CSA C22.2 No. 60601.2.39 : 2009 : R2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
13-07-2021
English
01-01-2014
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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Superseded
|
| Standards | Relationship |
| 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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