GOST R IEC 60601-1-2-2014

ГОСТ Р МЭК 60601-1-2-2014

Medical electrical equipment. Part 1-2. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests

Изделия медицинские электрические. Часть 1-2. Общие требования безопасности с учетом основных функциональных характеристик. Параллельный стандарт. Электромагнитная совместимость. Требования и испытания

Status: Effective - Introduced for the first time. IUS 10-2014

This standard applies to basic safety and the basic functional characteristics of medical electrical products and medical electrical systems, hereinafter referred to as “product me” and “me system”. This parallel standard applies to electromagnetic compatibility between products and systems.

Настоящий стандарт применяют к основной безопасности и основным функциональным характеристикам медицинских электрических изделий и медицинских электрических систем, в дальнейшем именуемых «ме изделия» и «ме системы». Настоящий параллельный стандарт применяют к электромагнитной совместимости ме изделий и ме систем

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Format: Electronic (pdf/doc)
Page Count: 109

Approved: Federal Agency for Technical Regulation and Metrology, 2/26/2014

SKU: RUSS74340

Price: $1,319.20




The Product is Contained in the Following Classifiers:

PromExpert » SECTION I. TECHNICAL REGULATION » V Testing and control » 4 Testing and control of products » 4.15 Testing and control of products of electronic, optical and electrical industry » 4.15.3 Medical equipment »

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 » 11.040.01 Medical equipment in general »

National standards » 11 HEALTH » 11.040 Medical equipment » 11.040.01 Medical equipment in general »

ISO classifier » 33 TELECOMMUNICATIONS. AUDIO AND VIDEO EQUIPMENT » 33.100 Electromagnetic Compatibility (EMS) » 33.100.10 Radiation »

National standards » 33 TELECOMMUNICATIONS. AUDIO AND VIDEO EQUIPMENT » 33.100 Electromagnetic Compatibility (EMS) » 33.100.10 Radiation »

ISO classifier » 33 TELECOMMUNICATIONS. AUDIO AND VIDEO EQUIPMENT » 33.100 Electromagnetic Compatibility (EMS) » 33.100.20 Security »

National standards » 33 TELECOMMUNICATIONS. AUDIO AND VIDEO EQUIPMENT » 33.100 Electromagnetic Compatibility (EMS) » 33.100.20 Security »


The Document References:

GOST 28312-89: Radioelectronic equipment, professional. Conventional graphic designations

GOST 30804.3.2-2013: Еlectromagnetic compatibility of technical equipment. Harmonic current emissions (equipment input current <= 16 A per phase). Limits and test methods

GOST 30804.3.3-2013: Еlectromagnetic compatibility of technical equipment. Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems. Equipment with rated current <= 16 A and not subject to conditional connection. Limits and test methods

GOST 30804.4.11-2013: Electromagnetic compatibility of technical equipment. Voltage dips, short interruptions and voltage variations immunity. Requirements and test methods

GOST 30804.4.2-2013: Electromagnetic compatibility of technical equipment. Immunity to electrostatic discharge. Requirements and test methods

GOST 30804.4.3-2013: Electromagnetic compatibility of technical equipment. Radiated, radio-frequency, electromagnetic field immunity. Requirements and test methods

GOST 30804.4.4-2013: Electromagnetic compatibility of technical equipment. Immunity to nanosecond impulsive disturbance. Requirements and test methods

GOST 30805.14.1-2013: Electromagnetic compatibility of technical equipment. Household appliances, electric tools and similar apparatus. Radio disturbance. Limits and methods of measurement

GOST 30805.16.1.2-2013: Electromagnetic compatibility of technical equipment. Specification for industrial radio disturbance and immunity measuring apparatus and methods. Part 1-2. Industial radio disturbance and immunity measuring apparatus. Conducted radio disturbance measuring and immunity test apparatus

GOST 30805.22-2013: Electromagnetic compatibility of technical equipment. Information technology equipment. Radio disturbance. Limits and methods of measurements

GOST R 51317.4.5-99: Electromagnetic compatibility of technical equipment. Microsecond high energy pulse disturbance immunity. Requirements and test methods

GOST R 51317.4.6-99: Electomagnetic compatibility of technical equipment. Immunity to conducted disturbance induced by radio-frequency fields. Requirements and test methods

GOST R 51318.11-2006: Electromagnetic compatibility of technical equipment. Industrial, scientific, medical and domestic (ISMD) high-frequency equipment. Radio disturbance. Limits and methods of measurement

