International Standards and Conformity Assessment for all electrical, electronic and related technologies

SC 62D

Electromedical equipment

 

Detail

Committee
Working Groups
Project Leader

Current

Status

Frcst Pub

Date

Stability

Date

SC 62DJWG 12 H. LasthausPPUB2014-102020

History

Stage
Document
Downloads
Decision Date
Target Date
PNW
62D/941/NP PDF file 656 kB
2011-07-08 
ANW
62D/962A/RVN PDF file 716 kB
2011-10-142011-11
1CD
62D/969/CD PDF file 755 kB
2011-12-162012-10
CDM
62D/1005/CC Word file 171 kB
PDF file 951 kB
2012-04-062012-04
ACDV
62D/1005A/CC Word file 207 kB
PDF file 458 kB
2013-01-252012-07
CCDV
62D/1070/CDV PDF file 408 kB
2013-04-052013-04
AFDIS
62D/1095/RVC Word file 776 kB
PDF file 1494 kB
2013-09-062013-10
AFDIS
62D/1095A/RVC Word file 812 kB
PDF file 1607 kB
2013-09-062013-10
CFDIS
62D/1153/FDIS
2014-06-27 
APUB
62D/1164/RVD PDF file 248 kB
2014-09-08 
BPUB
2014-09-09 
PPUB
2015-01-122014-11
 2019-02

Abstract

ISO 80601-2-70:2015 is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as me equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. It excludes sleep apnoea breathing therapy equipment intended for use with neonates. ISO 80601-2-70:2015 is applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation. ISO 80601-2-70:2015 is not applicable to me equipment or an me system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea. ISO 80601-2-70:2015 is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.

Project

ISO 80601-2-70:2015 ED1

Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

 

 

Associated Documents:

62D/1674/RR

PDF file 107 kB