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 1Mr Fernando IsazaPPUB2020-062021

History

Stage
Document
Downloads
Decision Date
Target Date
AMW
62D/1372/RR PDF file 104 kB
2016-07-29 
1CD
62D/1373/CD PDF file 1659 kB
2016-07-302016-07
ACDV
62D/1421/CC Word file 727 kB
PDF file 1300 kB
2016-10-282016-11
ACDV
62D/1421A/CC PDF file 982 kB
Word file 234 kB
2016-10-282016-11
CCDV
62D/1503/CDV
2017-09-292017-11
CCDV
62D/1503A/CDV PDF file 3072 kB
2017-09-292017-11
PRVC
2017-12-222017-12
AFDIS
62D/1579/RVC PDF file 2106 kB
Word file 1299 kB
2018-03-092018-03
AFDIS
62D/1579A/RVC PDF file 1718 kB
Word file 1196 kB
2018-03-092018-03
ACDV
62D/1579B/RVC PDF file 3301 kB
Word file 357 kB
2018-06-222018-07
CCDV
62D/1617/CDV
PDF file 3992 kB
2018-08-102018-06
PRVC
2018-11-022018-11
AFDIS
62D/1655/RVC PDF file 1424 kB
Word file 950 kB
2018-11-092019-08
AFDIS
62D/1655A/RVC PDF file 1628 kB
Word file 1039 kB
2018-11-092019-08
CFDIS
62D/1706/FDIS
2019-08-162019-08
PRVD
2019-09-272019-09
APUB
62D/1725/RVD PDF file 706 kB
2019-10-182019-10
BPUB
2020-04-032019-10
PPUB
2020-04-032020-06
  

Abstract

This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:
  • 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;

NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.

NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator).

NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.

  • intended to be operated by a healthcare professional operator; and
  • intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.

A critical care ventilator is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.

This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.

NOTE 4 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.

NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation.

NOTE 6 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining.

This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.

This document does not specify the requirements for:

  • ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[2];
  • ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84[3], the future replacement for ISO 10651-3[4];
  • ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72:2015[5];
  • ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018[6] and ISO 80601-2-80:2018[7][1];
  • obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[9];
  • continuous positive airway pressure (CPAP) ME equipment;
  • high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87[63];

NOTE 7 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes.

  • oxygen therapy constant flow ME equipment; and
  • cuirass or "iron-lung" ventilation equipment.

[1] ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.


Project

ISO 80601-2-12:2020 ED2

Medical electrical equipment - Part 2-12: Particular requirements for the basic safety and essential performance of critical care ventilators