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
11-01-2023
Important note : All end users must be registered with an Account prior to user licenses being assigned.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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