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
       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 PULSE OXIMETER PROBES and PROBE
        CABLE EXTENDERS
201.102 Saturation pulse INFORMATION SIGNAL
201.103 FUNCTIONAL CONNECTION
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
212 Requirements for medical electrical equipment and
    medical electrical systems used in the emergency
    medical services environment
Annex C (informative) - Guide to marking and labeling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and
         rationale
Annex BB (informative) - Skin temperature at the
         PULSE OXIMETER PROBE
Annex CC (informative) - Determination of
         ACCURACY
Annex DD (informative) - Calibration standards
Annex EE (informative) - Guideline for evaluating
         and documenting SpO[2] ACCURACY in human subjects
Annex FF (informative) - Simulators, calibrators and FUNCTIONAL
         TESTERS for PULSE OXIMETER EQUIPMENT
Annex GG (informative) - Concepts of ME EQUIPMENT
          response time
Annex HH (normative) - Data interface requirements
Annex II (informative) - Reference to the ESSENTIAL
         PRINCIPLES
Annex JJ (informative) - Terminology - alphabetized
         index of defined terms
Bibliography

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 121
Supersedes	ISO 80601-2-61 : 2011