GOST 30324.0-95
ГОСТ 30324.0-95
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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
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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