GOST R 50444-92

ГОСТ Р 50444-92

Medical instruments, apparatus and equipment. General specifications

Приборы, аппараты и оборудование медицинские. Общие технические условия

Status: Effective. IUS 3-1993

This standard applies to medical equipment products intended for use in medical practice, as well as to the components of these products that have functional medical purpose and are manufactured separately: medical devices; medical devices; medical equipment; medical complexes. The standard does not apply to: X-ray medical devices according to GOST 26140; eyeglass optics (glasses for optical vision correction, eyeglass frames, spectacle and contact lenses); personal eye and face protection

Настоящий стандарт распространяется на изделия медицинской техники, предназначенные для применения в медицинской практике, а также на составные части этих изделий, имеющие функциональное медицинское назначение и изготовляемые отдельно: медицинские приборы; медицинские аппараты; медицинское оборудование; медицинские комплексы. Стандарт не распространяется на: рентгеновские медицинские аппараты по ГОСТ 26140; изделия очковой оптики (очки для оптической коррекции зрения, оправы очков, очковые и контактные линзы); средства индивидуальной защиты глаз и лица

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Format: Electronic (pdf/doc)
Page Count: 45

Approved: Gosstandart of Russia, 12/22/1992

SKU: RUSS72214

Price: $286.95

English keywords: appliances;

National keywords: приборы;


The Product is Contained in the Following Classifiers:

PromExpert » SECTION I. TECHNICAL REGULATION » V Testing and control » 4 Testing and control of products » 4.13 Testing and control of products of engineering industry » 4.13.2 Machines and equipment for special purposes » 4.13.2.11 Equipment and instruments for medical industry »

ISO classifier » 11 HEALTH » 11.040 Medical equipment » 11.040.01 Medical equipment in general »

National standards » 11 HEALTH » 11.040 Medical equipment » 11.040.01 Medical equipment in general »


The Document References:

GOST 10354-82: Polyethylene film Specifications

GOST 12.1.028-80: System of the standards for safety of work

GOST 12082-82: Roof boarding for consignments up to 500 kg. General specifications

GOST 12969-67: Plates for machines and devices. Technical requirements

GOST 14192-77: Marking of cargoes

GOST 15150-69: Machines, instruments and other industrial products. Modifications for different climatic regions. Categories, operating, storage and transportation conditions as to environment climatic aspects influence

GOST 15151-69: Machines, instuments and other industrial products for tropics. General specifications.

GOST 15158-78: Paper and board with protective coating for packaging of goods and production of spare parts utilized in tropics. Specifications

GOST 15846-2002: Production for transportation to the areas of Far North and similar regions. Packing, marking, transportation and storage

GOST 17308-88: Twines. Specifications

GOST 1770-74: Laboratory volumetric glassware. Cylinders, beakers, measuring flasks, test tubes. General specifications

GOST 18251-87: Gummed tape on paper substrate. Specifications

GOST 18510-87: Writing paper

GOST 2.602-95: Unified system for design documentation. Repair documents

GOST 20477-86: Polyethylene tape with adhesive layer. Specifications

GOST 2228-81: Paper for bags

GOST 23436-79: Cable paper for insulation of power cables for voltage up to 35 kV inclusively. Specifications

GOST 23941-2002: Noise of machines. Methods for determination of noise characteristics. General requirements

GOST 24346-80: Vibration. Terms and definitions

GOST 25336-82: Laboratory glassware and equipment. Basic parameters and dimensions

GOST 26140-84: Medical x-ray units

GOST 26663-85: Transport packets. Formation by packaging means. General technical requirements

GOST 26828-86: Instrumentation and machine building products. Marking

GOST 2697-83: Roofing asphalt felt. Specifications

GOST 2991-85: Wooden uncollapsible cases for weights up to 500 kg. General specifications

GOST 3282-74: General-purpose low-carbon steel wire. Specifications

GOST 3560-73: Sealing tepe

GOST 4233-77: Reagents. Sodium chloride. Specifications

GOST 515-77: Bitumized and tarred packaging paper

GOST 5959-80: Uncollapsable wooden sheet material boxes for weights to 200 kg mass. General specifications

GOST 6709-72: Distilled water. Specifications

GOST 8.009-84: State system for ensuring the uniformity of measurements. Standardized metrological characteristics of measuring instruments

GOST 8.383-80: State system for ensuring the uniformity of measurements. State tests of means for measurements. General statements

GOST 8.395-80: Standard measurement conditions for calibration

GOST 8273-75: Packing paper

GOST 8828-89: Base paper and two-layer waterproof packaging paper

GOST 9.014-78: Unified system of corrosion and ageing protection. Temporary corrosion protection of products. General requirements

GOST 9.032-74: Unified, system of corrosion and ageing protection. Paint coatings. Groups, technical requirements and designations

GOST 9.048-89: Unified system of corrosion and ageing protection. Technical items. Methods of laboratory tests for mould resistance

GOST 9.083-78: Unified system of corrosion and ageing protection. Paint coatings. Accelerated test methods for durability in liquid corrosive mediums

GOST 9.301-86: Unified system of corrosion and ageing protection. Metal and non-metal inorganic coatings. General requirements

GOST 9.302-88: Unified system of corrosion and ageing protection. Metal and non-metal inorganic coatings. Control methods

GOST 9.707-81: Unified system of corrosion and ageing protection. Polymeric materials. Methods of accelerated climatic ageing test

GOST 9142-90: Boxes of corrugated board. General specifications

GOST 9569-2006: Paraffined paper. Specifications

GOST R 50460-92: Mark of conformity for obligatory certification form, dimensions dnd technical requirements

GOST R 51318.11-99: Electromagnetic compatibility of technical equipment. Radio disturbance from industrial, scientific, medical and domestic (ISMD) radio-frequency equipment. Limits and test methods

GOST R 51318.14.1-99: Electromagnetic compatibility of technical equipment. Radio disturbance from household appliances, electric tools and similar apparatus. Limits and test methods

GOST R 51320-99: Electromagnetic compatibility of technical equipment. Man-made radio disturbance. Test methods for technical equipment which are man-made radio disturbance sources

GOST R 51350-99: Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 1. General requirements

GOST R 52319-2005: Safety requirements for electrical equipment for measurement, control and laboratory use. Part 1. General requirements

GOST R 52901-2007: Corrugated board for products packaging. General specifications

PR 50.2.006-94: Procedure for calibration of measurement equipment

PR 50.2.009-94: The testing and approval procedure for the measurement instrumentation

The Document is Referenced By:

GOST R 15.013-2016: System of products development and launching into manufacture. Medical devices

GOST R 50267.0-92: Medical electrical equipment. Part 1. General safety requirements

GOST R 50925-96: Climatic tests for electric wheelchairs

GOST R 51024-2012: Medical electronics hearing aids. Technical requirements and test methods

GOST R 51024-97: Electronics hearing aids. General specifications

GOST R 51073-97: Implantable cardiac pacemakers. General specifications and basic test methods

GOST R 51076-2017: Speech hearing aids trainers. General specifications

GOST R 51219-98: Manufactured articles medical elasticity for the fixation and compression. General technical requirements. Test methods

GOST R 51260-2017: Rehabilitation aids trainers. General technical requirements

GOST R 51260-99: Rehabilitation simulators for disabled persons. General specifications

GOST R 51632-2014: Technical aids for disabled persons. General technical requirements and test methods

GOST R 51959.1-2002: Non-invasive sphygmomanometers (measuring devices of arterial pressure). Part 1. General requirements

GOST R 53466-2009: Optics and optical equipment. Medical thermographs. General technical requirements. Methods of measuring the major parameters

GOST R 53469-2009: Optics and optical instruments. Medical endoscopes and endotherapy devices. Part 1. General requirements

GOST R 53868-2010: Units of lower-limb prostheses for children. Technical requirements and test methods

GOST R 54794-2011: Analysers of the content of ethanol. General specifications

GOST R 55483-2013: Meat and meat products. Determination of fatty acids composition by gas chromatography

GOST R 55719-2013: Medical electrical equipment. Demands to the contents and veneering of technical projects for the competitive documentation at carrying out of the state purchases of the highly technological medical equipment

GOST R 55953-2014: Medical electrical equipment. Anaesthetic workstation. Technical requirements for public procurement

GOST R 55992.1-2014: In vitro diagnostic medical devices for fluorescent and immunofluorescent analysis of «dried spot» of newborn’s blood. Part 1. Instruments and accessories for fluorescent and immunofluorescent analysis of «dried spot» of newborn’s blood. Technical requirements for state to buy in

