GOST 20790-93
ГОСТ 20790-93
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Medical instruments, apparatus and equipment. General specifications
Приборы, аппараты и оборудование медицинские. Общие технические условия
Status: Valid - Supersedes
The standard applies to medical equipment products intended for use in medical practice, as well as to the component parts 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. The standard establishes requirements for products manufactured for national economy and exports to countries with a temperate and tropical climate.
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. Стандарт устанавливает требования к изделиям, изготовляемым для народного хозяйства и экспорта в страны с умеренным и тропическим климатом.
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Format: Electronic (pdf/doc)
Approved: Gosstandart of Russia,
3/12/1996
SKU: RUSS73348
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 »
11.040.99 Other medical equipment »
National standards »
11 HEALTH »
11.040 Medical equipment »
11.040.99 Other medical equipment »
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 »
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 12.2.025-76: Medical equipment. Electrical safety
GOST 12082-82: Roof boarding for consignments up to 500 kg. General specifications
GOST 12969-67: Plates for machines and devices. Technical requirements
GOST 14192-96: Cargo marking
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 16842-82: Industrial radio-interferences. Test methods for radio-interference sources
GOST 17308-88: Twines. Specifications
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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
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GOST 23436-83: Cable paper for insulating power cables for voltage up to 35 kv inclusively
GOST 23450-79: Industrial radio noise from industrial, science, medical and domestic high-frequency equipment standards and measuring methods
GOST 23511-79: Industrial radio frequency interference generated by domestic electrical appliances used in residential buildings, or connected to domestic power sources
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 28197-90: National conformity mark. Form, sizes and technical requirements
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GOST 30324.0-95: Medical electrical equipment. Part 1. General safety requirements
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GOST 7376-89: Corrugated paperboard
GOST 8.009-84: State system for ensuring the uniformity of measurements. Standardized metrological characteristics of measuring instruments
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 9569-79: Paraffin paper
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 51402-99: Noise of machine. Determination of power levels of noise sources using sound pressure. Survey method using an enveloping measurement surface over a reflecting plane
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:
GOST 10782-85: Glass bottles for blood, transfusion and infusion preparations/compounds
GOST 12.2.025-76: Medical equipment. Electrical safety
GOST 21643-2022: Medical staplers. General technical conditions
GOST 22649-83: Medical air sterilizers
GOST 25047-87: Complete exfusion, infusion and transfusion devices of the single application
GOST 25148-82: Stationary dental units
GOST 26997-2002: Heart valve prostheses. General specifications
GOST 28311-89: General purpose equipment designed for determination of key parameters of vibration processes
GOST 28386-89: Equipment for hyperbaric oxygenation
GOST 28603-90: Devices for uhf-therapy
GOST 28703-90: Automatic and semi-automatic instruments for indirect measurement of arterial pressure
GOST 29329-92: Balance for static weightings
GOST 302-79: Medical maximum glass thermometer. Specifications
GOST 30324.0-95: Medical electrical equipment. Part 1. General safety requirements
GOST 31212-2003: Implantable cardiac pacemakers. General specifications and basic test methods
GOST 31509-2012: Medical elastic manufactured articles for the fixation and compression. General technical requirements. Test methods
GOST 31512-2012: Medical monoplaced fixed barochambers. General technical requirements
GOST 31514-2012: Vascular prostheses. General technical requirements. Test methods
GOST 31515.1-2012: Non-invasive sphygmomanometers (measuring devices of arterial pressure). Part 1. General requirements
GOST 31516-2012: Medical maximum glass thermometrs. General specifications
GOST 31568-2012: Dental gypsum products. General specifications
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GOST 31570-2012: Nickel-base alloy billets for orthopedic dentistry. General specifications
GOST 31580.6-2012: Ophthalmic implants. Intraocular lenses. Part 6. Shelf-life and transport stability
GOST 31586-2012: Soft contact lenses. General specification
GOST 31627-2012: Corrosion-resistant cobalt-base alloy billets for orthopedic stomatology. General specifications
GOST 3302-95: Rubber ice-bags. Specification
GOST 33665-2015: Road ambulances. Technical requirements and test methods
GOST R 15.013-94: System of product development and launching into manufacture. Medical products
GOST R 51316-99: Medical monoplaced fixed barochambers. General technical requirements
