Standard ISO standard · ISO 80601-2-70:2015

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

Status: Withdrawn

· Replaced by: ISO 80601-2-70:2020
Buy this standard

Standard ISO standard · ISO 80601-2-70:2015

Medical Electrical Equipment -- Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
Subscribe on standards - Read more Dölj
Price: 1 770 SEK
standard ikon pdf

PDF

Price: 1 770 SEK
standard ikon

Paper

Show more Show less
Scope
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.

Subjects

Anaesthetic, respiratory and reanimation equipment (11.040.10)


Buy this standard

Standard ISO standard · ISO 80601-2-70:2015

Medical Electrical Equipment -- Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
Subscribe on standards - Read more Dölj
Price: 1 770 SEK
standard ikon pdf

PDF

Price: 1 770 SEK
standard ikon

Paper

Show more Show less

Product information

Language: English

Written by: ISO

International title:

Article no: STD-918462

Edition: 1

Approved: 1/12/2015

No of pages: 46

Replaces: ISO 17510-1:2007

Replaced by: ISO 80601-2-70:2020