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GOST R 56279-2014: Medical electrical equipment. Endoscopic racks. Specifications for governmental purchase

GOST R 56280-2014: Medical electrical equipment. Neurosurgical operating racks with a set of endoscopes. Specifications for governmental purchase

GOST R 56317-2014: Medical electrical equipment. Systems of dose planning. Technical requirements for governmental purchases

GOST R 56318-2014: Medical electrical equipment. Gamma-therapy distant equipment for radiotherapy. Technical requirements for governmental purchases

GOST R 56319-2014: Medical electrical equipment. Gamma-therapy equipment for brachytherapy. Technical requirements for governmental purchases

GOST R 56321-2014: Medical electrical equipment. Medical cyclotrons with energy to 20 MэV for radioactive isotopes. Technical requirements for governmental purchases

GOST R 56327-2014: Medical electrical equipment. Ultrasonic equipment of expert class. Technical requirements for governmental purchases

GOST R 56328-2014: Medical equipment. Mobile complexes for medical purpose. General specifications and test methods

GOST R 56330-2014: Medical equipment. Technical means of placement and transfer of patients in the prehospital. General specifications and test methods

GOST R 56330-2016: Medical equipment. Technical means of placement and transfer of patients in the prehospital. General technical requirements and test methods

GOST R 56331-2014: Medical electrical equipment. Medical diagnostic ultrasonic equipment. Technical requirements for governmental purchases

GOST R 56607-2015: Medical electrical equipment. Gamma-knifes for radiotherapy. Technical requirements for governmental purchases

GOST R 57492-2017: Medical devices. Implantable cardiac pacemakers. Technical requirements for governmental purchases

GOST R 57495-2017: Medical devices. Implantable neurostimulators. Technical requirements for governmental purchases

GOST R 57497-2017: Medical devices. Implantable active devices intended to circulatory support. Technical requirements for governmental purchases

GOST R 57498-2017: Medical devices. X-Ray therapy apparatus with anode voltage from 10 to 300 kV. Technical requirements for governmental purchases

GOST R 57500-2017: Medical devices. Implantable infusion pumps. Technical requirements for governmental purchases

GOST R 57502-2017: Medical equipment. Industrial production regulation

GOST R 57505-2017: Medical devices. Cochlear implant system. Technical requirements for governmental purchases

GOST R 57506-2017: Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases

GOST R 57620-2017: Dentistry. Refractory investment and die material. Technical requirements. Test methods

GOST R 57764-2017: Support canes and crutches axillary. Technical requirements and methods of control

GOST R 57765-2017: Products prosthetic-orthopedic. General technical requirements

GOST R 57766-2017: Chairs with medical equipment. Types, technical requirements and methods of control

GOST R 57768-2017: Orthopedic bandages for joints of the upper and lower extremities. Types and basic parameters

GOST R 57769-2017: Antidecubital mattresses and pillows. Types and basic parameters

GOST R 57770-2017: Orthopedic mattresses. Types and basic parameters

GOST R 57771-2017: Electronic units of the prostheses of the upper and lower limb. Technical requirements

GOST R 57892-2017: Spinal assistants and headholders. Тechnical requirements and test methods

GOST R 58024-2017: Medical devices. Equipment for thermal disinfection/neutralization of medical waste. Dry hot air method. Technical requirements for governmental purchases

GOST R 58281-2018: Crutches cane support. Technical conditions

GOST R ISO 7886-4-2009: Sterile hypodermic syringes for single use. Part 4. Syringes with re-use prevention feature

GOST R ISO 9694-2003: Dental phosphate-bonded casting investments. General specifications

MR 2.1.10.0073-13: Prevention of respiratory diseases in children living in conditions of aerogenic effects of manganese and its compounds

MU 1.2.2740-10: Sampling procedure for identifying, identifying and characterizing the action of nanomaterials in aquatic invertebrates

MU 1.2.2741-10: Sampling procedure for the identification and identification of nanomaterials in laboratory animals

MU 1.2.2744-10: Sampling procedure for the identification and identification of nanomaterials in fish

MU 1.2.2745-10: Sampling procedure for characterizing the action of nanomaterials on laboratory animals

MUK 4.1.2907-11: Determination of residual progexadione-calcium in water, soil, fruits and juice of apples using high performance liquid chromatography

