Table of Contents

Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT
        and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
        HAZARDS
201.11 Protection against excessive temperatures and other
        HAZARDS
201.12 Accuracy of controls and instruments and protection
        against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT AND ME
        SYSTEMS
201.101 Additional requirements for ANAESTHETIC GAS DELIVERY
        SYSTEMS
201.102 Additional requirements for an ANAESTHETIC BREATHING
        SYSTEM
201.103 Additional requirements for an ANAESTHETIC GAS
        SCAVENGING SYSTEM
201.104 Additional requirements for an ANAESTHETIC VAPOUR
        DELIVERY SYSTEM
201.105 Additional requirements for an ANAESTHETIC VENTILATOR
        pause
201.106 Display loops
201.107 Clinical evaluation
202 Electromagnetic compatibility - Requirements and tests
203 General requirements for radiation protection in
        diagnostic X-ray equipment
206 Usability
208 General requirements, tests and guidance for ALARM
        SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
        ELECTRICAL SYSTEMS
209 Requirements for environmentally conscious design
210 PROCESS requirements for the development of physiologic
        closed-loop controllers
211 Requirements for MEDICAL EECTRICAL EQUIPMENT and MEDICAL
        ELECTRICAL SYSTEMS used in the home healthcare
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME SYSTEMS or their
        parts
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (normative) - Test for flammability of anaesthetic
         agent
Annex CC (informative) - Environmental aspects
Annex DD (informative) - Reference to the essential principles
Bibliography
Alphabetized index of defined terms used in this particular
standard

Abstract

This International Standard is applicable to the basic safety and Essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 121
Supersedes	ISO/DIS 80601-2-13 : 60.00 (2011)