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BRITISH STANDARD BS EN EN 60601-1-10:2008 60601-1-10:2008 +A1:2015 Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop controllers ICS 11.040.10             BS EN 60601-1-10:2008+A1:2015 National foreword This British Standard is the UK implementation of EN 60601-1-10:2008+A1:2015 It is identical to IEC 60601-1-10:2007 incorporating amendment 1:2013 It supersedes BS EN 60601-1-10:2008, which will be withdrawn on 31 December 2018 The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to IEC text carry the number of the IEC amendment For example, text altered by IEC amendment is indicated by  The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice to Subcommittee CH/62/1, Common aspects of Electrical Equipment used in Medical Practice A list of organizations represented on this subcommittee can be obtained on request to its secretary This publication does not purport to include all the necessary provisions of a contract Users are responsible for its correct application Compliance with a British Standard cannot confer immunity from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 August 2008 © The British Standards Institution 2015 Published by BSI Standards Limited 2015 ISBN 978 580 80619 Amendments/corrigenda issued since publication Date Comments 30 June 2015 Implementation of IEC amendment 1:2013 with CENELEC endorsement A1:2015 Annex ZA updated ENEN 60601-1-10:2008+A1 60601-1-10 EUROPEAN STANDARD NORME EUROPÉENNE MayApril 20152008 EUROPÄISCHE NORM ICS 11.040 English version Medical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007) Appareils électromédicaux Partie 1-10: Exigences générales pour la sécurité de base et les performances essentielles Norme collatérale: Exigences pour le développement des régulateurs physiologiques en boucle fermée (CEI 60601-1-10:2007) Medizinische elektrische Geräte Teil 1-10: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale Ergänzungsnorm: Anforderungen an die Entwicklung von physiologischen geschlossenen Regelkreisen (IEC 60601-1-10:2007) This European Standard was approved by CENELEC on 2008-03-01 CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member This European Standard exists in three official versions (English, French, German) A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels © 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members Ref No EN 60601-1-10:2008 E BS EN 60601-1-10:2008+A1:2015 -2–2– BS EN 60601-1-10:2008 Foreword The text of document 62A/576/FDIS, future edition of IEC 60601-1-10, prepared by SC 62A, Common aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical practice, and ISO SC 1, Breathing attachments and anaesthetic machines, and SC 3, Lung ventilators and related devices, of ISO TC 121, Anaesthetic and respiratory equipment, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-1-10 on 2008-03-01 The following dates were fixed: – latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2008-12-01 – latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2011-03-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC See Annex ZZ This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as the general standard In the 60601 series of publications, collateral standards specify general requirements for safety applicable to: – a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g radiological equipment); or – a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general standard (e.g ALARM SYSTEMS) In this collateral standard, the following print types are used: − requirements and definitions: in roman type; − test specifications: in italic type; − informative material appearing outside of tables, such as notes, examples and references: in smaller type Normative text of tables is also in a smaller type; − TERMS DEFINED IN CLAUSE OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: IN SMALL CAPITALS In referring to the structure of this standard, the term – “clause” means one of the eight numbered divisions within the table of contents, inclusive of all subdivisions (e.g Clause includes Subclauses 8.1, 8.2, etc.); – “subclause” means a numbered subdivision of a clause (e.g 8.1, 8.2 and 8.2.1 are all subclauses of Clause 8) References to clauses within this standard are preceded by the term “Clause” followed by the clause number References to subclauses within this standard are by number only In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true -3–3– BS EN 60601-1-10:2008+A1:2015 BS EN 60601-1-10:2008 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part For the purposes of this standard, the auxiliary verb − “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; − “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; − “may” is used to describe a permissible way to achieve compliance with a requirement or test Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*) Annexes ZA and ZZ have been added by CENELEC Endorsement notice The text of the International Standard IEC 60601-1-10:2007 was approved by CENELEC as a European Standard without any modification EN 60601-1-10:2008/A1:2015 ForewordForeword to amendment A1 The text of document 62A/888/FDIS, future IEC 60601-1-10:2007/A1, prepared by SC 62A "Common aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in medical practice" and ISO/SC "Breathing attachments and anaesthetic machines" and ISO/SC "Lung ventilators and related devices" of ISO/TC 121 "Anaesthetic and respiratory equipment" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-1-10:2008/A1:2015 The following dates are fixed: • latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-01-14 • latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-12-31 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-1-10:2008 Endorsement notice The text of the International Standard IEC 60601-1-10:2007/A1:2013 was approved by CENELEC as a European Standard without any modification EN 60601-1-10:2008/A1:2015 Normative references to international publications with their corresponding publications AnnexEuropean ZA EN 60601-1-10:2008/A1:2015 (normative) BS EN 60601-1-10:2008+A1:2015 The following documents, in whole or in part, are normatively referenced in this document and are EN 60601-1-10:2008/A1:2015 – 39 – only the editionBS EN 60601-1-10:2008 indispensable for its application For dated references, cited applies For undated Annex ZA Normative to international publications references, the latest edition of references the referenced document (including any amendments) applies (normative) Annex ZA with their corresponding European publications Annex ZA NOTE When an International Publication has been modified by common modifications, indicated by (mod), the relevant (normative) (normative) EN/HD applies The following documents, in whole or in part,to areinternational normatively referenced in this document and are Normative references publications indispensable forinformation itsNormative application For dated references, only the edition cited undated NOTE Up-to-date on thecorresponding latest versions of the European Standards listed in thisapplies annex is For available here: with their European publications referencestotointernational international publications publications Normative www.cenelec.eu references, the latest edition of references the referenced document (including any amendments) applies with their correspondingEuropean European publications publications with their corresponding The following documents, in whole or in part, are normatively referenced in this document and are NOTE When an International Publication been modified by common modifications, indicated by (mod), the relevant Modifications ZA For ofhas EN 60601-1-10:2008: indispensable for in its Annex application dated references, only the edition cited applies For undated The EN/HDfollowing applies referenced documents are indispensable for the application of this document For dated The following documents, inofwhole or in part,document are normatively