BS EN IEC 60601-2-39:2019
$167.15
Medical electrical equipment – Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 34 |
IEC 60601-2-39:2018 is also available as IEC 60601-2-39:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-2-39:2018 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 third edition cancels and replaces the second edition of IEC 60601-2-39. It constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition: – update of the references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 and of references and requirements to IEC 60601-1-11:2015; – editorial improvements; – improvement of the essential performance requirements clause/subclauses; – new requirements for the interruption of the power supply.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 5 | Annex ZA(normative)Normative references to international publicationswith their corresponding European publications |
| 7 | English CONTENTS |
| 8 | FOREWORD |
| 11 | INTRODUCTION |
| 12 | 201.1 Scope, object and related standards |
| 14 | 201.2 Normative references 201.3 Terms and definitions |
| 15 | 201.4 General requirements |
| 16 | Table 201.101 – essential performance requirements |
| 18 | 201.5 General requirements for testing me equipment |
| 19 | 201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents |
| 20 | 201.8 Protection against electrical hazards from me equipment |
| 21 | 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 |
| 22 | 201.12 Accuracy of controls and instruments and protection against hazardous outputs |
| 24 | 201.13 Hazardous situations and fault conditions for me equipment 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment 201.16 Me systems |
| 25 | 201.17 Electromagnetic compatibility of me equipment and me systems 202 Electromagnetic disturbances – Requirements and tests 202.8 Electromagnetic immunity requirements for me equipment and me systems 208 * General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| 26 | 209 Requirements for environmentally conscious design |
| 27 | 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| 28 | Annexes |
| 29 | Annex G (normative) Protection against hazards of ignition of flammable anaesthetic mixtures |
| 30 | Annex AA (informative) Particular guidance and rationale |
| 31 | Bibliography |
| 32 | Index of defined terms used in this particular standard |
