BS EN 60601-2-16:2015
$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 | 2015 | 74 |
IEC 60601-2-16:2012 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2012 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 60601-2-16:2012 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 60601-2-16:2012 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fourth edition cancels and replaces the third edition of IEC 60601-2-16, published in 2008. This edition constitutes a technical revision. Changes since the previous edition include, among others, better adaptation of IEC 60601-1-8 and improvement of subclause 201.8.3.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 8 | 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 |
| 18 | 201.4 General requirements Tables Table 201.101 – essential performance requirements |
| 21 | 201.5 General requirements for testing of me equipment |
| 22 | 201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents |
| 25 | 201.8 Protection against electrical hazards from me equipment |
| 26 | 201.9 Protection against mechanical hazards of me equipment and me systems |
| 27 | 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards |
| 28 | 201.12 * Accuracy of controls and instruments and protection against hazardous outputs |
| 34 | Figure 201.101 – Continuous air infusion test set-up with example dimensions |
| 36 | 201.13 hazardous situations and fault conditions |
| 37 | 201.14 programmable electrical medical systems (pems) 201.15 Construction of me equipment |
| 38 | 201.16 * Me systems |
| 39 | 201.17 Electromagnetic compatibility of me equipment and me systems 202 Electromagnetic compatibility – Requirements and tests 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| 41 | 210 Process 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 Annexes |
| 42 | Annex G (normative) Protection against hazards of ignition of flammable anaesthetic mixtures |
| 43 | Annex AA (informative) Particular guidance and rationale |
| 57 | Figure AA.1 – Example of the haemodialysis me system |
| 59 | Table AA.1 – Possible alarm condition priorities according to 6.1.2 of IEC 60601-1-8:2006, |
| 61 | 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 |
| 69 | Bibliography |
| 70 | Index of defined terms used in this particular standard |