referenced in this document and are references, edition the applies referenced references, the onlylatest the edition cited For undated (including references,any theamendments) latest editionapplies of the referenced indispensable for its application For dated references, only the edition cited applies ForYear undated Publication Year Title EN/HD NOTE Up-to-date information on the latest versions document (including any amendments) applies.of the European Standards listed in this annex is available here: references, edition of the referenced document (including any amendments) www.cenelec.eu NOTE Whenthe an latest International Publication has been modified by common modifications, indicated by applies (mod), the relevant EN/HD applies Replace the IEC 60601-1, IEC modifications, 60601-1-6 indicated and IEC by EN/HD NOTE When an existing international references publication has to been modified by common by 60601-1-8 (mod), the relevant NOTE When an International Publication has been modified by common modifications, indicated by (mod), the relevant Modifications in Annex ZA of EN 60601-1-10:2008: applies the references: NOTEfollowing 2applies Up-to-datenew information on the latest versions of the European Standards listed in this annex is available here: EN/HD www.cenelec.eu Publication Year on Title EN/HD Year EN/HD Year NOTE Up-to-date information the latestelectrical versions ofequipment the European this annex is available here: IEC 60601-1 2005 Medical - Standards listed ENin 60601-1 2006Year www.cenelec.eu IEC 60601-1 2005 Medical electrical equipment -for basic EN 60601-1 Part 1: General requirements + corr March 20102006 Modifications in Annex ZA of EN 60601-1-10:2008: Part 1:and General basic safety Replace the existing references to essential IEC requirements 60601-1, IECfor60601-1-6 and IEC 60601-1-8 by safety performance and performance Modifications in2012 Annex ZAessential of EN 60601-1-10:2008: +A1 the following new references: Publication Year Title +A1 2013 EN/HD Year +A1/AC IEC 60601-1-6 2006 Medical electrical equipment EN 60601-1-6 20142007 Publication Year Title Year IEC 60601-1 2005references Medical equipment - 60601-1-6 EN 2006 Part 1-6:electrical General requirements for basic EN/HD Replace the existing to IEC 60601-1, IEC and60601-1 IEC 60601-1-8 by +A12 2014 Part 1: General requirements for basic + corr March 2010 safety and essential performance Collateral the following new references: Replace the existing references toUsability IEC 60601-1, IEC 60601-1-6 and IEC 60601-1-8 by safety and essential performance Standard: IEC 60601-1-6 2010 Medical electrical equipment EN 60601-1-6 2010 the following new references: +A1 2012 +A160601-1 2013 IEC 2005 Medical equipment Part 1-6:electrical General requirements IEC 60601-1 60601-1-8 2006 Medical electrical equipment for basic ENEN 60601-1-8 20062007 +A1/AC 2014 Part General requirements forfor basic 2010 safety and essential performance - basic + corr March Part 1: 1-8: General requirements IEC 60601-1 2005 Medical electrical equipment EN 60601-1 2006 safety and essential performance Collateral safety andstandard: essential Usability performance - Collateral +A12 2014 Part 1: General requirements for basic + corr March 2010 +A1 2012 2013 2013 2015 Standard: General requirements, tests and +A1 safety and essential performance +A1/AC 2014 guidanceelectrical for alarmequipment systems in- medical IEC 60601-1-6 2010 Medical EN 60601-1-6 2010 +A1 2012 +A1 2013 IEC 60601-1-8 2006 Medical equipment - forelectrical 60601-1-8 2007 electrical equipment and medical Part 1-6:electrical General requirements basic EN +A12 2014 +A1/AC 2014 Part 1-8: General requirements for- basic + corr March 2010 systems safety and essential performance safety and essential performance +A12 2014 Collateral standard: Usability IEC 62304 60601-1-6 2010 Medical electrical equipment EN 60601-1-6 20102006 2006 device software - Software life-cycle EN 62304 Collateral Standard: General requirements, +A1 2013 +A1 2015 Part 1-6: General requirements for basic processes tests guidance for alarm -systems in IEC 60601-1-6 2010 Medical electrical equipment EN 60601-1-6 2010 safetyand and essential performance 1) 2) ISO 14971 Medical devices - requirements Applicationand of riskbasic ENEN ISO 14971 20072007 medical equipment Part 1-6:electrical General IEC 60601-1-8 2006 Medical 60601-1-8 Collateral standard: Usability - formedical management to medical devicesfor- basic + corr March electrical systems safety and essential performance Part 1-8: General requirements 2010 +A1 2013 +A1 2015 +A1 2012 +A1 2013 Collateral safety andstandard: essential Usability performance +A1/AC 2014 +A1 2013 +A1 2015 Collateral Standard: General requirements, IEC 60601-1-8 2006 Medical electrical equipment EN 60601-1-8 2007 tests and guidance for alarm systems in Part 1-8: General requirements for basic + corr March 2010 medical and medical IEC 60601-1-8 2006 Medical electrical equipment EN 60601-1-8 2007 safety and essential performance Delete the following reference: electrical systems Part 1-8: General requirements for basic + corr March 2010 Collateral Standard: General requirements, +A1 2012 +A1 2013 safety andguidance essentialfor performance tests and alarm systems in IEC 62304 2006 Medical device software - Software lifeEN 62304 2006 +A1/AC 2014 Collateral Standard: General and requirements, medical electrical equipment medical cycle processes tests and guidance for alarm systems in electrical systems ISO 14971 - 1) Medicalelectrical devices equipment - Application risk EN ISO 14971 2007 2) medical andofmedical +A1 2012 +A1 2013 Delete the following reference: Add the following reference: management to medical devices electrical systems +A1/AC 2014 +A1 2012 +A1 2013 IEC 62304 2006 Medical device - Software lifeEN 62304 2006 62366 2007 devicessoftware - Application of usability 62366 2008 +A1/AC 2014 cycle processes engineering to medical devices Delete the following reference: Delete following reference: Add62304 thethe following reference: IEC 2006 Medical device software - Software life- cycle processes IEC 62304 2006 Medical device - Software life62366 2007 devicessoftware - Application of usability cycle processes engineering to medical devices Add the following reference: EN 62304 2006 EN 62304 62366 2006 2008 Add the following2007 reference: IEC 62366 Medical devices - Application of usability EN 62366 2008 IEC 62366 EN 62366 2008 1) 2) 2007 Undated reference engineering to medical devices Medical devices - Application of usability engineering to medical devices 3 Valid edition at date of issue 3 BS EN 60601-1-10:2008 -5– 40 – BS EN 60601-1-10:2008+A1:2015 Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard - 25 – 23 – BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 BS EN 60601-1-10:2008 For example, a critical care ventilator minute volume (number of breaths per minute multiplied by the expiratory volume) can be determined by a PCLC in response to the PHYSIOLOGIC VARIABLES end-tidal CO and airway pressure The OPERATOR sets the target end-tidal CO to 30 mmHg and the allowable range of peak airway pressures from 15 cmH O to 35 cmH O The PCLC sets the expiratory volume and ventilation rate An example of a PCLCS where the COMMAND VARIABLE changes over time is one in which the OPERATOR sets the target end-tidal CO to increase linearly from 25 mmHg to 45 mmHg over a 30 period There are also instances when the OPERATOR will gradually decrease the COMMAND VARIABLE to wean the PATIENT from the medication (for example to slowly awaken a PATIENT from a drug-induced coma) Definition 3.5 – COMPARING ELEMENT The COMPARING ELEMENT can consist of a simple subtraction, a classification within a value range up to a complex relationship resulting from neural network calculation The resulting comparison result is used by the CONTROL TRANSFER ELEMENT for calculation of the CONTROLLER OUTPUT VARIABLE Definition 3.8 – DISTRIBUTED PCLCS In a typical PCLCS , the PCLC , the ACTUATOR and the