CSA C22.2 No. 80601-2-30 : 2010 : R2015

Superseded

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

Available format(s)

Hardcopy , PDF

Superseded date

16-10-2019

Language(s)

English

Published date

01-01-2015

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 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 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 compatibility - Requirements and tests
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

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 intermittent indirect measurement of the BLOOD PRESSURE without arterial puncture.

DevelopmentNote	Amendment 1 is available separately, see CSA C22.2.80601-2-30A. (10/2015)
DocumentType	Standard
Pages	140
ProductNote	Reconfirmed EN
PublisherName	Canadian Standards Association
Status	Superseded
SupersededBy	CSA C22.2 No. 80601-2-30A : 2015 CSA C22.2 NO. 80601-2-30:19
Supersedes	CSA C22.2 No. 80601-2-30 : 2010 : INC : COR 1 : 2011

IEC 60068-2-27:2008	Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
ISO 81060-1:2007	Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
IEC 60068-2-31:2008	Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
IEC 60068-2-64:2008	Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
ISO 21647:2004	Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-2:2017	Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
CR 13825:2000	Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
ISO/TR 16142:2006	Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 81060-2:2013	Non-invasive sphygmomanometers Part 2: Clinical investigation of automated measurement type
ISO 9919:2005	Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
ISO 594-2:1998	Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 594-1:1986	Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements