IEC 80601-2-30 : 2.0

MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS

International Electrotechnical Committee

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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 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 Requirements for CUFFS
201.102 Connection tubing and CUFF connectors
201.103 Unauthorized access
201.104 Maximum inflating time
201.105 Automatic cycling modes
201.106 Clinical accuracy
202 Electromagnetic disturbances - Requirements and
        tests
206 Usability
210 Requirements for the development of physiologic
        closed-loop controllers
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 intended for
        use in the emergency medical services environment
Annexes
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and
        ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Environmental aspects
Annex CC (informative) - Reference to the ESSENTIAL PRINCIPLES
Bibliography
Index of defined terms

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT, which by means of an inflatable CUFF, are used for non-continuous indirect estimation of the BLOOD PRESSURE without arterial puncture.