Medical electrical equipment Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Amended by

BS EN 60601-2-39:2008+A11:2011

Available format(s)

Hardcopy , PDF

Superseded date

14-08-2019

Superseded by

BS EN IEC 60601-2-39:2019

Language(s)

English

Published date

31-03-2009

Publisher

British Standards Institution

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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	BS EN IEC 60601-2-39:2019
Supersedes	BS 5724-2.29(1992) : 1992 BS EN 60601-2-39:1999 BS EN 50072:1992 BS 5724-2.39(1999) : 1999 97/560940 DC : MAR 97

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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BS EN 60601-2-39:2008

Medical electrical equipment Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Table of Contents

Abstract

General Product Information

Scope

International Equivalents

Standards Referencing This Book

Category

Subcategory