GOST R 50267.12-2006
ГОСТ Р 50267.12-2006
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Medical electrical equipment. Part 2-12. Particular requirements for safety of lung ventilators for critical care ventilation
Изделия медицинские электрические. Часть 2-12. Частные требования безопасности к аппаратам искусственной вентиляции легких для интенсивной терапии
Status: Not effective - Superseded. Information on the registration of 70-st dated 05/07/2013 (official website of Rosstandart); IUS 10-2014
This private standard establishes safety requirements for ventilators that are intended for use in intensive care units. This standard does not deal with devices for independent breathing under constantly positive pressure, devices for treating sleep apnea, supporting ventilators, ventilators for ambulance and transportation, high-frequency and oscillating ventilators. Also not considered are devices that can be used in hospitals solely to enhance the ventilation of self-breathing patients. Requirements for ventilators designed for use during anesthesia are listed in GOST R IEC 60601-2-13
Настоящий частный стандарт устанавливает требования безопасности в аппаратам ИВЛ, которые предназначены для применения в отделениях интенсивной терапии. В настоящем стандарте не рассматриваются устройства для самостоятельного дыхания под постоянно положительным давлением, устройства для лечения сонного апноэ, поддерживающие аппараты ИВЛ, аппараты ИВЛ для скорой помощи и транспортирования, высокочастотные и осцилляционные аппараты ИВЛ. Также не рассматриваются устройства, которые могут использоваться в больницах исключительно для усиления вентиляции самостоятельно дышащих пациентов. Требования к аппаратам ИВЛ, предназначенным для применения во время анестезии, приведены в ГОСТ Р МЭК 60601-2-13
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
12/15/2006
SKU: RUSS71795
The Product is Contained in the Following Classifiers:
PromExpert »
SECTION III. LABOR PROTECTION AND SAFETY »
III Occupational safety requirements for production equipment and processes »
2 Safety requirements for certain types of work »
2.10 Operation of electrical installations, electrical equipment and power tools »
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 ISO 80601-2-12-2013: Medical electrical equipment. Part 2-12. Particular requirements for the basic safety and essential performance of critical care ventilators
As a Replacement Of:
GOST R 50267.12-93: Medical electrical equipment. Part 2. Particular requirements for the safety of lung ventilators for medical use
GOST R ISO 10651.1-99: Lung ventilators for medical use. Part 1. Technical requirements
The Document References:
GOST 24264-93: Anaesthetic and respiratory equipment. Conical connectors. Part 1. Cones and sockets
GOST R 50267.0.2-2005: Medical electrical equipment. Part 1-2. General requirements for safety. Electromagnetic compatibility. Requirements and test methods
GOST R 50267.0.4-99: Medical electrical equipment. Part 1. General requirements safety. 4. Collateral standard. Programmable medical electrical systems
GOST R 52566-2006: Oxygen monitors for monitoring patient breathing mixtures. Safety requirements
GOST R ISO 11134-2000: Sterilization of health care products. Requirements for validation and routine control. Industrial moist heat sterilization
GOST R ISO 11135-2000: Medical devices. Validation and routine control of ethylene oxide sterilization
GOST R ISO 11137-2000: Sterilization of health care products. Requirements for validation and routine control. Radiation sterilization
GOST R ISO 11138-1-2000: Sterilization of health care products. Biological indicators. Part 1. General requirements
GOST R ISO 11138-2-2000: Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization
GOST R ISO 11138-3-2000: Sterilization of health care products. Biological indicators. Part 3. Biological indicators for moist heat sterilization
GOST R ISO 15223-2002: Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied
GOST R ISO 8185-99: Humidifiers for medical use. Technical requirements and test methods
GOST R ISO 9703.1-99: Anaesthesia and respiratory care alarm signals. Part 1. Visual alarm signals
GOST R ISO 9703.2-99: Anaesthesia and respiratory care alarm signals. Part 2. Auditory alarm signals
GOST R ISO 9703.3-99: Anaesthesia and respiratory care alarm signals. Part 3. Guidance on application of alarms
GOST R ISO 9918-99: Capnometers for use with humans. Requirements
GOST R ISO 9919-99: Pulse oximeters for medical use. Technical requirements and test methods
The Document is Referenced By:
GOST 31057-2012: Resuscitators intended for use with humans. General technical requirements and test methods
GOST 31511.2-2012: Lung ventilators for medical use. Part 2. Particular requirements for home care ventilators
GOST R 52792-2007: Low-pressure hose assemblies for use with medical gases. Technical requirements and test methods
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