GOST 12.2.025-76

ГОСТ 12.2.025-76

Medical equipment. Electrical safety

Изделия медицинской техники. Электробезопасность

Status: Not effective - Canceled in the Russian Federation

The standard applies to medical devices - devices, instruments, equipment and tools (products) containing electrical circuits and designed to be powered from an external or internal source of electrical current. The standard establishes the general electrical safety requirements for medical equipment products to ensure the protection of the patient and staff from electric shock, as well as test methods for compliance with these requirements. The standard does not apply to: x-ray medical devices according to GOST 26.140 and products with ionizing radiation sources; special technological equipment of the medical industry; vehicles on which products of medical equipment are mounted; products of medical equipment, medical and technical requirements (MTT) for which are approved after January 1, 1991, and in the absence of MTT - for products whose development began after January 1, 1991.

Стандарт распространяется на изделия медицинской техники - аппараты, приборы, оборудование и инструменты (изделия), содержащие электрические цепи и рассчитанные на питание от внешнего или внутреннего источника электрического тока. Стандарт устанавливает общие требования электробезопасности, предъявляемые к изделиям медицинской техники с целью обеспечения защиты пациента и обслуживающего персонала от поражения электрическим током, а также методы испытаний на соответствие этим требованиям. Стандарт не распространяется на: рентгеновские медицинские аппараты по ГОСТ 26.140 и изделия с источниками ионизирующих излучений; специальное технологическое оборудование медицинской промышленности; транспортные средства, на которые монтируются изделия медицинской техники; изделия медицинской техники, медико-технические требования (МТТ) на которые утверждены после 01.01.91, а при отсутствии МТТ - на изделия, разработка которых начата после 01.01.91.

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Format: Electronic (pdf/doc)

Approved: USSR State Committee for Product Quality and Standards Management, 12/30/1976

SKU: RUSS19590

Price: $349.00


The Product is Contained in the Following Classifiers:

PromExpert » SECTION III. LABOR PROTECTION AND SAFETY » III Occupational safety requirements for production equipment and processes » 2 Safety requirements for certain types of work » 2.10 Operation of electrical installations, electrical equipment and power tools »

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 » 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 »

ISO classifier » 13 ENVIRONMENTAL PROTECTION, HUMAN PROTECTION AGAINST ENVIRONMENTAL IMPACT. SECURITY » 13.100 Safety of professional activity. Industrial hygiene »

National standards » 13 ENVIRONMENTAL PROTECTION, HUMAN PROTECTION AGAINST ENVIRONMENTAL IMPACT. SECURITY » 13.100 Safety of professional activity. Industrial hygiene »

National Standards for KGS (State Standards Classification) » Latest edition » T General technical and organizational and methodological standards » T5 Documentation System » T58 System of standards infield of nature conservation and improvement of use of natural resources, labor safety, scientific organization of labor »

National Standards for OKSTU » SYSTEMS OF GENERAL TECHNICAL AND ORGANIZATIONAL-METHODOLOGICAL STANDARDS » Occupational safety standards system (SSBT). Scientific organization of labor. Safety precautions. Sanitation and occupational health »

National Standards for OKSTU » MEDICAL EQUIPMENT » Rules for acceptance, use, operation and repair. Safety engineering »

The Document References:

GOST 12.4.026-76: Signal colors and safety signs

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 20790-82: Medical instruments, apparatus and equipment. General specifications

GOST 20790-93: Medical instruments, apparatus and equipment. General specifications

GOST 22261-94: Measuring instruments for electrical

GOST 26140-84: Medical x-ray units

GOST R 12.4.026-2001: Occupational safety standards system. Safety colors, safety signs and signal marking. Purpose and rules of application. General technical requirements and characteristics. Test methods

GOST R 50444-92: Medical instruments, apparatus and equipment. General specifications

The Document is Referenced By:

GOST 18856-81: Apparatuses for inhalation anesthesia and artificial pulmonary ventilation

GOST 19569-89: Steam medical sterilizers

GOST 19687-84: Electrocardiographs. General specifications

GOST 19687-89: Devices for heart bioelectric potentials measurement.

