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GOST 30324.0-95

ГОСТ 30324.0-95

Medical electrical equipment. Part 1. General safety requirements

Изделия медицинские электрические. Часть 1. Общие требования безопасности

Status: Effective - Introduced for the first time

This standard applies to the safety of MEDICAL ELECTRICAL PRODUCTS. Since this standard is mainly related to safety, it contains some requirements for reliable operation, if it is related to safety.

Настоящий стандарт распространяется на безопасность МЕДИЦИНСКИХ ЭЛЕКТРИЧЕСКИХ ИЗДЕЛИЙ. Так как настоящий стандарт относится в основном к безопасности, он содержит некоторые требования, касающиеся надежной работы, если это связано с безопасностью

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Format: Electronic (pdf/doc)

Approved: Gosstandart of Russia, 3/12/1996

SKU: RUSS74136

Price: $2,186.00

English keywords: medical equipment; products; reliability;


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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 »

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 » R0 General rules and regulations on health » R07 Safety Instructions »

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


The Document References:

GOST 12.2.006-87: Safety of the electronic mains-connected and similar devices intended for everyday and similar general-purpose use

GOST 14254-96: Degrees of protection provided by enclosures (IP Code)

GOST 16504-81: The state system of testing products. Product test and quality inspection. General terms and definitions

GOST 18826-73: Drinking water. Methods for determination of nitrates content

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

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

GOST 21991-89: Electrotechnical equipment. Standard directions of movement for actuators which control the operation of electrical apparatus

GOST 22782.0-81: Explosion-proof electrical equipment

GOST 22782.1-77: Explosion-protective electrical equipment

GOST 22782.2-77: Explosion-proof electric equipment

GOST 22782.4-78: Explosion-proof electrical apparatus. Pressurized enclosure. Technical requirements and methods of testing

GOST 25516-82: The switches for electric appliances. General safety requirements and methods of tests

GOST 26104-89: Electronic measurement instruments

GOST 26140-84: Medical x-ray units

GOST 26413.0-85: Power cords

GOST 27473-87: Method for determining the comparative and the proof tracking indices of solid insulating materials under moist conditions

GOST 27570.0-87: Safety of household appliances and similar devices

GOST 28190-89: Appliance couplers for household and similar general purposes. Requirements and methods of tests

GOST 28200-89: Basic environmental testing procedures. Part 2. Tests. Test B: Dry heat

GOST 28380-89: Solderless connections. Part 1. Solderless wrapped connections. General requirements, test methods and practical guidance

GOST 28779-90: Solid electrical insulating materials. Methods of test for the determination of the flammability when exposed to an igniting source

GOST 8865-93: Electrical insulation system. Thermal evalution and classification

GOST R 50819-95: Humidifiers for medical use. Safety requirements

GOST R IEC 878-95: Graphical symbols electrical equipment in medical practice

GOST R ISO 8185-99: Humidifiers for medical use. Technical requirements and test methods

The Document is Referenced By:

GOST 12.2.091-2002: Safety requirements for electrical equipment for measurement, control and laboratory use. Part 1. General requirements

GOST 12.2.091-2012: Safety requirements for electrical equipment for measurement, control and laboratory use. Part 1. General requirements

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

GOST 30324.1.2-2012: Medical electrical equipment. Part 1-2. General requirements for safety. Electromagnetic compatibility. Requirements and test methods

GOST 30324.10-95: Medical electrical equipment. Part 2. Particular requirements for the safety of nerve and muscle stimulators

GOST 30324.11-2002: Medical electrical equipment. Part 2. Particular requirements for the safety of gamma beam therapy equipment

GOST 30324.12-95: Medical electrical equipment. Part 2. Particular requirements for the safety of lung ventilators for medical use

GOST 30324.13-95: Medical electrical equipment. Part 2. Particular requirements for the safety of anaesthetic machines

GOST 30324.14-95: Medical electrical equipment. Part 2. Particular requirements for the safety of electroconvulsive therapy equipment

