EN ISO 80601-2-61:2011

Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative reference
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 PULSE OXIMETER PROBES and PROBE
        CABLE EXTENDERS
201.102 Saturation pulse INFORMATION SIGNAL
201.103 SIGNAL INPUT/OUTPUT PART
202 Medical electrical equipment - Part 1-2: General
        requirements for safety - Collateral standard:
        Electromagnetic compatibility - Requirements
        and tests
208 Medical electrical equipment - Part 1-8:
        General requirements for safety - Collateral
        Standard: General requirements, tests and
        guidance for alarm systems in medical electrical
        equipment and medical electrical systems
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) - 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 S[p]O[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 (informative) - Reference to the essential principles
         of safety and performance of medical devices
         in accordance with ISO/TR 16142
Bibliography
Alphabetized index of defined terms used in this standard
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
          Requirements of EU Directive 93/42/EEC

ISO 80601-2-61:2011 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed.The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment.ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.ISO 80601-2-61:2011 can also be applied to pulse oximeter equipment and their accessories used for compensation or alleviation of disease, injury or disability.ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended solely for foetal use.ISO 80601-2-61:2011 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.