Logo
Login Sign Up
Current Revision

BSI PD ISO/TR 21954:2018

Guidance on the selection of the appropriate means of ventilation based on the intended patient, use environment, and operator
Best Price Guarantee
Instant

$409.89

2-5 Days

$409.89

SAVE 10%

$737.80


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


View in Library
or
British Standards Institution Logo

BSI PD ISO/TR 21954:2018

Guidance on the selection of the appropriate means of ventilation based on the intended patient, use environment, and operator

PUBLISH DATE 2018
PAGES 48
BSI PD ISO/TR 21954:2018

This document considers and identifies criteria about the intended patient, intended use environment, and intended operator across the spectrum of the types of ventilation-related equipment as listed below:

  • gas-powered resuscitator as specified in ISOĀ 10651-5[1];

  • operator-powered resuscitator as specified in ISOĀ 10651-4[2];

  • ventilator for critical care as specified in ISOĀ 80601-2-12[3]Ā 2;

  • ventilator for emergency medical services environment as specified in ISOĀ 80601-2-84[4]Ā 3, the future replacement for ISOĀ 10651-3[5];

    NOTEĀ 1 ISOĀ 80601‐2‐84 updates the content of ISOĀ 10651‐3 and harmonizes it with IECĀ 60601-1:2005+AMD1:2012[6] and IECĀ 60601-1-12:2014[7].

  • ventilator for ventilatory impairment in the home healthcare environment as specified in ISOĀ 80601-2-79[8];

  • ventilator for ventilatory insufficiency in the home healthcare environment as specified in ISOĀ 80601-2-80[9];

  • ventilator for ventilator-dependent patients in the home healthcare environment as specified in ISOĀ 80601-2-72[10];

  • sleep apnoea breathing therapy equipment as specified in ISO 80601-2-70[11].

    NOTEĀ 2 Sleep apnoea breathing therapy equipment is not considered to be an artificial ventilator. It is included in this discussion to highlight the differences, which indicate why sleep apnoea breathing therapy equipment is not considered a ventilator.

This document is intended to provide guidance that can assist manufacturers, authorities having jurisdiction and users in the development, selection and application of different types of ventilatory equipment based on the intended patient, intended use environment and intended operator.

1 Numbers in square brackets refer to the Bibliography.

2 Under preparation. Stage at the time of publication: ISO/FDIS 80601-2-12:2018.

3 Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2018.

SDO BSI: British Standards Institution
Document Number ISO/TR 21954
Publication Date July 24, 2018
Language en - English
Page Count
Revision Level
Supercedes
Committee CH/121/9
Loading...

Failed to load document history.

Publish Date Document Id Type View