GOST R 51381-99: Corrosion-resistant cobalt-base alloy billets for orthopaedic stomatology. General specifications
GOST R 51566-2000: Vascular prostheses. General requirements. Test methods
GOST R 51580-2000: Soft contact lenses. General specifications
GOST R 51632-2000: 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
GOST R 51633-2019: Rehabilitation devices and appliances used by people with disabilities in residential premises. General technical requirements
GOST R 51647-2000: Electronic aids for communication and information. Operational documents. Types and rules of implements
GOST R 51647-2018: Communication and information rehabilitation electronic. Operational documents. Types and rules of implementation
GOST R 51767-2001: Nickel-base alloy billets for orthopaedic dentistry. General specifications
GOST R 51887-2002: Dental gypsum products. General specifications
GOST R 51945-2002: Aspirators. General specifications
GOST R 51959.1-2002: Non-invasive sphygmomanometers (measuring devices of arterial pressure). Part 1. General requirements
GOST R 52040-2003: Ophthalmic implants. Intraocular lenses. Part 6. Shelf-life and transport stability
GOST R 52921-2008: Medical maximum glass thermometers. General specifications
GOST R 53129-2008: Corrosion-resistant (stainless) steel billets for cast dentures of orthopaedic dentistry. General specifications
GOST R 54040-2010: Production of plant growing and forages. Method of 137 Cs determination
GOST R 54794-2011: Analysers of the content of ethanol. General specifications
GOST R 56169-2014: Optics and optical instruments. Operation microscope. Requirements and test methods
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 57266-2016: Safes for storing drugs, psychotropic substances and their precursors. Requirements, classification and test methods
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 57500-2017: Medical devices. Implantable infusion pumps. Technical requirements for governmental purchases
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 57530-2017: Medical equipment for hyperbaric chambers under pressure. General technical requirements
GOST R 58936-2020: Optics and Photonics. Endoscopes and medical endotherapeutic devices. General technical requirements and test methods
GOST R 59878-2021: Voice-voicing apparatuses. Basic parameters and technical requirements
GOST R ISO 9694-2003: Dental phosphate-bonded casting investments. General specifications
IO 200-RSFSR-15-0045-80: Typical technology for routine maintenance of daily, first, second and seasonal technical services for KAMAZ-5320, KAMAZ-5410, KAMAZ-5511
MR 1.2.0022-11: Sampling procedure for nanomaterials control
MU 1.2.2741-10: Sampling procedure for the identification and identification of nanomaterials in laboratory animals
MU 2.3.975-00: Use of Bactericidal Ultraviolet Radiation for Decontamination of the Air in Rooms of Food Industry, Public Food Service, and Food Product Retail Facilities
MU 64-01-001-2002: Production of Pharmaceuticals. Terms and Definitions
MUK 4.1.1619-03: Photometric measurement of mass concentrations of beta-galactosidase in the air of the working area
MUK 4.1.1624-03: Photometric measurement of mass concentrations of beta-glucanase in the air of the working area
MUK 4.1.1640-03: Spectrophotometric measurement of mass concentrations of phytoliasis in the air of the working area
MUK 4.1.1642-03: Photometric measurement of mass concentrations of endo-1, 3b-xylanase (xylanase) in the air of the working area
MUK 4.1.2251-07: Measurement of mass concentrations of nickel tetracarbonyl (TKN) in the air of the working area using gas chromatography
MUK 4.1.2252-07: Measurement of mass concentrations of the amount of steroid saponins of Yukka Shidiger in the air of the working area using chromatography-mass spectrometry
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 4.1.3137-13: Measurement of the mass concentration of bis [1-hydroxypyridine-2 (1H) -thionate] zinc (pyrithione zinc) in the air of the working area using spectrophotometry
MUK 4.1.3138-13: Measurement of the mass concentration of (R) -3-hydroxy-alpha - [(methylamino) methyl] benzomethanol hydrochloride (phenylephrine hydrochloride) in the air of the working area using high performance liquid chromatography (HPLC)
MUK 4.1.3139-13: Measurement of the mass concentration of [2S- [1- [R * (R *)] 2 alpha, 3 alpha beta, 7 alpha beta]] - 1- [22 - [[1- (ethoxycarbonyl) butyl] amino] -1-oxopropyl] octahydro 1H-indole-2-carboxylic acid salt with L-arginines (1: 1) (perindopril arginine) in t
MUK 4.1.3140-13: Measurement of the mass concentration of N, N-dimethylimidodicarbonimide diamide hydrochloride (metformin hydrochloride) in the working area air using spectrophotometry
MUK 4.1.3476-17: Measurement of mass concentration of fluoride ions in hair samples by potentiometric method using an ion-selective electrode
MUK 4.1.986-00: Measurement method for measuring the mass fraction of lead and cadmium in food products and food raw materials using electrothermal atomic absorption spectrometry
NPB 185-99: Fire equipment. Fire fighting centrifugal pumps. General technical requirements. Test methods
OMU 42-21-27-88: Hyperbaric oxygenation devices. Operation and repair rules
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SP 319.1325800.2017: Buildings and premises of medikal institutions. The rules of operation
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