1、 IEC/TR 62653 Edition 1.0 2012-06 TECHNICAL REPORT Guideline for safe operation of medical equipment used for haemodialysis treatments IEC/TR 62653:2012(E) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this
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9、alysis treatments INTERNATIONAL ELECTROTECHNICAL COMMISSION U ICS 11.040.20; 11.040.25 PRICE CODE ISBN 978-2-83220-133-6 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. 2 TR 62653 IEC:2012(E)
10、CONTENTS FOREWORD . 3 INTRODUCTION . 5 1 Scope . 6 2 Normative references . 6 3 Terms and definitions . 6 4 Requirements . 12 4.1 Personnel, qualification . 12 4.2 Training . 12 4.3 Infrastructure . 12 4.3.1 General . 12 4.3.2 Infrastructure requirements 13 5 Treatment . 15 5.1 General . 15 5.2 Prep
11、aration . 15 5.2.1 DIALYSIS MACHINE . 15 5.2.2 * DIALYSIS FLUID PREPARATION . 15 5.2.3 * EXTRACORPOREAL CIRCUIT 16 5.2.4 DIALYSIS FLUID compartment 16 5.2.5 PATIENT . 16 5.3 Treatment 17 5.3.1 Preparing the vascular access . 17 5.3.2 * Connection to the EXTRACORPOREAL CIRCUIT 17 5.3.3 Initiation of
12、treatment . 17 5.3.4 Checks to be repeated during the treatment 18 5.3.5 * HAZARDS during the treatment . 19 5.3.6 Deviations from the treatment parameters prescribed or treatment interruption 19 5.3.7 Terminating the DIALYSIS treatment 20 5.3.8 * After completion of the dialysis treatment 20 6 Noti
13、fication of INCIDENTS . 20 7 Handling medical devices . 20 7.1 Technical service, SERVICING and checks of equipment and plants 20 7.2 * Equipment safety and device combinations . 21 7.3 Non-INTENDED USE . 21 Annex A (informative) Explanatory technical remarks . 22 Bibliography 28 Index of defined te
14、rms used in this guideline. 30 Figure 1 Example PATIENT ENVIRONMENT . 10 Figure A.1 Typical central DIALYSIS FLUID delivery system, CDDS . 26 TR 62653 IEC:2012(E) 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ GUIDELINE FOR SAFE OPERATION OF MEDICAL EQUIPMENT USED FOR HAEMODIALYSIS TREATMENTS FOREWOR
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26、ation of a technical report when it has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. IEC 62653, which is a technical report, has been prepared by subcommittee 62D: Electromedical equipment, of IEC technical com
27、mittee 62: Electrical equipment in medical practice. The text of this technical report is based on the following documents: Enquiry draft Report on voting 62D/976/DTR 62D/1006/RVC Full information on the voting for the approval of this technical report can be found in the report on voting indicated
28、in the above table. 4 TR 62653 IEC:2012(E) This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. The verbal forms used in this guideline are conform to usage described in Annex H of the ISO/IEC Directives, Part 2, 2011. For the purpose of this informative guideline the
29、 auxiliary verb ”should“ means that this statement of the guideline is recommended for safe operation. This term is not to be interpreted as indicating requirements. In this guideline the following print types are used: Requirements and definitions: roman type; Informative material, such as notes, e
30、xamples and references: smaller type; TERMS DEFINED IN THIS GUIDELINE OR AS NOTED: SMALL CAPITALS. An asterisk (*) as the first character of a title or at the beginning of a paragraph indicates that there is guidance or rationale related to that item in Annex A. The committee has decided that the co
31、ntents of this publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. A bilingual
32、version of this publication may be issued at a later date. TR 62653 IEC:2012(E) 5 INTRODUCTION HAEMODIALYSIS is a therapeutic method for treating terminal renal insufficiency, in addition to peritoneal dialysis and renal transplantation. HAEMODIALYSIS is often used as a general term for related extr
33、acorporeal methods of renal replacement therapy. At present, HAEMODIALYSIS is a standard procedure in renal replacement therapy, which, when applied properly, yields high- quality results. The treatment is a complex procedure which is under the influence of medical- biological, physical-chemical and
34、 technical processes. Numerous guidelines, agreements, codes, decrees and laws have been established with regard to HAEMODIALYSIS. They contain detailed regulations about the quality of structures, processes and results, laid down by the legislative body, executive bodies of self-government, and fun