MUK 4.1.2923-11: Determination of residues of imidacloprid in carrots, onions, peas, grains and straw of rice, grains and soybean oil, berries and grape juice by high performance liquid chromatography

MUK 4.1.2924-11: Determination of residues of isoproturon and diflufenicane in water, soil, grain and straw of grain crops using high performance liquid chromatography

MUK 4.1.2925-11: Determination of residues of fenpyroximate in green mass, grain and soybean oil by high performance liquid chromatography

MUK 4.1.3093-13: Chromato-mass spectrometric determination of methyl tert-butyl ether in water

MUK 4.1.3313-15: Method for measuring the mass concentration of 4-hydroxy-3- [1, 2, 3, 4-tetrahydro-3- [4- (4-trifluoromethyl-benzoyloxy) phenyl] -1-naphthylcoumarin, mixture (1R, 3R) -and (1R, 3S) -isomers (flocoumafen) in the air of the working area by high performance

MUK 4.1.3314-15: Method for measuring the mass concentration of 40-O- (2-hydroxyethyl) -rapamycin (everolimus) in the air of the working area by high-performance liquid chromatography

MUK 4.1.3315-15: Methods for measuring the mass concentration of 7 - [[6-O- (6-deoxy-alpha-L-mannopyranosyl) -beta-D-gluco-pyranosyl] oxy] -5-hydroxy-2- (3-hydroxy-4-methoxyphenyl) -4H-1-benzopyran-4-one (diosmin), 7 - [[6-O- (6-deoxy-alpha-L-mannopyranosyl) -beta-D-gluco

MUK 4.1.3316-15: Method for measuring the mass concentration of 3- {3 - [{[(7S) -3, 4-dimethoxybicyclo [4.2.0] octa-1, 3, 5-triene-7-yl] methyl} (methyl) amino ] propyl} -7, 8-dimethoxy-1, 3, 4, 5-tetrahydro-2H-3-benzazepin-2-one hydrochloride (ivabradine hydrochloride, c

MUK 4.1.3317-15: Method for measuring the mass concentration of [(1R) -3-methyl-1 - [[(2S) -1-oxo-3-phenyl-2 - [(pyrazinyl-carbonyl) amino] propyl] amino] butyl] boronic acids (bortezomib) in the air of the working area by high performance liquid chromatography

MUK 4.1.3318-15: Method for measuring the mass concentration of 4 - [(4-Methyl-1-piperazinyl) methyl] -N- [4-methyl-3 - [[4- (3-pyridinyl) -2-pyrimidinyl] amino] phenyl] Benzamide monomethylsulfonate (imatinib mesilate) in the air of the working area by high performance l

MUK 4.1.3319-15: Methods for measuring the mass concentration of 6-O-methylerythromycin (clarithromycin) in the air of the working area using spectrophotometry

MUK 4.1.3320-15: Method for measuring the mass concentration of N- (1-oxopentyl) -N - [[2 '- (1H-tetrazol-5-yl) [1, 1'-biphenyl] -4-yl] methyl] -L- valine (valsartan) in the air of the working area using spectrophotometry

MUK 4.1.3321-15: Methods of measuring the mass concentration (/ -) - 4'-cyano-alpha, alpha, alpha-trifluoro-3 - [(4-fluorophenyl) sulfonyl] -2-hydroxy-2-methyl-m-propionotoluidide ( bicalutamide) in the air of the working area by high performance liquid chromatography

MUK 4.1.3333-16: Method for measuring the mass concentration of methyl- () - (S) -alpha- (o-chlorophenyl) -6, 7-dihydrothieno [3, 2-c] pyridine-5 (4H) -5 (4H) -acetate hydrosulphate (clopidogrel hydrosulphate) in the air of the working area using spectrophotometry

MUK 4.1.3334-16: Method for measuring the mass concentration of 2-butyl-4-chloro-1 - [[2 '- (1H-tetrazol-5-yl) [1, 1'-biphenyl] -4-yl] methyl] -1H- imidazole-5-methanol monopotassium salt (potassium losartan) in the air of the working area using spectrophotometry

MUK 4.1.3335-16: Method for measuring the mass concentration of 1-ethyl-6-fluoro-1, 4-dihydro-4-oxo-7- (1-piperazinyl) -3-quinoline-carboxylic acid (norfloxacin) in the air of the working area using spectrophotometry

