Table of Contents

FOREWORD
European 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 of
        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
        for ME EQUIPMENT
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 Gas connections
201.102 Requirements for the VBS and ACCESSORIES
201.103 Spontaneous breathing during loss of power
        supply
201.104 Training
201.105 Indication of duration of operation
201.106 FUNCTIONAL CONNECTION
201.107 Display loops
201.108 POWER SUPPLY CORDS
201.109 VENTILATORY SUPPORT EQUIPMENT security
202 Electromagnetic disturbances - Requirements and
    tests
206 Usability
208 General requirements, tests and guidance for alarm
    systems in medical electrical equipment and medical
    electrical systems
211 Requirements for medical electrical equipment and
    medical electrical systems used in the home healthcare
    environment
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Data interface requirements
Annex CC (informative) - Reference to the ESSENTIAL PRINCIPLES
Annex DD (informative) - Terminology - Alphabetized index of
         defined terms
Annex ZA (informative) - Relationship between this Document
         and the Essential Requirements of EU Directive 93/42/EEC
Bibliography

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, for VENTILATORY INSUFFICIENCY, as defined in 201.3.203, hereafter also referred to as ME EQUIPMENT, in combination with its ACCESSORIES: - intended for use in the HOME HEALTHCARE ENVIRONMENT; - intended for use by a LAY OPERATOR; and - intended for use with PATIENTS who have VENTILATORY INSUFFICIENCY or failure, but who are not dependent on mechanical ventilation for their life support.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 121