GOST 30324.2.29-2012: Medical electrical equipment. Part 2-29. Particular requirements for the safety of radiotherapy simulators (imitators)

GOST 30324.2.38-2012: Medical electrical equipment. Part 2-38. Particular requirements for the safety of electrically operated hospital beds

GOST 30324.2.47-2012: Medical electrical equipment. Part 2-47. Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

GOST 30324.2.49-2012: Medical electrical equipment. Part 2-49. Particular requirements for the safety of multifunction patient monitoring equipment

GOST 30324.2.9-2012: Medical electrical equipment. Part 2-9. Particular requirements for the safety of patient contact dosimeters used in radiotherapy with electrically connected radiation detectors

GOST 30324.21-2002: Medical electrical equipment. Part 2. Particular requirements for the safety of infant radiant warmers

GOST 30324.27-95: Medical electrical equipment. Part 2. Particular requirements for safety of electrocardiographic monitoring equipment

GOST 30324.28-2002: Medical electrical equipment. Part 2. Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

GOST 30324.30-2002: Medical electrical equipment. Part 2. Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment

GOST 30324.31-2002: Medical electrical equipment. Part 2. Particular requirements for the safety of external cardiac pacemakers with internal power source

GOST 30324.32-2002: Medical electrical equipment. Part 2. Particular requirements for the safety of associated equipment of X-ray equipment

GOST 30324.3-95: Medical electrical equipment. Part 2. Particular requirements for the safety of short-wave therapy equipment

GOST 30324.4-95: Medical electrical equipment. Part 2. Particular requirements for the safety of defibrillators and defibrillators-monitors

GOST 31056-2002: Oxygen concentrators for medical use. Safety requirements

GOST 31212-2003: Implantable cardiac pacemakers. General specifications and basic test methods

GOST 31511.2-2012: Lung ventilators for medical use. Part 2. Particular requirements for home care ventilators

GOST 31512-2012: Medical monoplaced fixed barochambers. General technical requirements

GOST 31513-2012: Oxygen monitors for monitoring patient breathing mixtures. Safety requirements

GOST 31515.1-2012: Non-invasive sphygmomanometers (measuring devices of arterial pressure). Part 1. General requirements

GOST 31515.3-2012: Non-invasive sphygmomanometers (measuring devices of arterial pressure). Part 3. Supplementary requirements for electro-mechanical blood pressure measuring systems

GOST 31518.1-2012: Anaesthetic and respiratory equipment. Conical connectors. Part 1. Cones and sockets

GOST 31582-2012: Implantable electrodes for cardiac pacemakers. Technical requirements and test methods

GOST 31590.1-2012: Ophtnalmic instruments. Part 1. General requirements applicable to all ophthalmic instruments and test methods

GOST 34243-2017: Telemedicine systems. General safety requirements with regard to the main functional characteristics of mobile telemedicine laboratory and diagnostic systems

GOST 34244-2017: Telemedicine systems. General safety requirements, taking into account the basic functional characteristics of fixed telemedicine consultative and diagnostic centers

GOST IEC 60522-2011: X-ray tube assemblies. Methods for determination of the permanent filtration

GOST IEC 60580-2011: Medical electrical equipment. Dose area product meters

GOST IEC 60601-1-1-2011: Medical electrical equipment. Part 1-1. General requirements for safety. Safety requirements for medical electrical systems

GOST IEC 60601-1-6-2011: Medical electrical equipment. Part 1-6. General requirements for safety. Usability

GOST IEC 60601-1-8-2011: Medical electrical equipment. Part 1-8. General requirements for safety. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical

GOST IEC 60601-2-1-2011: Medical electrical equipment. Part 2-1. Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV

GOST IEC 60601-2-13-2011: Medical electrical equipment. Part 2. Particular requirements for the safety of anaesthetic workstations

GOST IEC 60601-2-2-2011: Medical electrical equipment. Part 2-2. Particular requirements for the safety of high frequency surgical equipment

