BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

FOREWORD
INTRODUCTION
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 General requirements, tests and guidance
    for EMS 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 (normative) - Data interface requirements
Annex II (informative) - Reference to the
         Essential Principles
Annex JJ (informative) - Terminology -
         alphabetized index of defined terms
Bibliography
Annex ZA (informative) - Relationship between
         this Document and the Essential
         Requirements of EU Directive 93/42/EEC

BS EN ISO 80601-2-61.

Committee	CH/121/9
DocumentType	Draft
Pages	115
PublisherName	British Standards Institution
Status	NA

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