I.S. EN 60601-2-39:2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PERITONEAL DIALYSIS EQUIPMENT (IEC 60601-2-39:2007 (EQV))
Hardcopy , PDF
05-24-2022
English
01-01-2008
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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
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Coverage of Essential Requirements of
EC Directives
Pertains to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment.
| DevelopmentNote |
Supersedes I.S. EN 50072. (06/2005) For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
29
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN 60601-2-39:2008/A11:2011 | Identical |
| BS EN 60601-2-39:2008 | Identical |
| DIN EN 60601-2-39 : 2008 | Identical |
| NF EN 60601-2-39 : 2008 AMD 11 2012 | Identical |
| SN EN 60601-2-39 : 2008 AMD 11 2011 | Identical |
| IEC 60601-2-39:2007 | Identical |
| UNE-EN 60601-2-39:2009 | 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 |
| EN 60601-1-10:2008/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS (IEC 60601-1-10:2007) |
| EN 60601-1-9:2008/A1:2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN (IEC 60601-1-9:2007/A1:2013) |
| 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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