Table of Contents

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
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 parts and ACCESSORIES
201.103 Oxygen pressure regulators
202 Medical electrical equipment - Part 1-2: General
    requirements for basic safety and essential
    performance - Collateral standard: Electromagnetic
    compatibility - Requirements and tests
208 Medical electrical equipment - Part 1-8: General
    requirements for basic safety and essential
    performance - Collateral Standard: General
    requirements, tests and guidance for alarm
    systems in medical electrical equipment
    and medical electrical systems
211 Medical electrical equipment - Part 1-11: General
    requirements for basic safety and essential
    performance - Collateral Standard: Requirements
    for medical electrical equipment and medical electrical
    systems used in the home healthcare environment
Annex A (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME
        SYSTEMS
Annex B (informative) - Symbols on marking
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) - Reference to the Essential Principles
Bibliography

Abstract

Pertains to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as me equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 121
Supersedes	ISO/DIS 80601-2-67 : 60.00 (2014)