1、BSI Standards Publication Medical electrical system Input interface for haemodialysis equipment for use of external alarming device PD IEC/PAS 63023:2016National foreword This Published Document is the UK implementation of IEC/PAS 63023:2016. The UK participation in its preparation was entrusted by
2、Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/4, Electromedical equipment. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a co
3、ntract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016 ISBN 978 0 580 91428 7 ICS 11.040.20 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published unde
4、r the authority of the Standards Policy and Strategy Committee on 29 February 2016. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD IEC/PAS 63023:2016 2 IEC PAS 63023:2016 IEC 2016 CONTENTS FOREWORD . 3 INTRODUCTION . 5 1 Scope 7 2 Normative references 7 3 Ter
5、ms and definitions 7 4 Application 8 4.1 Simplified circuit diagram 8 4.2 Periodic functional check 9 4.3 Condition of INPUT INTERFACE 10 4.4 Reaction of HAEMODIALYSIS EQUIPMENT 11 Bibliography 12 Figure 1 Simplified circuit diagram . 9 Table 1 Periodic functional check of the INPUT INTERFACE . 10 T
6、able 2 Reaction of HAEMODIALYSIS EQUIPMENT . 10 Table 3 Signal result of signal input to INTERNAL SIGNAL PROCESSING unit 10 Table 4 Reaction of HAEMODIALYSIS EQUIPMENT during the treatment. 11 PD IEC/PAS 63023:2016IEC PAS 63023:2016 IEC 2016 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELEC
7、TRICAL SYSTEM INPUT INTERFACE FOR HAEMODIALYSIS EQUIPMENT FOR USE OF EXTERNAL ALARMING DEVICE FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of I
8、EC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS
9、) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising wit
10、h the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as ne
11、arly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in th
12、at sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committe
13、es undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide
14、any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest
15、edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether
16、 direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indis
17、pensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. A PAS is a technical specificatio
18、n not fulfilling the requirements for a standard, but made available to the public. IEC PAS 63023 has been processed by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice The text of this PAS is based on the following document: This PA
19、S was approved for publication by the P-members of the committee concerned as indicated in the following document Draft PAS Report on voting 62D/1273/PAS 62D/1281/RVD Following publication of this PAS, which is a pre-standard publication, the technical committee or subcommittee concerned may transfo
20、rm it into an International Standard. PD IEC/PAS 63023:2016 4 IEC PAS 63023:2016 IEC 2016 This PAS shall remain valid for an initial maximum period of 3 years starting from the publication date. The validity may be extended for a single period up to a maximum of 3 years, at the end of which it shall
21、 be published as another type of normative document, or shall be withdrawn. PD IEC/PAS 63023:2016IEC PAS 63023:2016 IEC 2016 5 INTRODUCTION The effort to standardize an INPUT INTERFACE is based on the request to connect an EXTERNAL ALARMING DEVICE to the HAEMODIALYSIS EQUIPMENT in order to stop the
22、extracorporeal circuit. This PAS establishes a unique interface for connection of an EXTERNAL ALARMING DEVICE. In extracorporeal treatment different hazardous situations may occur. One major concern is blood loss to the environment. In 12.4.4.104.1 of IEC 60601-2-16:2012, different technical solutio
23、ns are given. The relevant excerpt concerning this issue from 201.12.4.4.104.1 of IEC 60601-2-16:2012 reads as follows: “a) The HAEMODIALYSIS EQUIPMENT shall include a PROTECTIVE SYSTEM to protect the PATIENT from extracorporeal blood loss to the environment that may cause a HAZARD. NOTE 1 Today no
24、system has been developed that can totally be relied upon to detect blood loss to the environment. The following recommendation is the best known system to detect blood loss to the environment. If a PROTECTIVE SYSTEM is utilizing measurement of the VENOUS PRESSURE, the OPERATOR should have at least
25、the possibility to adjust the lower ALARM LIMIT manually as closely as possible to the current measurement value. The single needle treatment mode needs additional measures. b) The HAEMODIALYSIS EQUIPMENT shall include a PROTECTIVE SYSTEM to protect the PATIENT from extracorporeal blood loss to the
26、environment caused by a rupture or separation in the EXTRACORPOREAL CIRCUIT due to excessive pressure, unless this is prevented by inherent safe design. NOTE 2 This is not related to separation of the PATIENT CONNECTION or access needle but related to the potential pressure that can be generated by
27、the pump which could cause tubing rupture or joint separation in the EXTRACORPOREAL CIRCUIT. c) Operation of the PROTECTIVE SYSTEM shall achieve thefollowing safe condition: activation of an audible and visual alarm signal (see 208.6.3.1, 208.6.3.3.2, 208.6.3.3.101: stoppage of the blood flow to the
28、 environment caused by the HAEMODIALYSIS EQUIPMENT, even under SINGLE FAULT CONDITION; in the case of HAEMOFILTRATION or HAEMODIAFILTRATION, stoppage of the SUBSTITUTION FLUID flow.” Concerning Subclause 201.12.4.4.104.1 a) of IEC 60601-2-16:2012 Monitoring of the VENOUS PRESSURE is not always suita
29、ble for detecting a blood loss in time, in case the venous puncture cannula slips out. The VENOUS PRESSURE is determined mainly by the hydraulic resistance of the venous puncture cannula, particularly with todays usual high blood flow rates of up to 500 ml/min. Hence a VENOUS PRESSURE ALARM SYSTEM i
