NS-EN ISO 80601-2-84:2023
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO 80601-2-84:2023)
Hardcopy
English
01-11-2023
This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as MEequipment: ¾ intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; ¾ intended to be operated by a healthcare professional operator; ¾ intended for use in the EMS environment; and ¾ intended for invasive or non-invasive ventilation.
| Committee |
ISO/TC 121
|
| DocumentType |
Standard
|
| Pages |
146
|
| PublisherName |
Norwegian Standards (Norges Standardiseringsforbund)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-84:2023 | Identical |
| EN ISO 80601-2-84:2023 | Identical |
| ISO 8836:2019 | Suction catheters for use in the respiratory tract |
| EN ISO 80601-2-12:2023 | Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023) |
| ISO 15223-1:2021 | Medical devices Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements |
| ISO 10651-5:2006 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators |
| ISO 15001:2010 | Anaesthetic and respiratory equipment Compatibility with oxygen |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| ISO 14159:2002 | Safety of machinery — Hygiene requirements for the design of machinery |
| ISO 17510:2015 | Medical devices — Sleep apnoea breathing therapy — Masks and application accessories |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
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