2. Getting involved
3. Standards Committees
4. NARK

Abstract

This document specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (RGM) intended for continuous use with a patient. This amendment updates the references to the IEC 60601-1 series of standards specified throughout this document. This amendment also: a) reinstates Oxygen 21,0 % as a balance gas level in Table 210.103 which, it appears, was deleted in error; b) amends the text regarding drift and accuracy of measurement; c) allows a risk management approach to the prevention of cross infection for RGMs that return sampled gas to the breathing system; d) adds rationale for the typical level or argon that can be found in gas supplied by concentrators.

Begin

2021-07-27

WI

00215333

Planned document number

DIN EN ISO 80601-2-55

Project number

05300489

Responsible national committee

NA 176-05-03 AA - Anaesthesia and artificial respiration  

Responsible european committee

CEN/TC 215/WG 1 - Anaesthetic machines, medical breathing systems and anaesthetic gas scavenging systems  

Responsible international committee

ISO/TC 121/SC 1/JWG 6 - Joint ISO/TC 121/SC 1- IEC/SC 62D WG : Respiratory gas monitors  

draft standard

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/DAM 1:2023); German and English version EN ISO 80601-2-55:2018/prA1:2023
2023-03
Order from DIN Media

previous edition(s)

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018); German version EN ISO 80601-2-55:2018
2019-03