CSA C22.2 No. 60601.2.34 : 2012

Superseded

MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT

Available format(s)

Hardcopy , PDF

Superseded date

01-20-2020

Language(s)

English

Published date

01-01-2012

Publisher

Canadian Standards Association

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
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
202 Electromagnetic compatibility - Requirements and tests
208 General requirements, tests and guidance for alarm
    systems in medical electrical equipment and medical
    electrical systems
Annexes
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Alarm diagrams 208/IEC 60601-1-8:2006
Bibliography
Index of defined terms used in this particular standard

Pertains to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT, hereinafter referred to as ME EQUIPMENT.

DevelopmentNote	To be read in conjunction with CSA C22.2.60601.1. (07/2013)
DocumentType	Standard
Pages	160
PublisherName	Canadian Standards Association
Status	Superseded
SupersededBy	CAN/CSA-C22.2 NO. 60601-2-34:12 (R2017)
Supersedes	CSA C22.2 No. 60601.2.34 : 2002

IEC 80601-2-30:2009+AMD1:2013 CSV	Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
CSA C22.2 No. 60601.1.2 : 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS