Table of Contents

Foreword<br>Introduction<br>201.1 Scope, object, and related standards<br>201.2 Normative references<br>201.3 Terms and definitions<br>201.4 General requirements<br>201.5 General requirements for testing of ME EQUIPMENT<br>201.6 Classification of ME EQUIPMENT and ME SYSTEMS<br>201.7 ME EQUIPMENT identification, marking, and documents<br>201.8 Protection against electrical HAZARDS from ME EQUIPMENT<br>201.9 Protection against MECHANICAL HAZARDS of ME<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EQUIPMENT and ME SYSTEMS<br>201.10 Protection against unwanted and excessive radiation<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;HAZARDS<br>201.11 Protection against excessive temperatures and other<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;HAZARDS<br>201.12 Accuracy of controls and instruments and protection<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;against hazardous outputs<br>201.13 HAZARDOUS SITUATIONS and fault conditions<br>201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)<br>201.15 Construction of ME EQUIPMENT<br>201.16 ME SYSTEMS<br>201.17 Electromagnetic compatibility of ME EQUIPMENT<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and ME SYSTEMS<br>201.101 Interfering gas and vapour effects<br>201.102 Gas leakage<br>201.103 Port connectors for DIVERTING RGMs<br>201.104 Sampling flowrate<br>201.105 Contamination of breathing systems<br>201.106 FUNCTIONAL CONNECTION<br>202 Electromagnetic disturbances - Requirements and tests<br>206 USABILITY<br>208 General requirements, tests and guidance for ALARM<br>&nbsp;&nbsp;&nbsp;&nbsp;SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT and<br>&nbsp;&nbsp;&nbsp;&nbsp;MEDICAL ELECTRICAL SYSTEMS<br>211 General requirements, tests and guidance for medical<br>&nbsp;&nbsp;&nbsp;&nbsp;electrical equipment and medical electrical systems used<br>&nbsp;&nbsp;&nbsp;&nbsp;in the home healthcare environment<br>212 General requirements, tests and guidance for MEDICAL<br>&nbsp;&nbsp;&nbsp;&nbsp;ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL<br>&nbsp;&nbsp;&nbsp;&nbsp;SYSTEMS intended for use in the EMERGENCY<br>&nbsp;&nbsp;&nbsp;&nbsp;MEDICAL SERVICES ENVIRONMENT<br>Annex C (informative) - Guide to marking and labeling<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;requirements for ME EQUIPMENT and ME SYSTEMS<br>Annex D (informative) - Symbols on marking<br>Annex AA (informative) - Particular guidance and rationale<br>Annex BB (informative) - Test gas mixtures for calibration<br>Annex CC (informative) - Data interface requirements<br>Annex DD (informative) - Alphabetized index of defined<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;terms used in this document<br>Bibliography

Abstract

This document specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a<br>RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS<br>OPERATION for use with a PATIENT.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 121
Supersedes	ISO 80601-2-55 : 2011