Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023)

Available format(s)

Hardcopy

Language(s)

English

Published date

01-11-2023

Publisher

Norwegian Standards (Norges Standardiseringsforbund)

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as MEequipment: ¾ intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE2 For the purposes of this document, such an environment is referred to as a critical care environment.

Committee	ISO/TC 121
DocumentType	Standard
Pages	162
ProductNote	This standard also refers to ISO 80369-2, ISO 80601-2-13, IEC 80001-2-5:2014
PublisherName	Norwegian Standards (Norges Standardiseringsforbund)
Status	Current
Supersedes	NS-EN ISO 80601-2-12:2020

Standards	Relationship
EN ISO 80601-2-12:2023	Identical
ISO 80601-2-12:2023	Identical

ANSI/AAMI 2700-1:2019

Medical Devices and Medical Systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model