GOST 20790-82: Medical instruments, apparatus and equipment. General specifications

GOST 20790-93: Medical instruments, apparatus and equipment. General specifications

GOST 22340-89: Medical electrical water stills

GOST 22649-83: Medical air sterilizers

GOST 22744-84: Flame photometers. General specifications

GOST 23496-86: Endoscopes with fiber optics. General specifications

GOST 23496-89: Medical endoscopes

GOST 25148-82: Stationary dental units

GOST 26141-84: Amplifiers of x-ray images for medical roentgen apparatuses

GOST 26161-89: Operating tables

GOST 26368-90: Medical light fixtures

GOST 27072-86: Diagnostic acoustic generators of signals. Audiometers

GOST 28131-89: Dentist` s chairs

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 30345.0-95: Safety of household and similar electrical appliances. General requirements

GOST 4.324-85: Product-quality index system. Apparatus for ultrasonic therapeutics. Nomenclature of indices

GOST 4.370-85: Product-quality index system. Mechanical analysers of biological liquiods. Nomenclature of indices

GOST 4.372-85: Product-quality index system. Medical instrumentation and apparatus for sample processing by electrophoresis. Index nomenclature

GOST 4.389-85: Product-quality index system. Medical ultrasonic diagnostic instruments. Index nomenclature

GOST 4.485-87: Product-quality index system. Apparatus electrical high-voltage surgical. Index nomenclature

GOST R 22.8.04-96: Safety in emergencies. Technical washing means for people disinfection. Disinfection shower unit. General technical requirements

GOST R 51632-2000: Technical aids for disabled persons. General technical requirements and test methods

GOST R 51945-2002: Aspirators. General specifications

GOST R 52567-2006: Road ambulances. Technical requirements and test methods

MI 193-79: State system for ensuring uniformity of measurements. Method of checking electrogastrographs

MI 194-79: State system for ensuring uniformity of measurements. Method of testing amplifiers biopotentials

MI 195-79: State system for ensuring uniformity of measurements. Method of calibration of medical recorders

MI 197-79: Method of calibration of medical oscilloscopes

MI 2728-2002: State system for ensuring uniformity of measurements. The list of regulatory documents on security requirements. The order of their application in the normative documents of the ICE

MU 5980-91: Guidelines for measuring the concentration of dyes - gray C cuboles and hot pink G by thin layer chromatography in the working area air

MUK 4.1.025-95: Methods of control. Chemical factors. Measurement of concentrations of (meth) acrylic compounds in environmental objects. Methodical instructions

MUK 4.1.2228-07: Chromato-mass-spectrometric determination of the sum of steroid saponins Yuss Schidiger in water

MUK 4.1.3233-14: Measurement of mass concentrations of 2, 4-dichlorophenol and 2, 4, 6-trichlorophenol in the blood by capillary gas chromatography

MUK 4.1.3357-16: Measurement of the mass concentration of methyl tert-butyl ether in the blood by capillary gas chromatography

OMU 42-21-26-88: Departments of hyperbaric oxygenation, rules of operation and repair

OMU 42-21-27-88: Hyperbaric oxygenation devices. Operation and repair rules

OMU 42-21-35-91: Medical steam sterilizers. Operating rules and safety requirements when working on steam sterilizers

RD 153-34.0-03.504-00: Guidelines on Organization and Performance of Psychophysiological Examinations of Energy Facility Personnel

RD 50-707-91: Guidelines. Products of medical equipment. Requirements for reliability. Rules and methods for monitoring reliability indicators

RD 52.04.186-89: Part 1. Guidance on the control of air pollution. Pollution of the atmosphere in cities and other settlements. Main Geophysical Observatory. A.I.Voyeikova (MGO)

RD BGEI 36-01: Occupational safety requirements for the operation of topographic and geodetic techniques and methods for their control

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