GOST R 51318.15-99: Electromagnetic compatibility of technical equipment. Radio disturbance from electrical lighting and similar equipment. Limits and test methods

GOST R IEC 60601-1-2010: Medical electrical equipment. Part 1. General requirements for basic safety and essential performance (IEC 60601-1:1988, IEC 60601-2-17(2004))

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

The Document is Referenced By:

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GOST R 56326-2017: Medical equipment. Multifunction patient monitoring equipment. Technical requirements for governmental purchases

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GOST R 56328-2014: Medical equipment. Mobile complexes for medical purpose. General specifications and test methods

GOST R 56329-2014: Medical electrical equipment. Equipment for extracorporeally induced lithotripsy. Technical requirements for governmental purchases

GOST R 56330-2014: Medical equipment. Technical means of placement and transfer of patients in the prehospital. General specifications and test methods

GOST R 56330-2016: Medical equipment. Technical means of placement and transfer of patients in the prehospital. General technical requirements and test methods

GOST R 56331-2014: Medical electrical equipment. Medical diagnostic ultrasonic equipment. Technical requirements for governmental purchases

GOST R 56605-2015: Medical electrical equipment. Stereotaxis system for intraoperational control. Technical requirements for governmental purchases

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GOST R 56608-2015: Medical electrical equipment. Stereotaxis system for intraoperational control. Technical requirements for governmental purchases

GOST R 56610-2015: Medical electrical equipment. Magnetic-resonance tomography for extremities. Technical requirements for governmental purchases

GOST R 56611-2015: Medical electrical equipment. Stereotaxis system for extremities. Technical requirements for governmental purchases

GOST R 56612-2015: Medical electrical equipment. Stereotaxis system for intraoperational control. Technical requirements for governmental purchases

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GOST R 57081-2016: Medical electrical equipment. Universal Radiographic Digital Systems. Technical requirements for governmental purchases

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GOST R 57769-2017: Antidecubital mattresses and pillows. Types and basic parameters

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GOST R 58024-2017: Medical devices. Equipment for thermal disinfection/neutralization of medical waste. Dry hot air method. Technical requirements for governmental purchases

GOST R IEC 60601-2-24-2017: Medical electrical equipment. Part 2-24. Particular requirements for the basic safety and essential performance of infusion pumps and controllers

GOST R IEC 60601-2-47-2017: Medical electrical equipment. Part 2-47. Particular requirements for basic safety and essential performance of ambulatory electrocardiographic systems

GOST R IEC 60601-2-49-2018: Medical electrical equipment. Part 2-49. Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

GOST R IEC 60645-1-2017: Electroacoustics. Audiometric equipment. Part 1. Equipment for pure-tone and speech audiometry

GOST R ISO 11252-2016: Optics and photonics. Lasers and laser-related equipment. Laser device. Minimum requirements for documentation

GOST R ISO 14708-3-2016: Implants for surgery. Active Implantable medical devices. Part 3. Implantable neurostimulators

GOST R ISO 14708-4-2016: Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pumps

GOST R ISO 14708-7-2016: Implants for surgery. Active Implantable medical devices. Part 7. Particular requirements for cochlear implant systems

PNST 62-2015: Autonomous air disinfecting-cleaner. Specifications

GOST R 58447-2019: Lower limb prostheses with an external energy source. General technical requirements

GOST R 58453-2019: Medical Products. X-ray complexes for transmission and digital photographs. Essential specifications

GOST R 58936-2020: Optics and Photonics. Endoscopes and medical endotherapeutic devices. General technical requirements and test methods

GOST R IEC 60601-2-16-2016: Medical electrical equipment. Part 2-16. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration

GOST R IEC 60601-2-25-2016: Medical electrical equipment. Part 2-25. Particular requirements for the basic safety and essential performance of electrocardiographs

GOST R IEC 60601-2-36-2016: Medical electrical equipment. Part 2-36. Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

GOST R IEC 60601-2-41-2014: Medical electrical equipment. Part 2-41. Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

GOST R IEC 60601-2-45-2014: Medical electrical equipment. Part 2-45. Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

GOST R IEC 60601-2-46-2014: Medical electrical equipment. Part 2-46. Particular requirements for the basic safety and essential performance of operating tables

GOST R IEC 60601-2-65-2015: Medical electrical equipment. Part 2-65. Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

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