GOST R 56279-2014
ГОСТ Р 56279-2014
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Medical electrical equipment. Endoscopic racks. Specifications for governmental purchase
Изделия медицинские электрические. Стойки эндоскопические. Технические требования для государственных закупок
Status: Effective - Introduced for the first time. IUS 6-2015
This standard establishes general requirements for the preparation of public procurement of medical equipment (MO): endoscopic racks (hereinafter referred to as EC). This standard is a private standard in relation to GOST R 55719. The standard applies to bidding for public and municipal procurement of municipalities for medical care. The standard does not apply to non-public procurement MO. This standard applies to endoscopic stands designed to equip endoscopic diagnostic units for the purpose of carrying out medical
Настоящий стандарт устанавливает общие требования к подготовке проведения государственных закупок медицинского оборудования (МО): эндоскопических стоек (далее-ЭС). Настоящий стандарт является частным стандартом по отношению к ГОСТ Р 55719. Стандарт распространяется на торги по государственным и муниципальным закупкам МО для оказания медицинской помощи. Стандарт не распространяется на негосударственные закупки МО. Настоящий стандарт распространяется на эндоскопические стойки, предназначенные для оснащения эндоскопических диагностических отделений с целью проведения лечебно/оперативных вмешательств через эндоскоп с помощью специальных инструментов, которые проводятся через инструментальный канал. Стандарт устанавливает технические требования к ним для государственных закупок. Требования настоящего стандарта не распространяются на стойки операционные нейрохирургические с набором эндоскопов
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
11/26/2014
SKU: RUSS287750
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 »
3 Activities of testing laboratories »
3.2 Technical equipment of testing laboratories »
3.2.2 Measuring instruments and test equipment »
3.2.2.5 Optical and optical-mechanical devices, light and electron microscopes »
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 »
P Measuring devices. Automation and computing facilities »
P4 Optical and optomechanical devices, light and electron microscopes »
P46 Optical devices for correction, protection and research of eye »
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 20790-93: Medical instruments, apparatus and equipment. General specifications
GOST 30324.0-95: Medical electrical equipment. Part 1. General safety requirements
GOST ISO 14971-2011: Medical devices. Application of risk management to medical devices
GOST R 50267.0.2-2005: Medical electrical equipment. Part 1-2. General requirements for safety. Electromagnetic compatibility. Requirements and test methods
GOST R 50267.0-92: Medical electrical equipment. Part 1. General safety requirements
GOST R 50444-92: Medical instruments, apparatus and equipment. General specifications
GOST R 51318.11-99: Electromagnetic compatibility of technical equipment. Radio disturbance from industrial, scientific, medical and domestic (ISMD) radio-frequency equipment. Limits and test methods
GOST R 51609-2000: Medical products. Classification in accordance with potential risk of using. General requirements
GOST R 53469-2009: Optics and optical instruments. Medical endoscopes and endotherapy devices. Part 1. General requirements
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 60601-2-18-2014: Medical electrical equipment. Part 2-18. Particular requirements for the basic safety and essential performance of endoscopic equipment
GOST R ISO 13485-2004: Medical devices. Quality management systems. System requirements for regulatory purposes
GOST R ISO 13683-2000: Sterilization of health care products. Requirements for validation and routine control of moist heat sterilization in health care facilities
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 8600-6-2012: Optics and optical instruments. Medical endoscopes and endotherapy devices. Part 6. Terms and definitions
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