GOST R 50444-92
ГОСТ Р 50444-92
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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)
Approved: Gosstandart of Russia,
12/22/1992
SKU: RUSS72214
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 »
National standards »
11 HEALTH »
11.040 Medical equipment »
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 »
National Standards for KGS (State Standards Classification) »
Latest edition »
R Health. Sanitation and hygiene items »
R2 Equipment and tools of medical institutions »
R20 Classification, nomenclature and general norms »
National Standards for OKSTU »
MEDICAL EQUIPMENT »
Medical devices and apparatus »
The Document is Replaced With:
GOST R 50444-2020: Medical devices, apparatus and equipment. General technical requirements
As a Replacement Of:
GOST 20790-82: Medical instruments, apparatus and equipment. General specifications
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
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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
RD 50-707-91: Guidelines. Products of medical equipment. Requirements for reliability. Rules and methods for monitoring reliability indicators
The Document is Referenced By:
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GOST 21643-2022: Medical staplers. General technical conditions
GOST 25047-87: Complete exfusion, infusion and transfusion devices of the single application
GOST 26997-2002: Heart valve prostheses. General specifications
GOST R 15.013-2016: System of products development and launching into manufacture. Medical devices
GOST R 22.8.04-96: Safety in emergencies. Technical washing means for people disinfection. Disinfection shower unit. General technical requirements
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
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GOST R 51316-99: Medical monoplaced fixed barochambers. General technical requirements
GOST R 51566-2000: Vascular prostheses. General requirements. Test methods
GOST R 51632-2000: Technical aids for disabled persons. General technical requirements and test methods
GOST R 51632-2014: Technical aids for disabled persons. General technical requirements and test methods
GOST R 51633-2000: Devices and adapters, which are used to rehabilitation of individuals with disabilities at home. General technical requirements
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GOST R 53220-2008: Meat and meat products. Electrophoretic method of determination of soy proteins
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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 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
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GOST R 57502-2017: Medical equipment. Industrial production regulation
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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 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
GOST R 58280.3-2018: Medical Products. Equipment for thermal disinfection / disposal of medical waste. Dry hot air method and saturated water vapor method. Part 3. Requirements for samples, consumables, documentation
GOST R 58281-2018: Crutches cane support. Technical conditions
GOST R 58507-2019: Electric wheelchairs and scooter. General specifications
GOST R 58523-2019: Hip abduction apparatus for children. Technical requirements and test methods
GOST R 58551-2019: Medical disposable products from nonwoven materials. Clothes and surgical disposable non-woven fabrics. Technical Requirements for Public Procurement
GOST R ISO 10535-99: Household hoists for disabled persons. Technical requirements and test methods
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 4.1.3312-15: Method for measuring the mass concentration of 3-benzoyl-alpha-methylbenzeneacetic acid (ketoprofen) in the air of the working zone by spectrophotometry
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
MUK 4.1.3476-17: Measurement of mass concentration of fluoride ions in hair samples by potentiometric method using an ion-selective electrode
PNST 62-2015: Autonomous air disinfecting-cleaner. Specifications
R 3.1.683-98: Use of ultra-violet bactericidal radiation for the disinfection of air and surfaces in inner premises
TU 9462-001-84299122-2010: Ampoules medical colorless and brown from glass of the 1st hydrolytic class
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