ГОСТ Р ИСО 80601-2-13—2013
Библиография
[1] ISO 3746, Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound
pressure — Survey method using an enveloping measurement surface over a reflecting plane
[2] ISO 5358:1980, Continuous flow inhalational anaesthetic apparatus (anaesthetic machines) for use with humans
[3] ISO 5358:1992. Anaesthetic machines for use with humans
[4] ISO 8185. Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification
systems
[5] ISO 8835-71*, Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited
logistical supplies of electricity and anaesthetic gases
[6] ISO 10651-4:2002, Lung ventilators — Part 4. Particular requirements for operator-powered resuscitators
[7] ISO 13485. Medical devices— Ouality management systems— Requirements for regulatory purposes
[8] ISO 14155. Clinical investigation of medical devices for human subjects — Gooey clinical practice
[9] ISO.TR 14969. Medical devices — Quality management systems— Guidance on the application of ISO 13485:2003
[10] ISO 14971, Medical devices — Application of risk management to medical devices
[11] ISO.TR 16142. Medical devices — Guidance on the selection of standards in support of recognized essential
principles of safety and performance of medical devices
[12] ISO 80369 (alt parts) 2>, Sm al bore connectors for liquids and gases in healthcare applications
[13] IECTR 60083. Plugs and socket-outlets for domestic and similar general use standardized in member countries
of I EC
[14] IEC 60601-1-3. Medical electrical equipment — Part 1-3: General requirements for basic safety and essential
performance — Collateral Standard: Radiation protection in diagnostic X-ray equipment
[15] IEC 60601-1-4, Medical electrical equipment — Part 1-4: General requirements for safety — Collateral Standard:
Programmable electrical medical systems
[16] IEC 60601-1-11. Medical electrical equipment — Part 1-11: General requirements for basic safety and essential
performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment
[17] IEC 61010 (all parts). Safety requirements for electrical equipment for measurement, control, and laboratory use
[18] EN 15986. Symbols for use in the labelling of medical devices — Requirements for labelling of medical devices
containing phthalates
[19] ASTM F2761-09. Medical devices and medical systems — Essential safety requirements for equipment comprising
the patient-centric integrated clinical environment (ICE) — Part 1: General requirements and conceptual model
[20] BS 4272-3. Anaesthetic and analgesic machines — Specification for continuous flow anaesthetic machines
[21] Lagevin. P.B.. et at. Synchronization of radiograph film exposure with the inspiratory pause effect on the appearance of
bedside chest radiographs in mechanically ventilated patients. American J. of Resp. and Crit. Care Med.. 160(6). 1999,
pp. 2067—2071
[22] Munsell Book of Color, available from http:/i\vww.munse!lstore.com.
11 В стадии публикации.
21 ИСО 80369-1 «Соединители малого калибра для жидкостей и газов при медицинских применениях.
Часть 1.Общие требования» был опубликован в 2010 г. Дальнейшие части серии находятся в стадии разработки.
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