GOST R 50267.0.2-2005
ГОСТ Р 50267.0.2-2005
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Medical electrical equipment. Part 1-2. General requirements for safety. Electromagnetic compatibility. Requirements and test methods
Изделия медицинские электрические. Часть 1-2. Общие требования безопасности. Электромагнитная совместимость. Требования и методы испытаний
Status: Not effective - Canceled. Information about the registration of 619-st from 11/01/2012 (the official website of Rosstandart). Use GOST 30324.1.2-2012 (IEC 60601-1-2: 2001) (IUS 12-2013)
This standard is used to ensure the electromagnetic compatibility of medical electrical products and medical electrical systems. This standard establishes the requirements for products and systems for ensuring electromagnetic compatibility and their test methods and serves as the basis for setting the requirements for electromagnetic compatibility and test methods in private standards applicable to medical products of a specific type.
Настоящий стандарт применяют для обеспечения электромагнитной совместимости медицинских электрических изделий и медицинских электрических систем. Настоящий стандарт устанавливает требования к изделиям и системам по обеспечению электромагнитной совместимости и методы их испытаний и служит основой для установления требований электромагнитной совместимости и методов испытаний в частных стандартах, распространяющихся на медицинские изделия конкретного вида
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
12/30/2005
SKU: RUSS73725
The Product is Contained in the Following Classifiers:
Evidence base (TR CU, Technical Regulation of the Customs Union) »
020/2011 TR CU. Electromagnetic compatibility of technical means »
Regulations and standards (to ТР ТС ТС 020/2011) »
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 »
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 »
E Electronic engineering, electronics and communications »
E0 General rules and regulations for electronic engineering, electronics and communications »
E02 Design and calculation norms »
As a Replacement Of:
GOST R 50267.0.2-95: Medical electrical equipment. Part 1. General requirements for safety. 2. Electromagnetic compatibility. Requirements and tests
The Document is Referenced By:
GOST R 50267.12-2006: Medical electrical equipment. Part 2-12. Particular requirements for safety of lung ventilators for critical care ventilation
GOST R 51632-2000: Technical aids for disabled persons. General technical requirements and test methods
GOST R 51935-2002: Steam large sterilizers. General technical requirements and test methods
GOST R 51945-2002: Aspirators. General specifications
GOST R 52459.27-2009: Electromagnetic compatibility of technical equipment. Radio communication equipment. Part 27. Specific requirements for ultra-low power active medical implants and related peripheral devices
GOST R 52459.31-2009: Electromagnetic compatibility of technical equipment. Radio communication equipment. Part 31. Specific requirements for equipment in 9 kHz to 315 kHz band for ultra-low power active medical implants and related peripheral devices
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 55718-2013: Medical electrical equipment. Angiography X-ray equipment. Technical requirements for governmental purchases
GOST R 55771-2013: Medical electrical equipment. Angiography X-ray equipment. Technical requirements for governmental purchases
GOST R 55772-2013: Medical electrical equipment. X-ray equipment for digital radiography and radioscopy. Technical requirements for governmental purchases
GOST R 55773-2013: Medical electrical equipment. X-ray equipment for interventional procedures. Technical requirements for governmental purchases
GOST R 55952-2014: Medical electrical equipment. Electrocardiographic monitoring equipment. Technical requirements for public procurement
GOST R 55953-2014: Medical electrical equipment. Anaesthetic workstation. Technical requirements for public procurement
GOST R 55954-2014: Medical electrical equipment. Lung ventilators. Technical requirements for public procurement
GOST R 56278-2014: Medical electrical equipment. Videoendoskopic complexes with installations for ultrasonic and fluorescence endoscopy. Specifications for governmental purchase
GOST R 56279-2014: Medical electrical equipment. Endoscopic racks. Specifications for governmental purchase
GOST R 56280-2014: Medical electrical equipment. Neurosurgical operating racks with a set of endoscopes. Specifications for governmental purchase
GOST R 56609-2015: Medical electrical equipment. Digital simulators (imitators) with tomographic join for stereotacsis navigators of radiotherapy
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 60601-2-1-2009: 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 60601-2-33-2009: Medical electrical equipment. Part 2-33. Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
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 60601-2-51-2008: Medical electrical equipment. Part 2-51. Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
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 62083-2013: Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems
GOST R IEC 62274-2013: Medical electrical equipment. Safety of radiotherapy record and verify systems
GOST R ISO 10535-2010: Hoists for the transfer of disabled persons. Requirements and test methods
GOST R ISO 22523-2007: External limb prostheses and external orthoses. Requirements and test methods
GOST R ISO/IEC 18000-7-2012: Information technology. Radio frequency identification for item management. Part 7. Parameters for active air interface communications at 433 MHz
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