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CSA C22.2 No. 60601.2.39 : 2009 : R2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PERITONEAL DIALYSIS EQUIPMENT
Available format(s)

Hardcopy , PDF

Superseded date

07-13-2021

Language(s)

English

Published date

01-01-2014

FOREWORD
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 PD EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 PD EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from PD 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
203 General requirements for radiation protection in diagnostic
    X-ray equipment
206 Usability
208 General requirements, tests and guidance for alarm systems.
    in medical electrical equipment and medical electrical systems
209 Requirements for the reduction of environmental impacts
210 Process requirements for the development of physiologic
    closed-loop controllers
Annexes
Annex G (normative) - Protection against HAZARDS of ignition
        of flammable anaesthetic mixtures
Annex AA (informative) - Particular guidance and rationale
Index of defined terms used in this particular standard

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT, hereafter referred to as PD EQUIPMENT.

DocumentType
Standard
Pages
58
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy

Standards Relationship
IEC 60601-2-39:2007 Identical
IEC 60601-2-39:2007 Identical

IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

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