GOST IEC 60601-2-43-2011: Medical electrical equipment. Part 2-43. Particular requirements for the safety of X-ray equipment for interventional procedures

GOST IEC 60601-2-44-2011: Medical electrical equipment - Part 2-44. Particular requirements for the safety of X-ray equipment for computed tomography

GOST IEC 60601-2-45-2011: Medical electrical equipment. Part 2-45. Particular requirements for safety of mammographic X-ray equipment and mammographic stereotactic devices

GOST IEC 60601-2-51-2011: Medical electrical equipment. Part 2-51. Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

GOST IEC 60601-2-7-2011: Medical electrical equipment. Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

GOST IEC 60976-2011: Medical electrical equipment. Medical electron accelerators. Functional characteristics

GOST IEC 61217-2012: Radiotherapy equipment. Coordinates, movements and scales

GOST IEC 61558-2-16-2015: Safety of power transformers, power supplies, reactors and similar products. Part 2-16. Additional requirements and test methods for switching power supplies and transformers for switching power supplies

GOST IEC/TS 61170-2011: Radiotherapy simulators. Guidelines for functional performance characteristics

GOST ISO 10079-1-2012: Medical suction equipment. Part 1. Electrically powered suction equipment. General technical requirements and test methods

GOST ISO 10079-3-2012: Medical suction equipment. Part 3. Suction equipment powered from a vacuum or pressure source. General technical requirements and test methods

GOST ISO 10342-2011: Eye refractometers. Technical requirements and test methods

GOST ISO 10343-2011: Ophthalmometers. Technical requirements and test methods

GOST ISO 15606-2011: Dental hand pieces. Air-powered scalers and scaler tips

GOST ISO 5358-2012: Anaesthetic machines. General technical requirements

GOST ISO 5362-2022: Breathing bags used in anesthesia

GOST ISO 7785-1-2011: Dental handpieces. Part 1. High-speed air turbine handpieces

GOST ISO 7785-2-2011: Dental handpieces. Part 2. Straight and geared angle handpieces

GOST ISO 8185-2012: Humidifiers for medical use. Technical requirements and test methods

GOST ISO 8835-3-2012: Inhalational anaesthesia systems. Part 3. Anaesthetic gas scavenging systems. Transfer and receiving systems

GOST ISO 9918-2012: Capnometers for use with humans. Requirements

GOST ISO 9919-2011: Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeters

GOST R 15.013-94: System of product development and launching into manufacture. Medical products

GOST R 50267.0.3-99: Medical electrical equipment. Part 1. General requirements for safety. 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment

GOST R 50267.0.4-99: Medical electrical equipment. Part 1. General requirements safety. 4. Collateral standard. Programmable medical electrical systems

GOST R 50267.11-99: Medical electrical equipment. Part 2. Particular requirements for the safety of gamma beam therapy equipment

GOST R 50267.16-2003: Medical electrical equipment. Part 2. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

GOST R 50267.18-94: Medical electrical equipment. Part 2. Particular requirements for the safety of endoscopic equipment

GOST R 50267.1-99: Medical electrical equipment. Part 2. Particular requirements for the safety of electron accelerators in the range 1 to 50 MeV

GOST R 50267.21-96: Medical electrical equipment. Part 2. Particular requirements for the safety of infant radiant warmers

GOST R 50267.22-2002: Medical electrical equipment. Part 2. Particular requirements for the safety of diagnostic and therapeutic laser equipment

GOST R 50267.29-99: Medical electrical equipment. Part 2. Particular requirements for the safety of radiotherapy simulators (imitators)

GOST R 50267.30-99: Medical electrical equipment. Part 2. Particular requirements for safety of automatic cycling indirect blood pressure monitoring equipment

GOST R 50267.31-99: Medical electrical equipment. Part 2. Particular requirement for the safety of external cardiac pacemakers with internal power source

GOST R 50267.32-99: Medical electrical equipment. Part 2. Particular requirements for the safety of associated equipment of X-ray equipment

GOST R 50267.33-99: Medical electrical equipment. Part 2. Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