35、ding agencies. Since the safety of PATIENT treatment and the legal provisions are highly important, it is reasonable to introduce a quality management system. This technical report may be an integral part of a quality management system of the ORGANIZATION. The ORGANIZATION should identify the residu
36、al risks, for example based on these guidelines. The ORGANIZATION should minimise such risks by the use of appropriate standard operating procedures. This document is intended to support the clinical management responsible for the quality management of HAEMODIALYSIS therapies. 6 TR 62653 IEC:2012(E)
37、 GUIDELINE FOR SAFE OPERATION OF MEDICAL EQUIPMENT USED FOR HAEMODIALYSIS TREATMENTS 1 Scope This technical report describes the technical requirements for use of equipment in HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles should be complied with to ensure safe, permissible
38、and proper application. The physician is responsible for the HAEMODIALYSIS treatment prescription. However, the ORGANIZATION administering the treatment is responsible for all resources, structures and processes used in connection with the treatment. These responsibilities will not be described here
39、. If applicable, the scope may be applicable to the use of the equipment in paediatrics, home HAEMODIALYSIS, acute and SORBENT DIALYSIS SYSTEMS. The requirements of IEC 60601-2-16 ensure that equipment used for extracorporeal renal replacement therapy operates with a high level of safety. Despite th
40、at high level of safety, however, some residual risk remains, related to medical-biological, physical-chemical and technical HAZARDS. The ORGANIZATION administering the treatment is responsible for managing the residual risk. This technical report is not intended to be used as the basis of regulator
41、y inspection or certification assessment activities. 2 Normative references None. NOTE Informative references including IEC and ISO standards are listed in the Bibliography on page 28. 3 Terms and definitions For the purpose of this document, the following terms and definitions apply. NOTE An index
42、of defined terms is found on page 30. 3.1 ACCESSORY additional part for use with equipment in order to: achieve the INTENDED USE, adapt it to some special use, facilitate its use, enhance its performance, or enable its functions to be integrated with those of other equipment Note 1 to entry: Accesso
43、ries can be objects, substances, preparations of substances and software which do not constitute any medical devices themselves. SOURCE: IEC 60601-1:2005, 3.3, modified a note to entry has been added. TR 62653 IEC:2012(E) 7 3.2 ARTERIAL PRESSURE pressure measured in the blood withdrawal line of the
44、EXTRACORPOREAL CIRCUIT Note 1 to entry: A difference can be made between the pre-pump pressure, which is upstream of the blood pump, and post-pump pressure, which is downstream of the blood pump. SOURCE: IEC 60601-2-16:2012, 201.3.201 3.3 BLOOD LEAK leakage of blood from the blood compartment to the
45、 DIALYSIS FLUID compartment of the DIALYSER Note 1 to entry: Not to be mistaken for blood loss to the environment. SOURCE: IEC 60601-2-16:2012, 201.3.202, modified the original note to entry has been replaced. 3.4 DIALYSER a device containing a semi-permeable membrane that is used to perform HAEMODI
46、ALYSIS, HAEMODIAFILTRATION or HAEMOFILTRATION SOURCE: IEC 60601-2-16:2012, 201.3.204 * 3.5 DIALYSIS FLUID aqueous fluid containing electrolytes and usually buffer and glucose, which is intended to exchange solutes with blood during HAEMODIALYSIS Note 1 to entry: The term “DIALYSIS FLUID” is used thr
47、oughout this document to mean the fluid made from DIALYSIS WATER and concentrates which is delivered to the DIALYSER by the DIALYSIS FLUID delivery system. Such phrases as “dialysate”, “dialysis solution” or “dialysing fluid” may be used in place of DIALYSIS FLUID. Note 2 to entry: The DIALYSIS FLUI
48、D entering the DIALYSER is referred to as “fresh DIALYSIS FLUID”, while the fluid leaving the DIALYSER is referred to as “spent DIALYSIS FLUID”. Note 3 to entry: DIALYSIS FLUID does not include prepackaged parenteral fluids used in some renal replacement therapies, such as HAEMODIAFILTRATION and HAE
49、MOFILTRATION. SOURCE: ISO 11663:2009, 3.7 * 3.6 DIALYSIS MACHINE HAEMODIALYSIS MACHINE HAEMODIAFILTRATION MACHINE HAEMOFILTRATION MACHINE system or combination of units used to perform HAEMODIALYSIS, HAEMODIAFILTRATION and/or HAEMOFILTRATION Note 1 to entry: The DIALYSIS MACHINE can be a batch DIALYSIS MACHINE filled with the entire DIALYSIS FLUID prior to treatment (see Clause A.6). Note 2 to entry: The DIALYSIS MACHINE can be supplied with DIALYSIS FLUID from a central DIALYSIS FLUID deliv