MEASURING TRANSFER ELEMENTS are all contained within a single piece of ME EQUIPMENT A typical example would be a stand-alone end-tidal-anaesthetic agent-controlled anaesthesia workstation In a DISTRIBUTED PCLCS , at least one of the following elements: MEASURING TRANSFER ELEMENT is located in a separate piece ME SYSTEM a PCLC , an ACTUATOR , or a of equipment forming an In a DISTRIBUTED PCLCS , one of the following takes place in different parts of the ME SYSTEM : – the processing of the ERROR VARIABLE and generation of the CONTROLLER OUTPUT VARIABLE ; – the processing of the PHYSIOLOGIC VARIABLE ; or – generation of MANIPULATED VARIABLE Definition 3.9 – DISTURBANCE VARIABLE From the viewpoint of the PCLC , DISTURBANCE VARIABLES are independent and frequently unpredictable events that can occur to parts of the PCLCS Consider the following example for a PCLC controlling invasive blood pressure using an infusion of a drug The PATIENT TRANSFER ELEMENT is the PATIENT ' S blood pressure response to an infused drug D ISTURBANCE VARIABLES can include sources of interference with the measurement, as well as PATIENT DISTURBANCE VARIABLES such as other sources of actual blood pressure changes See also the rationale for PATIENT DISTURBANCE VARIABLE Examples of DISTURBANCE VARIABLES acting on the PCLCS controlling blood pressure include: – flushing the arterial line; – turning the three-way stopcock so that the arterial line is obstructed; – damping of the waveform due to catheter kinking Definition 3.11 – FALLBACK MODE The committee had difficulty deciding the term for this definition Alternate terms that were considered included secondary mode, fail-safe mode, and safety mode “Safety mode” and BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 BS EN 60601-1-10:2008 - 26 – 24 – “fail-safe” were discarded as this mode is really “not as safe” a mode as when the PCLC is functioning optimally The term “secondary mode” may be construed as an alternate acceptable path in an algorithm in response to certain values of the PHYSIOLOGIC VARIABLE These terms were discarded in favour of FALLBACK MODE as they had different definitions in other standards and in common daily use A SINGLE FAULT CONDITION , such as timing out of an algorithm or the PCLC not being able to appropriately respond to the PHYSIOLOGIC VARIABLE (e.g out of range), can initiate the FALLBACK MODE There are several methods used to implement the FALLBACK MODE of a PCLCS These methods include, but are not limited to: – stopping the PCLC ; – setting the CONTROLLER OUTPUT VARIABLE to a safe value; or – going into open loop control and notifying the OPERATOR to manually adjust the ACTUATOR The method of FALLBACK MODE used for a particular PCLCS is determined by RISK ANALYSIS If the RESIDUAL RISK of any FALLBACK MODE of a PCLCS is not acceptable, then the PCLCS should be forbidden Definition 3.17 – PATIENT DISTURBANCE VARIABLE A PATIENT DISTURBANCE VARIABLE is a subset of DISTURBANCE VARIABLES that can either arise from inside the PATIENT (e.g a cough or a fever) or from outside the PATIENT (e.g tilting the PATIENT ’ S bed, thereby effecting the PATIENT ’ S blood pressure or administering another drug) Consider the following example for a PCLC controlling invasive blood pressure using an infusion of a drug The PATIENT TRANSFER ELEMENT is the PATIENT ' S blood pressure response to an infused drug PATIENT DISTURBANCE VARIABLES include other sources of actual blood pressure changes Examples of PATIENT DISTURBANCE VARIABLES acting on the PATIENT TRANSFER ELEMENT include: – administration of another drug that changes blood pressure; – rapid blood loss; – desensitizing to the administered drug; – cyclic-respiration-induced blood pressure changes Definition 3.20 – PHYSIOLOGIC CLOSED - LOOP CONTROLLER P HYSIOLOGIC CLOSED - LOOP CONTROLLERS use feedback from a PHYSIOLOGIC VARIABLE to adjust the PHYSIOLOGIC VARIABLE to a COMMAND VARIABLE Many such controllers can be thought of as therapeutic controllers because they are being used to control the flow of energy or substances to a PATIENT for therapeutic purposes The committee chose to not use "therapeutic" in the defined term because these controllers could also be used to control the delivery of non-therapeutic agents such as anaesthetic agents Definition 3.22 – REFERENCE VARIABLE Since the COMMAND VARIABLE can vary over time, it is obvious that the REFERENCE VARIABLE can also vary over time Additionally, the COMMAND TRANSFER ELEMENT can transform a static COMMAND VARIABLE into a REFERENCE VARIABLE that changes with time For example, a PCLC is controlling the delivery of a drug that could have adverse events if delivered rapidly The OPERATOR enters a new fixed COMMAND VARIABLE Under this circumstance, the COMMAND TRANSFER ELEMENT converts the fixed value into a time-varying –- 27 25 –– 25 – REFERENCE VARIABLE REFERENCE VARIABLE COMMAND VARIABLE COMMAND VARIABLE BS EN 60601-1-10:2008+A1:2015 IECBS 60601-1-10:2007+A1:2013 EN 60601-1-10:2008 BS EN 60601-1-10:2008 that slowly increases to the desired value set by the OPERATOR as the that slowly increases to the desired value set by the OPERATOR as the Clause – General requirements Clause – General requirements – latency times – latency times Latency times can present a HAZARD to PATIENTS by causing a PCLC to become unstable or to PATIENTS byand causing a PCLC to become unstable or Latency times can present a HAZARD slow to respond There are many sources of latency they need to be accounted for in the slow to of respond There many of latency and they need to be accounted in the Theare PCLC , thesources ACTUATOR and particularly the PATIENT TRANSFER for ELEMENT design the PCLC PCLC The PCLC , the ACTUATOR the PATIENT TRANSFER ELEMENT design of the VARIABLES and can particularly also affect latency are subject to latency D ISTURBANCE are subject to latency D ISTURBANCE VARIABLES can also affect latency – DISTRIBUTED PCLCS – DISTRIBUTED PCLCS Parameters that should be considered for a DISTRIBUTED Parameters that should beofconsidered for a DISTRIBUTED transmission, availability data, compatibility of data transmission, availability of data, compatibility of data integrity integrity PCLCS include PCLCS include formats, data delay time for delay timeand for security formats, data security and data data data data Sublause 5.1 – Instructions for use Sublause 5.1 – Instructions for use A mental model is an OPERATOR ' S conceptual model of how the PCLCS works and is structured OPERATOR PCLCS conceptual model howthe the worksand andis isstructured structured A model 'is is an operator model ofofhow If S an mental model’ s' Sisconceptual based on model the knowledge of pclcs why aworks PCLCS works in a certain If mental the OPERATOR OPERATOR ' S mental model is based on the knowledge of why a PCLCS works in a certain If the the operator ’ s mental model is based on the knowledge of why a pclcs works in a certain way, way, it is a structured model and allows the OPERATOR to solve problems that might ariseit to solve might way, it the is ause structured model is a structured model and allows the allows operator toOPERATOR solve' Sproblems thatproblems might during thearise use PCLCS and Ideally, an the OPERATOR mental model canarise bethat easily created during of the PCLCS Ideally, an OPERATOR ' S mental model can be easily created during the use of the of the pclcs Ideally, an operator ’ s mental model can be easily created through interaction with through interaction with the PCLCS or it can be acquired through explanation from TRAINING TRAINING or itexplanation can DOCUMENTS be acquired through from  through with the the pclcs or it can be acquired through from  training (see IECmodels 62366) orselfthe ACCOMPANYING The bestexplanation mental are (see IECinteraction 60601-1-6) or the PCLCS ACCOMPANYING DOCUMENTS The best and mental are self(see IEC 60601-1-6) or the accompanying documents The best mental models are self-evident needmodels no explanation evident and need no explanation