MUK 4.1.3336-16: Mass Concentration Measurement Technique [2S- [1- [R * (R *)], 2alf, 3alf beta, 7alf beta]] - 1- [2 - [[1- (ethoxycarbonyl) butyl] amino] - 1-oxopronyl] octagidro-1H-indole-2-carboxylic acid salt with 2-methyl-2-propanamine (1: 1) (perindopril erbumin) in

MUK 4.1.3421-17: Measurement of mass concentration of trans-4- (aminomethyl) cyclohexanecarboxylic acid (tranexamic acid) in the air of the working area using spectrophotometry

MUK 4.1.3422-17: Measurement of the mass concentration of (R *, R *) - (+/-) - N- [2-hydroxy-5- [1-hydroxy-2 - [[2- (4-methoxyphenyl) -1-methylethyl] amino] ethyl ] phenyl] formamide fumarate (2: 1) dihydrate (formoterol fumarate dihydrate) in the air of the working area

MUK 4.1.3423-17: Measurement of the mass concentration of 2-hydroxypropane-1,2,3-tricarbonate trisodium dihydrate (sodium citrate trisubstituted dihydrate, trisodium citrate dihydrate) in the air of the working area using spectrophotometry

MUK 4.1.3424-17: Measurement of the mass concentration of 6- [O- (1,1-dimethylethyl) -D-serine] -9- (N-ethyl-L-prolinamide) -10-deglycinamide releasing factor of luteinizing hormone (porcine) acetate (buserelin acetate) in airborne working area by high performance liquid

MUK 4.1.3425-17: Measurement of the mass concentration of 2- [2- (4-dibenzo [b, f] [1,4] thiazepin-11-yl-1-piperazinyl) ethoxy] ethanol fumarate (2: 1) (quetiapine fumarate) in the working zone air spectrophotometry

MUK 4.1.3426-17: Measurement of the mass concentration of (1S, 2S, 3R, 5S) -3- [7 - {[(1R, 2S) -2- (3,4-difluorophenyl) cyclopropyl] amino} -5- (propylthio) -3H-1, 2,3-triazolo [4,5-d] pyrimidin-3-yl] -5- (2-hydroxyethoxy) cyclopetan-1,2-diol (ticagrelor) in the air of th

MUK 4.1.3427-17: Measurement of the mass concentration of the complex compound inosine with the salt of mono [4-acetylamino) benzoate] with 1- (dimethylamino) -2-propanol (1: 3) (inosine pranobex) in the air of the working area using spectrophotometry

MUK 4.1.3428-17: Measurement of the mass concentration of sodium dodecyl sulfate (sodium lauryl sulfate) in the air of the working area using spectrophotometry

MUK 4.1.3429-17: Measurement of the mass concentration of 5-methoxy-2 - [(S) - [(4-methoxy-3,5-dimethyl-2-pyridinyl) methyl] sulfinyl] -1H-benzimidazole magnesium trihydrate (salt) (esomeprazole magnesium trihydrate) in the air working area by high performance liquid chro

MUK 4.1.3430-17: Measurement of the mass concentration of (+/-) - 1- [4- (2-methoxyethyl) phenoxy] -3 - [(1-methylethyl) amino] -2-propanol tartrate (2: 1) (metoprolol tartrate) in the air of the working area by high performance liquid chromatography

MUK 4.1.3431-17: Measurement of the mass concentration of alpha, alpha, alpha ', alpha'-tetramethyl-5- (1H-1,2,4-triazol-1-ylmethyl) -1,3-benzene diacetonitrile (anastrozole) in the air of the working area by high-performance liquid chromatography

MUK 4.1.3432-17: Measurement of the mass concentration of (+/-) - 2-ethoxy-1 - [[2 '- (1H-tetrazol-5-yl) [1,1'-biphenyl] -4-yl] methyl] -1H-benzimidazol-7 -carboxylic acid 1 - [[(cyclohexyloxy) carbonyl] oxy] ethyl ester (candesartan cilexetil, candesartan) in the air of

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GOST R 58280.1-2018: Medical Products. Equipment for thermal disinfection / disposal of medical waste. The method of dry hot air. Part 1. General requirements

GOST R 58280.2-2018: Medical Products. Equipment for thermal disinfection / disposal of medical waste. Dry hot air method and saturated water vapor method. Part 2. Control and test methods

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