NS-EN ISO 80601-2-12:2023
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023)
Hardcopy
English
01-11-2023
Important note : Users cannot be edited or removed once added to your Multi user PDF.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 |
| Standards | Relationship |
| EN ISO 80601-2-12:2023 | Identical |
| ISO 80601-2-12:2023 | Identical |
| ISO 3744:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane |
| 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 |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to medical devices |
| ISO 32:1977 | Gas cylinders for medical use — Marking for identification of content |
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