evident and need no explanation The mental model of how a sodium nitroprusside blood pressure controller maintains PATIENT PATIENT The mental model of how blood pressure controller maintains to a clinical situation When the OPERATOR responds blood pressure can affecta sodium how an nitroprusside responds to a clinical situation When the OPERATOR blood pressure can affect how an OPERATOR evaluates the PATIENT , the blood pressure is too high The proper clinical response OPERATOR evaluates the PATIENT , the blood pressure is too high The proper clinical response is dependent upon which of the two possibilities is, in fact, occurring is dependent upon which of the two possibilities is, in fact, occurring – The PCLC is in ‘learning mode’ and is determining the sensitivity of the PATIENT to sodium determining the sensitivity of theinfusing PATIENT while to sodium – nitroprusside The PCLC is in ‘learning is deliberately under the In this mode’ mode, and theis PCLCS PCLCS is deliberately under infusing while the nitroprusside In this mode, the determination is being made determination is being made – The PCLC is in ‘normal mode’ and the PATIENT is not appropriately responsive to the drug – The PCLC is in ‘normal mode’ and the PATIENT is not appropriately responsive to the drug An anaesthesia workstation has target-controlled anaesthetic delivery capability, in which An anaesthesia hasa target-controlled anaesthetic in which PATIENT to control PATIENT capability, end-tidal delivery anaesthetic agent volatile agent isworkstation delivered to PATIENT PATIENT to control end-tidal anaesthetic agent volatile agent is delivered to a the concentration These two scenarios illustrate how a mental model of the PCLCS can help PCLCS can help the concentration These two scenarios illustrate how a mental model of the OPERATOR to overcome a problem and avoid PATIENT injury OPERATOR to overcome a problem and avoid PATIENT injury – An empty reservoir of anaesthetic agent hinders the PCLC from maintaining the desired from maintaining – An reservoir of agent thebyPCLC or washedthe outdesired of the doseempty of anaesthetic as anaesthetic the anaesthetic is hinders consumed the PATIENT PATIENT or washed of the dose of anaesthetic as the anaesthetic is consumed by the system is circuit by excess fresh gas flow If the OPERATOR is aware that the breathing out OPERATOR is aware that the breathing system circuit by excess fresh gas flow If the operating in a very low flow closed circle breathing system and therefore that it will take is a operating in a very flowconcentration closed circle falls breathing and thereforethe that it will take a OPERATOR can long time before thelow agent under system a critical threshold, long time before the agent concentration a critical threshold, the OPERATOR react in an unhurried fashion to refill falls the under anaesthetic agent reservoir or changecan to react in an unhurried fashion to refill the anaesthetic agent reservoir or inhibit change the to intravenous anaesthetics Awareness of the mode of operation can also intravenousfrom anaesthetics Awareness of the inmode of concentration operation can alsocan inhibit OPERATOR setting non-essential changes oxygen which resultthe in OPERATOR from setting non-essential in oxygen concentration which can result in a change to a high flow open modechanges of breathing system operation that would abruptly a change to a high flow open mode of breathing system operation that would abruptly decrease anaesthetic agent concentration decrease anaesthetic agent concentration – The expiratory agent concentration is measured by a side-stream sensor at the Y-piece If – The expiratory concentration is measured by a side-stream sensor the Y-piece If goes into the sample lineagent is blocked, this condition is recognized as a fault and theatPCLCS PCLCS goes into the sample line is blocked, this condition is recognized as a fault and the FALLBACK MODE In this mode, only the concentration of anaesthetic agent in the fresh gas FALLBACK MODE In this mode, only concentration of anaesthetic agentinin the the breathing fresh gas flow is controlled, which leads to the a decrease of agent concentration decrease of agent concentration in the breathing flow is controlled, which leads to a system In this situation, the OPERATOR needs to be aware of the operational mode change OPERATOR needs in to the be aware of the operational mode change system In thistosituation, and the need increase the agent concentration fresh gas flow to maintain anaesthetic and the need to increase agent concentration in the fresh gas flow to maintain anaesthetic depth depth BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 BS BS EN EN 60601-1-10:2008 60601-1-10:2008 - 28 – – 26 26 – – Sublause Sublause 6.1 6.1 – – USABILITY USABILITY needs the ability OPERATOR operator needs pclcs consistent OPERATOR needs the the ability ability to to maintain maintain awareness awareness of of the the status status of of the the PCLCS PCLCS consistent OPERATOR ' S mental model of the PCLCS (see IEC 60601-1-6) A mental the IEC60601-1-6) 62366  ).AA mental mental model model is is an OPERATOR’'sS mental mental model model ofofthe thepclcs PCLCS(see (see IEC model is an the operator OPERATOR ' S conceptual model of how the PCLCS works and is structured If the OPERATOR operator ’'sS conceptual pclcs works and is structured structured IfIf the the OPERATOR operator ''’S s OPERATOR conceptual model of how the PCLCS S works in certain it mental model based knowledge of why a onon thethe knowledge of why pclcs works in a certain it is way, a structured PCLCS works in a a way, certain way, it is is a a mental model model isis isbased based on the knowledge of a why a PCLCS to problems that might arise during use structured allows model and model allows and the operator solve problems that might arise use of thethe pclcs OPERATOR to solve solve problems thatduring might the arise during the use structured model and allows the thetoOPERATOR PCLCS Ideally, an OPERATOR ' S mental model can be easily created through interaction of the Ideally, an operator mental model' Scan be easily created with the pclcs or Ideally,’ s an OPERATOR mental model can bethrough easily interaction created through interaction of the PCLCS PCLCS TRAINING ACCOMPANYING or can acquired explanation or with or the the document ACCOMPANYING or it it can be beexplanation acquired through through explanation from with the it canthe be PCLCS acquired through from  training  from or theTRAINING accompanying The The best mental models are self-evident and need no explanation DOCUMENT The best mental models are self-evident and need no explanation DOCUMENT best mental models are self-evident and need no explanation The The with with The COMMAND VARIABLE VARIABLE or REFERENCE or REFERENCE The ability ability to to monitor monitor the the mode mode of of operation operation as as well well as as the the COMMAND , CONTROLLER OUTPUT VARIABLE or MANIPULATED VARIABLE , and PHYSIOLOGIC VARIABLE VARIABLE VARIABLE , CONTROLLER OUTPUT VARIABLE or MANIPULATED VARIABLE , and PHYSIOLOGIC VARIABLE or or FEEDBACK FEEDBACK VARIABLE VARIABLE facilitates facilitates appropriate appropriate OPERATOR OPERATOR supervision supervision of of the the PCLCS PCLCS This This enables enables the OPERATOR to to diagnose diagnose a a PCLCS PCLCS deviation deviation and and to to make make informed informed decisions decisions and and take take the OPERATOR corrective OPERATOR to to understand understand the the corrective action action To To build build a a mental mental model, model, it it is is important important for for the the OPERATOR targets VARIABLES of of the the PCLC PCLC targets and and the the internal internal VARIABLES EXAMPLE EXAMPLE In the COMMAND In the the first first period period after after changing changing the COMMAND VARIABLE VARIABLE ,, it it can can be be normal normal to to observe observe a a high high without without observing observing a a change change in in the the