01. Thiết bị y tế nói chung
11.040.30. Dụng cụ mổ xẻ
11.080.01. Thanh trùng và khử trùng nói chung
11.080.20. Khử trùng
11.080.30. Bao gói thanh trùng
11.080.99. Các tiêu chuẩn khác liên quan đến thanh trùng
11.100.20. Đánh giá sinh học các thiết bị y tế, Vi sinh y khoa, xem 07.100.10