30、s not always able to detect whether or not the puncture cannula slips out. If dialysis is performed in the single-needle mode with only one blood pump (“single-needle single pump“, “SN click-clack“), the VENOUS PRESSURE measurement is an integral part of the control system. An error in this control
31、system (e.g. pressure sensor stuck to low value) might lead to the upper changeover point of the VENOUS PRESSURE never being reached. As a result, the pressure becomes too high, the tubing system may burst, and the PATIENT may lose a great amount of blood. This may require a PROTECTIVE SYSTEM that i
32、s independent of the control system, e.g. monitoring of the phase duration by an independent microprocessor. Inherent safe design is e.g. a pump rotor that is spring-mounted so smoothly that bursting of the tubing is not possible. However, in this case the HAZARD of haemolysis may exist. PD IEC/PAS
33、63023:2016 6 IEC PAS 63023:2016 IEC 2016 Other measures for prevention of overpressure are holders for the EXTRACORPOREAL CIRCUIT lines and the DIALYSER which make kinking sufficiently unlikely. Blood loss to the environment caused by disconnections or faults in the EXTRACORPOREAL CIRCUIT cannot be
34、prevented by any PROTECTIVE SYSTEM. The PROTECTIVE SYSTEM should be designed so that blood loss is detected and major blood loss is prevented. Most reported cases of fatal blood loss are caused by blood access cannulas slipping from the fistula or graft. This cannot be prevented by the HAEMODIALYSIS
35、 EQUIPMENT. Traditionally, VENOUS PRESSURE monitors have been used for protection of blood loss to the environment. These sensors detect a drop of the pressure in the return bloodline. In case of a bloodline rupture or disconnection of the bloodline from the blood access device (cannula or central v
36、enous catheter) the pressure will drop considerably because of the high flow resistance in the blood access device. When the venous cannula slips from a fistula the pressure change is usually too low to be detected by the VENOUS PRESSURE monitor. The pressure drops only by the amount of the fistula
37、pressure, which is typically 5 mmHg 20 mmHg. To avoid frequent nuisance alarms caused by PATIENT movement the difference between the actual VENOUS PRESSURE and the lower pressure ALARM LIMIT is usually adjusted to 10 mmHg 20 mmHg. Monitors employing pressure pulses or other parameters may offer grea
38、ter sensitivity but may also require up to a minute to detect the fault condition and switch off the blood pump. With high blood flow this may cause blood losses of 500 ml, which are usually not fatal for adults. The effects of haemorrhage are described by 1 1 . Concerning Subclause 201.12.4.4.104.1
39、 c) of IEC 60601-2-16:2012 As alarm reaction, the stopping of an occluding blood pump is considered as sufficient. The additional closing of the safety clamp adds only little value, because a rupture will occur most likely at the point of highest pressure, which normally is between the blood pump an
40、d the DIALYSER. In this case “retrograde” blood loss via the venous bloodline is negligible compared to the direct blood loss through the arterial bloodline. If staff is not present (e.g. home PATIENT) or delayed for a long period, in the case of venous puncture cannula slippage, the blood loss from
41、 the venous access (backwards) may become hazardous to the PATIENT. An EXTERNAL ALARMING DEVICE could detect blood loss to the environment from venous needle disconnection. The alarm reaction of the HAEMODIALYSIS EQUIPMENT via the input interface avoids further blood loss. The solution in this PAS i
42、s given by hardware and software with regard to the behaviour of the HAEMODIALYSIS EQUIPMENT in case of activation by an EXTERNAL ALARMING DEVICE. It is the understanding of the standard committee that initially as little as possible should standardized. It is hoped that a quasi-standard evolves, wh
43、ich can then be standardized. The design of the socket and plug is under the responsibility of the manufacturers. _ 1Numbers in square brackets refer to the Bibliography. PD IEC/PAS 63023:2016IEC PAS 63023:2016 IEC 2016 7 MEDICAL ELECTRICAL SYSTEM INPUT INTERFACE FOR HAEMODIALYSIS EQUIPMENT FOR USE
44、OF EXTERNAL ALARMING DEVICE 1 Scope This PAS establishes a unique INPUT INTERFACE for connection of an EXTERNAL ALARMING DEVICE to HAEMODIALYSIS EQUIPMENT. The INPUT INTERFACE of the HAEMODIALYSIS EQUIPMENT is designed as a simple solution, which takes a SINGLE FAULT CONDITION of the INPUT INTERFACE
45、 into account, to stop the extracorporeal blood flow in case of needles slipping out from the fistula or graft detected by the EXTERNAL ALARMING DEVICE. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its appl
46、ication. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60601-2-16:2012, Medical electrical equipment Part 2-16: Particular requirements for the basic safety and essential performance
47、 of haemodialysis, haemodiafiltration and haemofiltration equipment. 3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 60601-2-16:2012 as well as the following terms and definitions apply: Additions: 3.1 EXTERNAL ALARMING DEVICE ACCESSORY that detects
48、ALARM CONDITIONS 3.2 INPUT INTERFACE part of HAEMODIALYSIS EQUIPMENT providing the possibility of access to an EXTERNAL ALARMING DEVICE. 3.3 INTERNAL SIGNAL PROCESSING part of HAEMODIALYSIS EQUIPMENT intended to process signals 3.4 SIGNAL PLUG TERMINAL DEVICE of the EXTERNAL ALARMING DEVICE for the
49、connection to the HAEMODIALYSIS EQUIPMENT SIGNAL SOCKET 3.5 SIGNAL SOCKET TERMINAL DEVICE of the INPUT INTERFACE PD IEC/PAS 63023:2016 8 IEC PAS 63023:2016 IEC 2016 3.6 HAEMODIALYSIS EQUIPMENT GROUND grounding terminal connected to conductive parts for INTERNAL SIGNAL PROCESSING 3.7 SIGNAL GROUND grounding terminal connected to conductive parts for external signal processing 4 Application 4.1 Simplified circuit diagram The simplified circuit diagram in Figure 1 provides a hardware solution for