GOST R 50267.38-99: Medical electrical equipment. Part 2. Particular requirements for the safety of electrically operated hospital beds

GOST R 50267.41-2001: Medical electrical equipment. Part 2. Particular requirements for the safety of luminaires for diagnosis and surgical luminaires

GOST R 50267.43-2002: Medical electrical equipment. Part 2. Particular requirements for the safety of X-ray equipment for interventional procedures

GOST R 50267.45-99: Medical electrical equipment. Part 2. Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices

GOST R 50267.47-2004: Medical electrical equipment. Part 2. Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

GOST R 50267.49-2004: Medical electrical equipment. Part 2. Particular requirements for the safety of multifunction patient monitoring equipment

GOST R 50444-2020: Medical devices, apparatus and equipment. General technical requirements

GOST R 51316-99: Medical monoplaced fixed barochambers. General technical requirements

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

GOST R 51746-2001: Evaluation and routine testing in medical imaging departments. Part 1. General requirements

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

GOST R 51959.3-2002: Non-invasive sphygmomanometers (measuring devices of arterial pressure). Part 3. Supplementary requirements for electro-mechanical blood pressure measuring systems

GOST R 52161.1-2004: Safety of household and similar electrical appliances. Part 1. General requirements

GOST R 52161.2.15-2006: Safety of household and similar electrical appliances. Part 2.15. Particular requirements for appliances for heating liquids

GOST R 52161.2.17-2009: Safety of household and similar electrical appliances. Part 2.17. Particular requirements for blankets, pads, clothing and similar flexible heating appliances

GOST R 52161.2.23-2007: Safety of household and similar electrical appliances. Part 2.23. Particular requirements for skin or hair care devices

GOST R 52161.2.25-2007: Safety of household and similar electrical appliances. Part 2.25. Particular requirements for microwave ovens, including combination microwave ovens

GOST R 52161.2.8-2005: Safety of household and similar electrical appliances. Part 2.8. Particular requirements for shavers, hair clippers and similar appliances

GOST R 52161.2.98-2009: Safety of household and similar electrical appliances. Part 2.98. Particular requirements for humidifiers

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

GOST R 52566-2006: Oxygen monitors for monitoring patient breathing mixtures. Safety requirements

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

GOST R 56168-2014: Medical electrical equipment. Operation microscope. Specifications for governmental purchase

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 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 58698-2019: Protection against electric shock. General Provisions for Electrical Installations and Electrical Equipment

GOST R 8.665-2009: State system for ensuring the uniformity of measurements. Photo-electric luхmeter and brightness meter. Methods of verification

GOST R IEC 335-1-94: Safety of household and similar electrical appliances. General requirements and test methods

GOST R IEC 598-2-25-98: Luminaires. Part 2. Particular requirements. Section 25. Luminaries for use in clinical areas of hospitals and health care buildings

GOST R IEC 60118-14-2003: Programmable hearing aids. Specification of a digital interface devices. Dimensions of electrical connectors

GOST R IEC 60335-2-15-98: Safety of household and similar electrical appliances. Particular requirements for appliances for heating liquids and test methods

GOST R IEC 60335-2-76-2001: Safety of household and similar electrical appliances. Particular requirements for electric fence energizers and test methods

GOST R IEC 60335-2-88-2001: Safety of household and similar electrical appliances. Particular requirements for humidifiers intended for use with heaters, ventilators and air-conditioning systems and test methods

GOST R IEC 60335-2-8-98: Safety of household and similar electrical appliances. Particular requirements for shavers, hair clippers and similar appliances and test methods

GOST R IEC 60522-2001: X-ray tube assemblies. Methods for determination of the permanent filtration

GOST R IEC 60580-2006: Medical electrical equipment. Dose area product meters

GOST R IEC 60601-1-6-2007: Medical electrical equipment. Part 1-6. General requirements for safety. Usability

GOST R IEC 60601-2-1-2009: Medical electrical equipment. Part 2-1. Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV

GOST R IEC 60601-2-13-2001: Medical electrical equipment. Part 2. Particular requirements for the safety of anaesthetic workstations

GOST R IEC 60601-2-2-2006: Medical electrical equipment. Part 2. Particular requirements for the safety of high frequency surgical equipment

GOST R IEC 60601-2-44-2005: Medical electrical equipment. Part 2-44. Particular requirements for the safety of X-ray equipment for computed tomography

GOST R IEC 60601-2-7-2006: Medical electrical equipment. Part 2-7. Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

GOST R IEC 60976-99: Medical electrical equipment. Medical electron accelerators. Functional characteristics

GOST R IEC 60977-99: Medical electrical equipment. Medical electron accelerators in the range of 1 to 50 MeV. Guidelines for functional performance characteristics

GOST R IEC 61170-99: Radiotherapy simulators (imitators). Guidelines for functional performance characteristics

GOST R IEC 61217-99: Radiotherapy equipment. Coordinates, movements and scales

GOST R IEC 61223-3-1-2001: Evaluation and routine testing in medical imaging departments. Part 3-1. Imaging performance of X-ray equipment for radiographic and radioscopic systems. Acceptance tests

GOST R IEC 61223-3-4-2001: Evaluation and routine testing in medical imaging departments. Part 3-4. Imaging performance of dental X-ray equipment. Acceptance tests

GOST R IEC 61953-2001: Diagnostic X-ray imaging equipment. Characteristics of mammographic anti-scatter grids

GOST R ISO 10079.1-99: Medical suction equipment. Part 1. Electrically powered suction equipment. General technical requirements and test methods

GOST R ISO 10079.3-99: Medical suction equipment. Part 3. Suction equipment powered from vacuum or pressure source

GOST R ISO 10342-2008: Eye refractometers. Technical requirements and test methods

GOST R ISO 10343-2008: Ophthalmometers. Technical requirements and test methods

GOST R ISO 10535-2010: Hoists for the transfer of disabled persons. Requirements and test methods

GOST R ISO 10651.1-99: Lung ventilators for medical use. Part 1. Technical requirements

GOST R ISO 10651.3-99: Lung ventilators. Part 3. Particular requirements for emergency and transport ventilators

GOST R ISO 13091-1-2008: Vibration. Vibrotactile perception thresholds for the assessment of nerve disfunction. Part 1. Methods of measurements at the fingertips

GOST R ISO 14971-2006: Medical devices. Application of risk management to medical devices

GOST R ISO 15223-2002: Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied

GOST R ISO 15606-2006: Dental handpieces. Air-powered scalers and scaler tips

GOST R ISO 5358-99: Anaesthetic machines. General technical requirements

GOST R ISO 7785-2-2006: Dental handpieces. Part 2. Straight and geared angle handpieces

GOST R ISO 8185-99: Humidifiers for medical use. Technical requirements and test methods

GOST R ISO 8835.3-99: Inhalational anaesthesia systems. Part 3. Anaesthetic gas scavenging systems. Transfer and receiving systems

GOST R ISO 9703.3-99: Anaesthesia and respiratory care alarm signals. Part 3. Guidance on application of alarms

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 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

R 50.1.043-2003: Information supplied by the manufacturer with medical devices

R 50.2.064-2009: State system for ensuring the uniformity of measurements. Spectrophotometrs for medical laboratories. Methods for verification

RD 50-717-92: Guidelines. Guidelines for the safe operation of electro-medical products for administration, maintenance and medical personnel of medical institutions

SP 319.1325800.2017: Buildings and premises of medikal institutions. The rules of operation

STB IEC 60598-2-25-2002: Lighting fixtures. Part 2. Particular requirements. Section 25. Lighting fixtures for using in clinical areas in the hospitals and other medical institutions

STB IEC 60601-1-2-2006: Electric medical products. Part 1-2. General safety requirements. Electromagnetic compatibility. Requirements and test methods

STB IEC 61140-2007: Protection against electric-shock hazard. General safety provisions for installations and equipment

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