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 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 form 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 Training
201.104 Indication of duration of operation
201.105 FUNCTIONAL CONNECTION
201.106 Display loops
202 Electromagnetic disturbances Requirements and tests
206 Usability
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 36
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

Defines requirements for VENTILATORY SUPPORT EQUIPMENT that is intended for use in the HOME HEALTHCARE ENVIRONMENT for PATIENTS who are not dependent for ventilation for their life support.

General Product Information

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