ГОСТ Р ИСО 80601-2-12-2013
Библиография
[1] ISO 5356-2:2006. Anaesthetic and respiratory equipment - Conical connectors - Part
2: Screwthreaded weight-bearing connectors
[2] ISO 10651-2, Lung ventilators for 30 medical use - Particular requirements for basic
safety and essential performance - Part 2: Home care ventilators for ventilator-
dependent patients
[3] ISO 10651-3, Lung ventilators for medical use - Part 3: Particular requirements for
emergency and transport ventilators
[4] ISO 10651-4, Lung ventilators - Part 4: Particular requirements for operator-powered
resuscitators
[5] ISO 10651-6, Lung ventilators for medical use - Particular requirements for basic
safety and essential performance - Part 6: Home-care ventilatory support devices
[6]ISO 14159, Safety of machinery - Hygiene requirements for the design of machinery
[7]ISO 14971, Medical devices - Application of risk management to medical devices
[8] ISO/TR 16142:2006, Medical devices - Guidance on the selection of standards in
support of recognized essential principles of safety and performance of medical
devices
[9] ISO 17664,Sterilization of medical devices - Information to be provided by the
manufacturer for the processing of resterilizable medical devices
[10J IEC 60601-1-3:2008, Medical electrical equipment - Part 1-3: General requirements for
basic safety and essential performance - Collateral Standard - Radiation
protection in diagnostic X-ray equipment
(11] IEC 60601-2-12:2001, Medical electrical equipment - Part 2: Particular requirements
for the safety of lung ventilators. Critical care ventilators
(12] IEC 60721-3-7, Classification of environmental conditions - Part 3-7: Classification of
groups of environmental parameters and their severities - Portable and non-stationary
use
(13] IEC/TR 60721-4-7, Classification of environmental conditions - Part 4-7: Guidance for
the correlation and transformation of environmental condition classes of IEC 60721-3 to
the environmental tests of IEC 60068 - Portable and non-stationary use
(14]IEC/TR 60878:2003, Graphical symbols for electrical equipment in medical practice
(15] IEC 62366:2007, Medical devices - Application of usability engineering to medical
devices
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