GOST R IEC 60601-1-2010
ГОСТ Р МЭК 60601-1-2010
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Medical electrical equipment. Part 1. General requirements for basic safety and essential performance (IEC 60601-1:1988, IEC 60601-2-17(2004))
Изделия медицинские электрические. Часть 1. Общие требования безопасности с учетом основных функциональных характеристик
Status: Effective - Introduced for the first time
This standard applies to general safety requirements, taking into account the basic functional characteristics of medical electrical products and medical electrical systems. This standard can also be applied to products used to compensate or alleviate illness, injury, or disability. This standard does not apply to medical gas supply systems in accordance with ISO 7396-1.
Настоящий стандарт распространяется на общие требования безопасности с учетом основных функциональных характеристик к изделиям медицинским электрическим и системам медицинским электрическим. Настоящий стандарт может также применяться к изделиям, используемым для компенсации или облегчения заболеваний, травм или утраты трудоспособности. Настоящий стандарт не распространяется на системы подачи медицинских газов по ИСО 7396-1
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
11/23/2010
SKU: RUSS74403
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 OKSTU »
MEDICAL EQUIPMENT »
Rules for acceptance, use, operation and repair. Safety engineering »
The Document is Replaced With:
GOST R IEC 60601-1-2022: Medical electrical products. Part 1. General safety requirements with regard to the main functional characteristics
The Document References:
GOST 11478-88: Electronic consumer equipment. Norms and methods of climatic and environmental mechanical testing procedure
GOST 14254-96: Degrees of protection provided by enclosures (IP Code)
GOST 27473-87: Method for determining the comparative and the proof tracking indices of solid insulating materials under moist conditions
GOST 28200-89: Basic environmental testing procedures. Part 2. Tests. Test B: Dry heat
GOST 28312-89: Radioelectronic equipment, professional. Conventional graphic designations
GOST 30331.3-95: Electrical installations of buildings. Part 4. Protection for safety. Protection against electric shock
GOST 30457-97: Acoustics. Determination of sound power levels of noise sources using sound intensity. Measurement at discrete points. Engineering method
GOST 7396.1-89: Plugs and socket-outlets for domestic and similar general use
GOST R 50267.0.2-2005: Medical electrical equipment. Part 1-2. General requirements for safety. Electromagnetic compatibility. Requirements and test methods
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 51322.1-99: Plugs and socket-outlets for household and similar purposes. Part 1. Requirements and methods of tests
GOST R 51325.1-99: Appliance couplers for household and similar general purposes. Requirements and methods of tests
GOST R 51362-99: Dry-cleaning machines. Graphical symbols for use on equipment
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
GOST R 52161.1-2004: Safety of household and similar electrical appliances. Part 1. General requirements
GOST R 52350.2-2006: Electrical apparatus for explosive gas atmospheres. Part 2. Pressurized enclosures 'р'
GOST R 52350.5-2006: Electrical apparatus for explosive gas atmospheres. Part 5. Powder filling 'q'
GOST R 52350.6-2006: Electrical apparatus for explosive gas atmospheres. Part 6. Oil-immersion 'o'
GOST R IEC 60065-2005: Audio, video and similar electronic apparatus. Safety requirements
GOST R IEC 60079-0-2007: Explosive atmospheres. Part 0. Equipment. General requirements
GOST R IEC 60127-1-2005: Miniature fuses. Part 1. Definitions for miniature fuses and general requirements for miniature fuse-links
GOST R IEC 60227-1-99: Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V. General requirements
GOST R IEC 60245-1-2006: Rubber insulated cables for rated voltages up to and including 450/750 V. Part 1. General requirements
GOST R IEC 60252-1-2005: AC motor capacitors. Part 1. General. Performance, testing and rating. Safety requirements. Guide for installation and operation
GOST R IEC 60384-14-2004: Fixed capacitors for use in electronic equipment. Part 14. Sectional specification on fixed capacitors for electromagnetic interference suppression and connection to the supply mains
GOST R IEC 60447-2000: Man-machine interface. Actuating principles
GOST R IEC 60601-1-6-2007: Medical electrical equipment. Part 1-6. General requirements for safety. Usability
GOST R IEC 60601-1-8-2007: 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 systems
GOST R IEC 60730-1-2002: Automatic electrical controls for household and similar use. General requirements and test methods
GOST R IEC 60851-3-2002: Winding wires. Test methods. Part 3. Mechanical properties
GOST R IEC 60851-5-2002: Winding wires. Test methods. Part 5. Electrical properties
GOST R IEC 60851-6-2002: Winding wires. Test methods. Part 6. Thermal properties
GOST R IEC 60950-1-2005: Information technology equipment. Safety. Part 1. General requirements
GOST R IEC 61058.1-2000: Switches for electrical appliances. Part 1. General requirements and test methods
GOST R IEC 878-95: Graphical symbols electrical equipment in medical practice
GOST R ISO 11134-2000: Sterilization of health care products. Requirements for validation and routine control. Industrial moist heat sterilization
GOST R ISO 11135-2000: Medical devices. Validation and routine control of ethylene oxide sterilization
GOST R ISO 11137-2000: Sterilization of health care products. Requirements for validation and routine control. Radiation sterilization
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
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