BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical electrical equipment Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Hardcopy , PDF
14-08-2019
English
31-03-2009
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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
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 the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT.
| Committee |
CH/150/2
|
| DevelopmentNote |
Supersedes BS EN 50072 & 97/560940 DC. (11/2005) Supersedes BS 5724-2.39(1999). (03/2009) 2008 version remains current. 2008 Edition Re-issued in March 2012 & incorporates AMD 11 2011. (04/2012) Supersedes BS 5724-2.29(1992) (08/2015)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
Applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This second edition cancels and replaces the first edition of IEC 60601-2-39. It constitutes a technical revision. Major changes since the last edition include a summary of additional essential performance requirements.
| Standards | Relationship |
| UNE-EN 60601-2-39:2009 | Identical |
| IEC 60601-2-39:2007 | Identical |
| EN 60601-2-39:2008/A11:2011 | Identical |
| DIN EN 60601-2-39 : 2008 | Identical |
| NF EN 60601-2-39 : 2008 AMD 11 2012 | Identical |
| I.S. EN 60601-2-39:2008 | Identical |
| SN EN 60601-2-39 : 2008 AMD 11 2011 | Identical |
| EN 50393:2006 | Identical |
| EN 60601-2-39:2008 | 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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