BS EN IEC 60601-2-16:2019
$215.11
Medical electrical equipment – Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 82 |
IEC 60601-2-16:2018 is also available as /2 which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-2-16:2018 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2018 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2018 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2018 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16, published in 2012. This edition includes the following significant technical changes with respect to the previous edition: a) update of 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, of references to IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to IEC 60601-1-11:2015; b) widening of the scope; c) editorial improvements; d) addition of requirements for anticoagulant delivery means; e) other few small technical changes.
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 |
| 9 | FOREWORD |
| 12 | INTRODUCTION |
| 13 | 201.1 Scope, object and related standards |
| 15 | 201.2 Normative references |
| 16 | 201.3 Terms and definitions |
| 19 | 201.4 General requirements Table 201.101 – essential performance requirements |
| 22 | 201.5 General requirements for testing me equipment 201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents |
| 27 | 201.8 Protection against electrical hazards from me equipment |
| 28 | 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 |
| 29 | 201.12 * Accuracy of controls and instruments and protection against hazardous outputs |
| 35 | Figure 201.101 – Continuous air infusion test setup with example dimensions |
| 39 | 201.13 Hazardous situations and fault conditions for me equipment 201.14 Programmable electrical medical systems (pems) |
| 40 | 201.15 Construction of me equipment 201.16 * Me systems |
| 41 | 201.17 Electromagnetic compatibility of me equipment and me systems 202 Electromagnetic disturbances – Requirements and tests |
| 42 | 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| 44 | 209 Requirements for environmentally conscious design 210 Requirements for the development of physiologic closed-loop controllers 211 * Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| 46 | Annexes |
| 47 | Annex G (normative) Protection against hazards of ignition of flammable anaesthetic mixtures |
| 48 | Annex AA (informative) Particular guidance and rationale |
| 63 | Figure AA.1 – Example of a haemodialysis me system |
| 65 | Table AA.1 – Example of alarm condition priorities accordingto 6.1.2 of IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, adapted for haemodialysis equipment needs |
| 67 | Annex BB (informative) Examples of hazards, foreseeable sequences of events, and hazardous situations in haemodialysis equipment Table BB.1 – Hazardous situation list following ISO 14971:2007, Annex E |
| 76 | Bibliography |
| 79 | Index of defined terms used in this particular standard |
