GOST R 55953-2014
ГОСТ Р 55953-2014
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Medical electrical equipment. Anaesthetic workstation. Technical requirements for public procurement
Изделия медицинские электрические. Аппараты ингаляционной анестезии. Технические требования для государственных закупок
Status: Not effective - Superseded. Registration information 1135-st dated 12/25/2018 (Rosstandart official website); IUS 3-2019
This standard establishes the main technical requirements for inhalation anesthesia devices (hereinafter referred to as anesthesiological complexes) and is intended for use by authorized persons of state customers in the preparation of technical tasks for tender documentation for the procurement of high-tech medical equipment (WMO) for state needs ([1], [2 ] and [3]). This standard applies to bidding for public procurement of WMO for the provision of high-tech medical care ([4] and [5]). This standard does not apply to non-public procurement of medical equipment. The standard establishes the technical requirements for anesthesia complexes in general, as well as for the following components of anesthesia complexes, which can be considered as basic components and supplied separately for further use with other or already existing components for the implementation of the anesthesiology complex of the declared configuration taking into account the specific requirements of a particular medical institution
Настоящий стандарт устанавливает основные технические требования к аппаратам ингаляционной анестезии (далее - анестезиологические комплексы) 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 распространяется на торги по государственным закупкам ВМО для оказания высокотехнологичной медицинской помощи ([4] и [5]). Настоящий стандарт не распространяется на негосударственные закупки медицинского оборудования. Стандарт устанавливает технические требования к анестезиологическим комплексам в целом, а также к следующим компонентам анестезиологических комплексов, которые могут считаться основными компонентами и поставляться в отдельности для дальнейшего использования с другими или уже имеющимися компонентами для реализации анестезиологического комплекса заявленной конфигурации с учетом специфических требований конкретного лечебного учреждения
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
2/28/2014
SKU: RUSS72883
The Product is Contained in the Following Classifiers:
ISO classifier »
11 HEALTH »
11.040 Medical equipment »
11.040.10 Anesthesia, respiratory and resuscitation apparatus »
National standards »
11 HEALTH »
11.040 Medical equipment »
11.040.10 Anesthesia, respiratory and resuscitation apparatus »
National Standards for KGS (State Standards Classification) »
Latest edition »
R Health. Sanitation and hygiene items »
R2 Equipment and tools of medical institutions »
R22 Devices, apparatus, accessories and equipment used in surgery, in dental and autopsy practice. Anesthetic and artificial respiration devices »
The Document is Replaced With:
GOST R 55953-2018: Medical Products. Anesthesia-respiratory apparatus. Technical Requirements for Public Procurement
The Document References:
GOST 15150-69: Machines, instruments and other industrial products. Modifications for different climatic regions. Categories, operating, storage and transportation conditions as to environment climatic aspects influence
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 50444-92: Medical instruments, apparatus and equipment. General specifications
GOST R 52792-2007: Low-pressure hose assemblies for use with medical gases. Technical requirements and test methods
GOST R 52795-2007: Roasted ground coffee. Determination of moisture content. Karl Fischer method
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 ISO 15223-1-2010: Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1. General requirements
GOST R ISO 80601-2-13-2013: Medical electrical equipment. Part 2-13. Particular requirements for the basic safety and essential performance of anaesthetic workstations
The Document is Referenced By:
GOST R 56325-2014: Medical electrical equipment. Respiratory gas monitors. Technical requirements for governmental purchases
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