GOST R 55952-2014
ГОСТ Р 55952-2014
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Medical electrical equipment. Electrocardiographic monitoring equipment. Technical requirements for public procurement
Изделия медицинские электрические. Монитор электрокардиографический. Технические требования для государственных закупок
Status: Effective - Introduced for the first time. IUS 12-2014
This standard establishes the main technical requirements for electrocardiographic monitors and is intended for use by authorized persons of state customers in the preparation of technical specifications for tender documentation for the procurement of high-tech medical equipment (WMO) for state needs ([1], [2] and [3]). This standard establishes technical requirements for public procurement. This standard applies to bidding for public procurement of WMO for the provision of high-tech medical care (VMP) ([4] and [5]). This standard does not apply to non-public procurement of medical equipment. This standard establishes technical requirements for electrocardiographic monitors and applies to electrocardiographic monitors used in hospitals as well as outside hospitals, for example, in ambulance cars or in air transport
Настоящий стандарт устанавливает основные технические требования к электрокардиографическим мониторам и предназначен для применения уполномоченными лицами государственных заказчиков при составлении технических заданий для конкурсной документации при проведении закупок высокотехнологичного медицинского оборудования (ВМО) для государственных нужд ([1], [2] и [3]). Настоящий стандарт устанавливает технические требования для государственных закупок. Настоящий стандарт распространяется на торги по государственным закупкам ВМО для оказания высокотехнологичной медицинской помощи (ВМП) ([4] и [5]). Настоящий стандарт не распространяется на негосударственные закупки медицинского оборудования. Настоящий стандарт устанавливает технические требования к электрокардиографическим мониторам и распространяется на электрокардиографические мониторы, используемые в стационарах, а также за пределами стационаров, например, в машинах скорой помощи или в воздушном транспорте
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
2/28/2014
SKU: RUSS68067
The Product is Contained in the Following Classifiers:
ISO classifier »
11 HEALTH »
11.040 Medical equipment »
11.040.55 Diagnostic Equipment »
National standards »
11 HEALTH »
11.040 Medical equipment »
11.040.55 Diagnostic Equipment »
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 »
The Document References:
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 R 50267.0.2-2005: Medical electrical equipment. Part 1-2. General requirements for safety. Electromagnetic compatibility. Requirements and test methods
GOST R 55719-2013: Medical electrical equipment. Demands to the contents and veneering of technical projects for the competitive documentation at carrying out of the state purchases of the highly technological medical equipment
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 60601-2-27-2013: Medical electrical equipment. Part 2-27. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
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