GOST R 56328-2014
ГОСТ Р 56328-2014
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Medical equipment. Mobile complexes for medical purpose. General specifications and test methods
Изделия медицинские. Подвижные (передвижные) комплексы медицинского назначения. Общие технические требования и методы испытаний
Status: Effective - Introduced for the first time. IUS 10-2015
This standard applies to mobile (mobile) medical systems (PCMN) intended for medical use (prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body, conducting medical research, restoring, replacing, changing anatomical structure or physiological functions of the body, preventing or terminating pregnancy). The standard establishes requirements for the design, operational characteristics, equipment of mobile PCMN and methods of their testing. The standard does not apply to ambulance cars according to GOST R 52567. The standard contains general requirements for medical devices used outside hospitals and clinics, where environmental conditions may differ from the conditions of use in inpatient medical institutions.
Настоящий стандарт распространяется на подвижные (передвижные) комплексы медицинского назначения (ПКМН), предназначенные для применения в медицинских целях (профилактики, диагностики, лечения и медицинской реабилитации заболеваний, мониторинга состояния организма человека, проведения медицинских исследований, восстановления, замещения, изменения анатомической структуры или физиологических функций организма, предотвращения или прерывания беременности). Стандарт устанавливает требования к конструкции, эксплуатационным характеристикам, оснащению подвижных ПКМН и методам их испытаний. Стандарт не распространяется на автомобили скорой медицинской помощи по ГОСТ Р 52567. Стандарт содержит общие требования к медицинским изделиям, применяемым вне больниц и клиник, где условия окружающей среды могут отличаться от условий применения в стационарных медицинских учреждениях
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
12/25/2014
SKU: RUSS287786
The Product is Contained in the Following Classifiers:
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 »
11 HEALTH »
11.160 First Aid »
National standards »
11 HEALTH »
11.160 First Aid »
The Document References:
Federal Law 323-FZ: On the basics of protecting the health of citizens in the Russian Federation
GOST 11109-90: Domestic cotton gauze. General specifications
GOST 12.1.004-91: Fire safety. General requirements
GOST 12.1.005-88: General sanitary requirements for working zone air
GOST 12.1.012-2004: Occupational safety stаndards system. Vibration safety. General requirements
GOST 13837-79: General purpose dynamometers
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 177-88: Hydrogen peroxide
GOST 19715-74: Red Cross emblem. Form, dimensions and application rules
GOST 22576-90: Motor vehicles. Speed characteristics. Test methods
GOST 23337-2014: Noise. Methods of noise measurement in residential areas and in the rooms of residential, public and community buildings
GOST 25644-96: Powder synthetic detergents. General technical requirements
GOST 28385-89: Movable medical-purpose complexes on chassis. Colographic schemes. Identification signs. Technical requirements
GOST 31508-2012: Medical products. Classification in accordance with potential risk of using. General requirements
GOST 7502-98: Measuring metal tapes. Specifications
GOST 9.032-74: Unified, system of corrosion and ageing protection. Paint coatings. Groups, technical requirements and designations
GOST 9.301-86: Unified system of corrosion and ageing protection. Metal and non-metal inorganic coatings. General requirements
GOST 9.302-88: Unified system of corrosion and ageing protection. Metal and non-metal inorganic coatings. Control methods
GOST 9.401-91: Unified system of corrosion and ageing protection. Paint coatings. General requirements and methods of accelerated tests on resistance to the action of climatic factors.
GOST ISO 10993-10-2011: Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST ISO 10993-11-2011: Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST ISO 10993-1-2011: Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-12-2011: Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST ISO 10993-13-2011: Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-14-2011: Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST ISO 10993-15-2011: Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST ISO 10993-16-2011: Medical devices. Biological evaluation of medical devices. Part 16. Toxic kinetic study design for degradation products and leachable
GOST ISO 10993-17-2011: Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances
GOST ISO 10993-18-2011: Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST ISO 10993-3-2011: Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GOST ISO 10993-4-2011: Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-5-2011: Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-6-2011: Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 10993-7-2011: Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-9-2011: Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST R 50444-92: Medical instruments, apparatus and equipment. General specifications
GOST R 50574-2002: Automobiles, buses and motorcycles of emergency services. Colours diagrams, identification symbols, inscriptions, special light and sound signals. General requirements
GOST R 52567-2006: Road ambulances. Technical requirements and test methods
GOST R 53228-2008: Non-automatic weighing instruments. Part 1. Metrological and technical requirements. Tests
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 60601-1-2-2014: Medical electrical equipment. Part 1-2. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
GOST R IEC 60601-1-3-2013: Medical electrical equipment. Part 1-3. General requirements for basic safety and essential performance. Collateral Standard. Radiation protection in diagnostic X-ray equipment
SanPiN 2.1.3.2630-10: Sanitary and epidemiological requirements for organizations engaged in medical activities
SanPiN 2.1.7.2790-10: Sanitary and epidemiological requirements for the management of medical waste
SanPiN 2.6.1.2523-09: Norms of radiation safety
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