PHYSIOLOGIC PHYSIOLOGIC VARIABLE VARIABLE The The with with his his expected expected RESPONSE RESPONSE TIME TIME based based on on his his mental mental model model to to decide decide whether whether something something is is going going wrong wrong or or not not MANIPULATED MANIPULATED VARIABLE VARIABLE (e.g (e.g dosing dosing rate rate of of a a drug) drug) OPERATOR OPERATOR compares compares the the RESPONSE RESPONSE TIME TIME of of the the PCLC PCLC Particular consider defining defining specific specific requirements requirements regarding regarding continuous continuous or or Particular standards standards should should consider continual display display of of certain certain VARIABLE VARIABLE values values or or modes modes of of operation operation continual Subclause CLC VARIABLE VARIABLE logging logging Subclause 6.3 6.3 – –P P CLC The OPERATORS or or SERVICE SERVICE PERSONNEL PERSONNEL to to perform perform The purpose purpose of of this this requirement requirement is is to to allow allow OPERATORS analysis analysis of of incidents incidents or or unexpected unexpected clinical clinical or or equipment equipment behaviours behaviours The The logs logs should should be be capable capable of of being being retained retained for for sufficient sufficient time time to to permit permit access, access, should should the the need need occur occur The The log log can can be be useful useful for for several several reasons: reasons: – – – – – – – – to to determine determine the the cause cause of of transient transient behaviours; behaviours; to ME EQUIPMENT EQUIPMENT or or ME ME SYSTEM SYSTEM is is to determine determine the the cause cause of of unexpected unexpected behaviours behaviours when when the the ME unattended OPERATOR in in NORMAL NORMAL USE USE ;; unattended by by an an OPERATOR for quality quality assurance assurance purposes; for purposes; or or for for the the study study of of critical critical incidents, incidents, similar similar to to the the event event logging logging of of aircraft aircraft "black-boxes" "black-boxes" Means ME EQUIPMENT EQUIPMENT or or ME ME SYSTEM SYSTEM or or remotely remotely Means for for logging logging can can be be provided, provided, either either within within the the ME through a communications interface The contents of the log can be stored either through a communications interface The contents of the log can be stored either for for a a SERVICE PERSONNEL or OPERATOR action specified period of time or until deleted by The specified period of time or until deleted by SERVICE PERSONNEL or OPERATOR action The contents should be be available available for for review review by by the the OPERATOR OPERATOR Short Short losses losses of of power power contents of of the the log log should (less (less than than 30 30 s) s) should should not not cause cause the the loss loss of of the the contents contents of of the the log log The OPERATOR indicates indicates to to the the The previously previously stored stored contents contents of of the the log log can can be be deleted deleted when when the the OPERATOR ME EQUIPMENT or ME SYSTEM , preferably through an “admit new PATIENT " function, that ME EQUIPMENT or ME SYSTEM , preferably through an “admit new PATIENT " function, that a a different PATIENT has has been been connected connected to to the the ME ME EQUIPMENT EQUIPMENT or or ME ME SYSTEM SYSTEM M M ANUFACTURERS ANUFACTURERS different PATIENT should OPERATOR action action for for servicing servicing and and should consider consider including including a a log log that that cannot cannot be be reset reset by by OPERATOR maintenance purposes maintenance purposes Subclause 6.4 – –D D ISTRIBUTED ISTRIBUTED PCLCS PCLCS Subclause 6.4 in its its infancy infancy New The DISTRIBUTED PCLCS PCLCS is is in New ideas ideas and and new new technology technology are are The application application of of DISTRIBUTED bringing rapid the field field was was bringing rapid advances advances and and changes changes in in this this area area The The committee committee believed believed that that the too too immature immature to to write write a a large large number number of of specific specific requirements requirements Perhaps Perhaps a a future future edition edition of of this this collateral when the the technology technology has has collateral standard standard will will be be able able to to include include more more specific specific requirements requirements when matured In In the the meantime, meantime, a a MANUFACTURER MANUFACTURER is is left left to to use use RISK RISK ANALYSIS ANALYSIS to to be be sure sure that that the the matured DISTRIBUTED PCLCS serves its primary purpose while maintaining PATIENT safety DISTRIBUTED PCLCS serves its primary purpose while maintaining PATIENT safety –- 29 27 –- BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 – – – 27 27 SYSTEMS – Clause – P ROGRAMMABLE ELECTRICAL MEDICAL ( PEMS ) BS EN 60601-1-10:2008 BS BS EN EN 60601-1-10:2008 60601-1-10:2008 Rather it is hoped that It isClause not the of this duplicationstandard of PROCESSES  7intent of the first clause editionto ofrequire this collateral applied the requirements of Clause Clause 7– –P P ROGRAMMABLE ROGRAMMABLE ELECTRICAL ELECTRICAL MEDICAL MEDICAL SYSTEMS SYSTEMS (( PEMS PEMS )) utilizes common PROCESSES PEMS its subsystems including for This the MANUFACTURER IEC 62304:2006 to the software elements of the pems wasand in addition to the requirement software of Clause 14intent of theof standard Amendment to of thePROCESSES general standard the Rather it It is not this to duplication PROCESSES Rather incorporates it is is hoped hoped that that It is not the the intent ofgeneral this clause clause to require require duplication of software process requirements into Clause 14 Therefore, the additional requirements in MANUFACTURER utilizes common PROCESSES PEMS and its subsystems including for the the MANUFACTURER utilizes common PROCESSES for PEMS and its subsystems including software Clause 7 this–collateral Subclause General standard are redundant and can, in effect, be deleted  software of 8.1 Compliance 8.1 with General the PCLCS development PROCESS of this collateral standard requires that a Subclause Subclause 8.1 – – General series of development activities be performed It does not require that any particular life cycle model is used, but it pclcs does require that the activities included have certain attributes These Compliance process of PCLCS development development PROCESS PROCESS of this this collateral collateral standard standard requires requires that that a a Compliance with with the the PCLCS requirements in IEC 60601-1 for development life PEMS requirements are similar to the cycle series series of of development development activities activities be be performed performed It It does does not not require require that that any any particular particular life life cycle, cycle and requirement specification, architecture, and implementation, model is but that activities included have attributes model is used, used, but it it does does require require that the thedesign activities included have certain certainVERIFICATION attributes ,These These requirements in this collateral standard provide greater details about VALIDATION The PCLCS PEMS requirements in IEC 60601-1 for development life cycle, requirements are similar to the requirements in  the general  for development requirements in IEC 60601-1standard for development life cycle, PEMS requirements are are similar similartotothe thepems development than those in the IEC 60601-1 or IEC 62304 VERIFICATION ,, , and requirement specification, architecture, design and implementation, life cycle, requirement specification, architecture, design implementation, verification VERIFICATION and requirement specification, architecture, design and and implementation, VALIDATION The requirements in this collateral standard provide greater details about validation pclcs The requirements requirements in in this this collateral collateral standard provide greater details about PCLCS VALIDATION The PCLCS development than those those in SYSTEMS the  IEC 60601-1 or 62304 ME EQUIPMENT or ME that incorporate a PCLC can also operate without using the When IECgeneral 60601-1 or IEC IEC  62304 development than in the standard PCLC , it is important for the OPERATOR to distinguish between the following modes: ME EQUIPMENT or ME that incorporate incorporate a a PCLC can also also operate operate without without using using the the When EQUIPMENT or ME SYSTEMS SYSTEMS that PCLC can When places the or ME SYSTEM deliberately intomodes: a non- PCLC mode, OPERATOR ME EQUIPMENT – theME PCLC is important for the OPERATOR distinguish between the following PCLC ,, it it is important for the OPERATOR to to distinguish between the following modes: and places the or OPERATOR the PCLCS places the ME or ME deliberately into into a a nonnon- PCLC mode, OPERATOR ME EQUIPMENT EQUIPMENT ME SYSTEM SYSTEM deliberately PCLC mode, assumes a FALLBACK MODE the and and Subclause 8.2.2.1 – Application specification – assumes a a FALLBACK FALLBACK MODE MODE PCLCS assumes – the the PCLCS – – ME SYSTEM application specification describes The ME EQUIPMENT –orApplication Subclause Subclause 8.2.2.1 8.2.2.1 – Application specification specification that are fundamental to their function The ME EQUIPMENT or PCLCS specification is the foundation for defining the specification describes The ME ME EQUIPMENT EQUIPMENT or or ME ME SYSTEM SYSTEM application application specification describes The that are fundamental to their function The ME EQUIPMENT EQUIPMENT or or that are fundamental to their function The ME specification is for Subclause 8.2.2.2 – State VARIABLES PCLCS specification is the the foundation foundation for defining defining the the PCLCS the important attributes ME SYSTEM application the important important attributes attributes the ME ME SYSTEM SYSTEM application application Carefully specifying– State the traits, qualities, and properties of the important VARIABLES of the Subclause VARIABLES Subclause 8.2.2.2 8.2.2.2 – State VARIABLES PCLCS is an important stage of the design input activity Understanding these characteristics to specify the needed constraints for these VARIABLES Care should permits the MANUFACTURER Carefully VARIABLES of of the the Carefully specifying specifying the the traits, traits, qualities, qualities, and and properties properties of of the the important important VARIABLES be taken to ensure that adequate sampling rates and resolution are used Adequately PCLCS is an important stage of the design input activity Understanding these characteristics PCLCS is an important stage of the design input activity Understanding these characteristics MANUFACTURER duringshould PCLC to better testVARIABLES the PCLC Care developing specification the needed MANUFACTURER specify constraints for permits MANUFACTURER to to permits specify the the needed constraints for these these VARIABLES Care should permits the the this This specification includes characterization of the following items VERIFICATION be taken to ensure that adequate sampling rates and resolution are used Adequately be taken to ensure that adequate sampling rates and resolution are used Adequately developing MANUFACTURER to PCLC during during PCLC PCLC to better better test test the the PCLC developing this this specification specification permits permits the the MANUFACTURER This includes characterization VERIFICATION or REFERENCE VARIABLE – COMMAND VARIABLE This specification specification includes characterization of of the the following following items items VERIFICATION VARIABLE REFERENCE VARIABLE – COMMAND MANUFACTURER should specify the relationship between COMMAND VARIABLE and The COMMAND VARIABLE or or REFERENCE VARIABLE – REFERENCE VARIABLE (see COMMAND TRANSFER ELEMENT ) The MANUFACTURER should specify or REFERENCE VARIABLE is clinically relevant The MANUFACTURER how the COMMAND VARIABLE The MANUFACTURER should should specify specify the the relationship relationship between between COMMAND COMMAND VARIABLE VARIABLE and and The MANUFACTURER COMMAND VARIABLE or REFERENCE VARIABLE The should specify the range of the (see ) The should REFERENCE VARIABLE COMMAND TRANSFER ELEMENT MANUFACTURER REFERENCE VARIABLE (see COMMAND TRANSFER ELEMENT ) The MANUFACTURER should specify specify MANUFACTURER should specify relationship to other VARIABLES of the EQUIPMENT or REFERENCE clinically relevant The how COMMAND VARIABLE VARIABLE or orthe REFERENCE VARIABLE VARIABLE is is input clinically relevant TheMEMANUFACTURER MANUFACTURER how the the COMMAND (e.g a limitation of the COMMAND VARIABLE , which can be set by the OPERATOR ) The ME SYSTEM should COMMAND VARIABLE VARIABLE or or REFERENCE REFERENCE VARIABLE VARIABLE The should specify specify the the range range of of the the COMMAND MANUFACTURER should specify the relationship to other input VARIABLES of the ME EQUIPMENT MANUFACTURER should specify the relationship to other input VARIABLES of the ME EQUIPMENT or or a of VARIABLE ,, which ME SYSTEM VARIABLE orCOMMAND MANIPULATED VARIABLE – (e.g.OUTPUT a limitation limitation of the the COMMAND VARIABLE which can can be be set set by by the the OPERATOR OPERATOR ) ) MECONTROLLER SYSTEM (e.g OUTPUT VARIABLE or VARIABLE – CONTROLLER OUTPUT VARIABLE or MANIPULATED The CONTROLLER OUTPUT VARIABLE or MANIPULATED MANIPULATED VARIABLE VARIABLE should be – CONTROLLER MANUFACTURER should specify limitations of the CONTROLLER OUTPUT VARIABLE or The MANUFACTURER should orspecify the technical meaning the VARIABLE MANIPULATED The CONTROLLER CONTROLLER OUTPUT OUTPUT VARIABLE VARIABLE or MANIPULATED VARIABLE VARIABLE should shouldof be be The or MANIPULATED VARIABLEof OUTPUT VARIABLE MANUFACTURER should specify limitations the CONTROLLER OUTPUT VARIABLE MANUFACTURER should specify limitations of the CONTROLLER OUTPUT VARIABLE or or VARIABLE The MANUFACTURER MANUFACTURER should should specify specify the the technical technical meaning meaning of of the the VARIABLE The or OUTPUT VARIABLE VARIABLE – PHYSIOLOGIC or MANIPULATED MANIPULATED VARIABLE VARIABLE OUTPUT VARIABLE limited The MANIPULATED CONTROLLER limited The limited The MANIPULATED MANIPULATED CONTROLLER CONTROLLER VARIABLE – MANUFACTURER should specify how controlling the PHYSIOLOGIC VARIABLE is clinically The PHYSIOLOGIC VARIABLE – PHYSIOLOGIC relevant The MANUFACTURER should specify the site where the PHYSIOLOGIC VARIABLE is to be should specify expected delays or latency times of is changes in measured The MANUFACTURER The MANUFACTURER should should specify specify how how controlling controlling the the PHYSIOLOGIC PHYSIOLOGIC VARIABLE VARIABLE is clinically clinically The MANUFACTURER MANUFACTURER should specify the site where the PHYSIOLOGIC VARIABLE relevant The is to to be be relevant The MANUFACTURER should specify the site where the PHYSIOLOGIC VARIABLE is MANUFACTURER should specify expected delays or latency times of changes measured The in measured The MANUFACTURER should specify expected delays or latency times of changes in BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 BS EN 60601-1-10:2008 PHYSIOLOGIC VARIABLE the PATIENT - 30 – 28 – after changes in the MANIPULATED VARIABLE , e.g., after a drug is given to – FEEDBACK VARIABLE The MANUFACTURER should specify the sensor characteristics (e.g measuring delay time, measuring range, measuring accuracy) The MANUFACTURER should point out possible USE ERRORS for positioning and using the sensor – Limits of the range of the PATIENT TRANSFER ELEMENT The human variation of the PATIENT TRANSFER ELEMENT can be difficult to characterize but is fundamental to the safe operation of a PCLCS Understanding the limits of variation, both the INTERPATIENT VARIABILITY and the INTRAPATIENT VARIABILITY , of the transfer function that is embodied by the PATIENT TRANSFER ELEMENT , is necessary for the MANUFACTURER to design a safe and effective PCLCS – PCLC modes of operation Beside the control mode and the FALLBACK MODE , the PCLC could have additional operating modes (e.g calibration mode) The MANUFACTURER should specify under which conditions a calibration mode becomes active and what happens to the PCLC when the sensors are undergoing calibration Subclause 8.2.2.3 – F ALLBACK MODE The FALLBACK MODE can be defined by the MANUFACTURER as an open loop mode, which does not present an unacceptable RISK to the PATIENT , whereby the ME EQUIPMENT or ME SYSTEM can continue to be operated in NORMAL USE without utilizing the PCLC This can be, for example, conventional "manual" operation In this example, the MANIPULATED VARIABLE , which is the input VARIABLE to the ACTUATOR , is set to a well-defined value The value needs to be transparent to the OPERATOR It can be calculated from the COMMAND VARIABLE or REFERENCE VARIABLE or it can be an additional input VARIABLE , which can be set by the OPERATOR The MANUFACTURER should specify what happens to the PHYSIOLOGIC VARIABLE if the FALLBACK MODE is active and the MANUFACTURER should specify an adequate OPERATOR response if the FALLBACK MODE is active If it is not possible to define an open loop mode as a FALLBACK MODE , it can also be realized by a backup PCLCS including an independent PCLC In case of failure, the ALARM SYSTEM of the redundant PCLCS should be utilized to notify the OPERATOR Subclause 8.2.2.4 – Specification of operating conditions The specification of operating conditions is intended to ensure safe performance and effectiveness of the PCLC Operating conditions can consist of the adequate selection and application of the following areas: – range of PATIENTS , in terms of e.g weight, age, gender, disease state, pre-existing diseases, pathophysiology, position of the body during treatment, – OPERATOR  TRAINING work load, location (e.g operating operator training,  , work load, location (e.g operatingroom room(OR), (OR),intensive intensive care care – environment (e.g ambient temperature, humidity, EMC, pressure) (PACU)), (ICU), post anesthesia care unit (PACU)), unit Subclause 8.2.2.5 – Limitations of MANIPULATED VARIABLE The MANIPULATED VARIABLE affects the level and rate of change of the PHYSIOLOGIC VARIABLE (e.g dosing rate of a drug, heat delivered by a body temperature controller) To minimize RISKS to the PATIENT , the MANIPULATED VARIABLE frequently needs to have limits on its value, rate of change or integral over a period of time - 31 – 29 – BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 BS EN 60601-1-10:2008 In some cases, it can be sufficient to limit only the MANIPULATED VARIABLE In other cases, the MANIPULATED VARIABLE is limited due to technical reasons (e.g maximal dosing rate of a syringe pump, maximal heating energy) In some cases, it might be necessary to limit the integral of the MANIPULATED VARIABLE (e.g the amount of a drug given within a time frame) Subclause 8.2.2.6 – Responses of the PCLCS It is important that the OPERATOR knows the mode of operation of the PCLC at all times as the can need to intervene in an abnormal situation For an OPERATOR to safely intervene in response to an abnormal situation, the OPERATOR needs to know how the PCLC is operating OPERATOR EXAMPLE A PCLC controls an infusion pump administering a blood pressure altering drug using invasive arterial blood pressure as the PHYSIOLOGIC VARIABLE The PCLC detects a DISTURBANCE VARIABLE (noise in the arterial blood pressure, such as the OPERATOR flushing the measuring system) The PCLC decides to ignore the derivative of the blood pressure temporarily The OPERATOR is required to be notified of the change in mode of operation (loss of derivative implies a mode with slower RESPONSE TIME ) and should be notified of the noise in the PHYSIOLOGIC VARIABLE The ALARM SIGNAL could inform the OPERATOR to “check arterial blood pressure system” Subclause 8.2.2.7 – Range limitation of PHYSIOLOGIC VARIABLE For the PATIENT ’ S safety, it is important that the PCLCS provides means to limit the PHYSIOLOGIC VARIABLE The limits should be capable of being adjusted by the OPERATOR or should be built into the PCLC If the PHYSIOLOGIC VARIABLE exceeds the acceptable range, a well-defined reaction of the PCLC should be provided with the target to bring the PHYSIOLOGIC VARIABLE back within the predefined range If adequate control cannot be re-established, this is likely to lead to FALLBACK MODE To reliably limit the range of the PHYSIOLOGIC VARIABLE or limit the MANIPULATED VARIABLE or CONTROLLER OUTPUT VARIABLE in order to eliminate, control, or reduce RISKS to acceptable levels in SINGLE FAULT CONDITION , the failure of the MEASURING TRANSFER ELEMENT to accurately measure the PHYSIOLOGIC VARIABLE needs to be addressed This is most often accomplished by having two independent means of measuring the PHYSIOLOGIC VARIABLE The first is used to control the ACTUATOR and the second, a redundant one, is used to determine if the operation is appropriate Subclause 8.2.3 – Disturbance management A PCLC can react unfavourably to DISTURBANCE VARIABLES , if means are not provided for compensating for them The means can be different, depending on the DISTURBANCE VARIABLE and the INTENDED USE of the PCLCS EXAMPLE For DISTURBANCE VARIABLES that effect a change in the FEEDBACK VARIABLE , limits can be placed on the absolute value of the FEEDBACK VARIABLE or the rate of change in the FEEDBACK VARIABLE , to prevent the PCLC from over-reacting and making too large a change in the CONTROLLER OUTPUT VARIABLE EXAMPLE VARIABLES The PCLC might be designed to adapt or change modes in reaction to the presence of DISTURBANCE Subclause 8.2.3.2 – Disturbance analysis D ISTURBANCE VARIABLES can perturb a PCLCS It is important to analyze DISTURBANCE VARIABLES since they can have significant impact on PCLC performance The type and magnitude of DISTURBANCE VARIABLES depend on the environment in which the PCLCS is used For example, the performance of a PCLC developed to control arterial blood pressure can be influenced by various DISTURBANCE VARIABLES during use If used following surgery, disturbances could include arterial line flushes, bolus injections of cardiovascular agents, bolus injections of analgesics, etc If used during surgery, additional disturbances include surgical stimuli, PATIENT position changes (e.g., Trendelenburg position), switching the PATIENT on and off the heart-lung bypass pump, etc BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 BS EN 60601-1-10:2008 - 32 – 30 – Each DISTURBANCE VARIABLE can have a different impact on the PCLC performance A flush of the arterial line has a significant but transient impact on the FEEDBACK VARIABLE If unaccounted for, it can lead to a potentially dangerous increase in the CONTROLLER OUTPUT VARIABLE Surgical stimuli and cardiovascular drugs can alter the PATIENT TRANSFER ELEMENT and can cause the PCLC to perform sluggishly or to respond too aggressively Subclause 8.2.4 – P CLC VERIFICATION The committee recognizes that the MANUFACTURERS of most PHYSIOLOGIC CLOSED- LOOP CONTROLLERS are required, by authorities with jurisdiction, to have a design control PROCESS because of the difficulty in ensuring the safe operation of these devices This subclause is intended to ensure that all specifications have been tested and correctly implemented Subclause 8.2.5 – P CLC VALIDATION The committee recognizes that the MANUFACTURERS of most PHYSIOLOGIC CLOSED- LOOP CONTROLLERS are required, by authorities with jurisdiction, to have a design control PROCESS because of the difficulty in ensuring the safety of these devices This subclause is intended to ensure that the requirements for each INTENDED USE or application have been fulfilled Subclause 8.2.5.1 – V ALIDATION plan The committee chose the items listed in the VALIDATION plan because they were considered to be the ones most likely to affect the performance of PHYSIOLOGIC CLOSED - LOOP CONTROLLERS - 33 – 31 – BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 BS EN 60601-1-10:2008 Annex B (informative) Description of dynamic performance of a PCLCS This annex contains example diagrams intended to help the reader understand the relationships between the various PCLCS dynamic performance attributes Since most PCLCS s are non-linear, careful attention should be paid to the amplitude and offset of the step change of the COMMAND VARIABLE when assessing the dynamic performance of a PCLCS because the response of the PHYSIOLOGIC VARIABLE is not linearly related to the amplitude of the step An example of PCLCS dynamic performance with no STEADY - STATE DEVIATION is shown in Figure B.1 It is an illustration of how the PHYSIOLOGIC VARIABLE (y going from y to y ∞ ) might change following a step increase in the COMMAND VARIABLE (c) In this example, since there is no STEADY - STATE DEVIATION, the RELATIVE OVERSHOOT (y ro ) equals the COMMAND OVERSHOOT (y co ) BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 - 34 – 32 – BS EN 60601-1-10:2008 y c yro and yco y∞ ±5% 95 % 90 % y0 y t Tr Tst IEC 2069/07 Legend c t Tr T st y y0 y∞ y ro y co COMMAND VARIABLE time RESPONSE TIME SETTLING TIME PHYSIOLOGIC VARIABLE initial value of the PHYSIOLOGIC VARIABLE average steady-state value of the PHYSIOLOGIC VARIABLE RELATIVE OVERSHOOT COMMAND OVERSHOOT Figure B.1 – Example of PCLCS dynamic performance with no STEADY - STATE DEVIATION An example of PCLCS dynamic performance with STEADY - STATE DEVIATION is shown in Figure B.2 It is an illustration of how the PHYSIOLOGIC VARIABLE (y going from y to y ∞ ) might change following a step increase in the COMMAND VARIABLE (c) In this example since there is STEADY - STATE DEVIATION (y sd ), the RELATIVE OVERSHOOT (y ro ) is different than the COMMAND OVERSHOOT (y co ) - 35 – 33 – y BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 BS EN 60601-1-10:2008 c yro yco y∞ ysd 95 % 90 % y y0 t Tr Tst IEC 2070/07 Key c t Tr T st y y0 y∞ y ro y co y sd COMMAND VARIABLE time RESPONSE TIME SETTLING TIME PHYSIOLOGIC VARIABLE initial value of the PHYSIOLOGIC VARIABLE average steady-state value of the PHYSIOLOGIC VARIABLE RELATIVE OVERSHOOT COMMAND OVERSHOOT STEADY - STATE DEVIATION Figure B.2 – Example of PCLCS dynamic performance with STEADY - STATE DEVIATION An example of PCLCS dynamic performance with a linear increase in the COMMAND VARIABLE (c) is shown in Figure B.3 It is an illustration of how the PHYSIOLOGIC VARIABLE (y) might change This example shows the TRACKING ERROR (E tr ) BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 BS EN 60601-1-10:2008 - 36 – 34 – y c Etr y t IEC 2071/07 Key c E tr t y COMMAND VARIABLE TRACKING ERROR time PHYSIOLOGIC VARIABLE Figure B.3 – Example of PCLCS dynamic performance transient COMMAND VARIABLE - 37 – 35 – BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 BS EN 60601-1-10:2008 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT ME SYSTEMS C.1 and ACCOMPANYING DOCUMENTS , instructions for use The requirements for information to be included in the instructions for use are found in Subclause 7.9.2 and in Table C.5 of the general standard Additional requirements for information to be included in the instructions for use are found in the subclauses listed in Table C.2 Table C.2 – ACCOMPANYING DOCUMENTS , instructions for use Description of requirement Details necessary for mental model of operation of a PCLCS Clause/ Subclause 5.1 Means to monitor PHYSIOLOGIC VARIABLE 8.2.2.7 Measures or means to limit the MANIPULATED VARIABLE 8.2.2.5 Measures or means to limit the changes in MANIPULATED VARIABLE in response to DISTURBANCE 8.2.3.3 VARIABLES PCLCS VARIABLE logging 6.3 Range of limitation of the CONTROLLER OUTPUT VARIABLE or MANIPULATED VARIABLE 8.2.2.7 Summary of application specification 8.2.2.1 Summary of FALLBACK MODES 8.2.2.3 C.2 ACCOMPANYING DOCUMENTS , technical description The requirements for general information to be included in the technical description are found in subclause 7.9.3 and in Table C.6 of the general standard Additional requirements for general information to be included in the technical description are found in the subclauses listed in Table C.3 Table C.3 – ACCOMPANYING DOCUMENTS , technical description Description of requirement Details necessary for the safe use of a DISTRIBUTED PCLCS Clause/ Subclause 6.4 Summary of the PCLC modes of operation and specification of PCLCS responses 8.2.2.6 Means to check responses of the PCLCS 8.2.2.6 BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 BS EN 60601-1-10:2008 - 38 – 36 – Bibliography [1] ISO/IEC Guide 51:1999, Safety aspects – Guidelines for their inclusion in standards [2] IEC Guide 109:2003, Environmental aspects – Inclusion in electrotechnical product standards [3] IEC 60050-351:2006, International Electrotechnical Vocabulary – Part 351: Control technology [4] ISO 9000:2005, Quality management systems – Fundamentals and vocabulary NOTE [5] NOTE [6] NOTE [7] NOTE Harmonized as EN ISO 9000:2005 (not modified) ISO 14001:2004, Environmental management systems – Requirements with guidance for use Harmonized as EN ISO 14001:2004 (not modified) ISO 14021:1999, Environmental labels and declarations – Self-declared environmental claims (Type II environmental labelling) Harmonized as EN ISO 14021:2001 (not modified) ISO 14040:2006, Environmental management – Life cycle assessment – Principles and framework Harmonized as EN ISO 14040:2006 (not modified) [8] ISO/TR 14062:2002, Environmental management – Integrating environmental aspects into product design and development [9] COSGROVE, DM., PETRE, JH et al Automated control of postoperative hypertension: a prospective, randomized multicentrer study Ann Thorac Surg 1989: 47pp.678-83 [10] IRSIGLER, K et al Use of glucose-controlled insulin infusion system for improvement of subcutaneous insulin regime Horm Metab Res, suppl 8, 1979, pp.134-140 [11] MOROZOFF, PE, EVANS, RW Closed-loop control of SaO in the neonate Biomedical Instrumentation and Technology, Apr 92 pp 117-123 [12] OZYOL, MB et al Post-operative blood glucose regulation of pancreatectomized patients using the artificial b-cell Chir , 1979, 50: pp.227-232 [13] REVES, JG., SHEPPARD LC Therapeutic uses of sodium nitroprusside and an automated method of administration International Anesthesiology Clinics, 1978, 16:2, pp.51-87 - 39 – 37 – BS EN 60601-1-10:2008+A1:2015 IEC 60601-1-10:2007+A1:2013 BS EN 60601-1-10:2008 Index of defined terms used in this collateral standard ACCOMPANYING DOCUMENT ACTUATOR IEC 60601-1: 2005, 3.4 (A) 3.1 60601-1-8:2006, ALARM CONDITION IEC  IEC 60601-1-8:2006+A1:2012, ALARM SIGNAL 3.1  IEC 60601-1-8:2006, 3.9 ALARM SYSTEM IEC 60601-1-8:2006, 3.11 BASIC SAFETY IEC 60601-1: 2005, 3.10 COMMAND OVERSHOOT 3.2 COMMAND TRANSFER ELEMENT COMMAND VARIABLE (C) 3.3 (c) 3.4 COMPARING ELEMENT (D) 3.5 CONTROL TRANSFER ELEMENT (E) 3.6 CONTROLLER OUTPUT VARIABLE 3.8 DISTRIBUTED PCLCS DISTURBANCE VARIABLE ERROR VARIABLE (x) 3.7 (v) 3.9 (e) 3.10 ESSENTIAL PERFORMANCE IEC 60601-1: 2005, 3.27   IEC 60601-1:2005+A1:2012, FALLBACK MODE 3.11 FEEDBACK VARIABLE HAZARD (f) 3.12  IEC 60601-1:2005+A1:2012, IEC 60601-1:2005, 3.39  INFORMATION SIGNAL INTENDED USE IEC 60601-1-8:2006, 3.23  IEC 60601-1:2005+A1:2012, IEC 60601-1:2005, 3.44  INTERNAL ELECTRICAL POWER SOURCE IEC 60601-1:2005, 3.45 INTERPATIENT VARIABILITY 3.13 INTRAPATIENT VARIABILITY 3.14 MANIPULATED VARIABLE (m) 3.15  IEC 60601-1:2005+A1:2012, IEC 60601-1:2005, MANUFACTURER ME EQUIPMENT ME SYSTEM IEC 60601-1:2005, 3.63 IEC 60601-1:2005, 3.64 MEASURING TRANSFER ELEMENT (F) 3.16 NORMAL CONDITION IEC 60601-1:2005, 3.70  IEC 60601-1:2005+A1:2012, NORMAL USE IEC 60601-1:2005, OBJECTIVE EVIDENCE OPERATOR 3.55  3.71   IEC 60601-1:2005+A1:2012, IEC 60601-1:2005, 3.72  IEC 60601-1:2005, 3.73 OPERATOR PROFILE .IEC 60601-1-6:2006, 3.5  IEC 60601-1:2005+A1:2012, PATIENT IEC 60601-1:2005, PATIENT ENVIRONMENT IEC PATIENT DISTURBANCE VARIABLE PATIENT TRANSFER ELEMENT 3.76  60601-1:2005, 3.79 (v p ) 3.17 (P) 3.18 PHYSIOLOGIC CLOSED - LOOP CONTROL SYSTEM ( PCLCS ) 3.19 PHYSIOLOGIC CLOSED - LOOP CONTROLLER ( PCLC ) PHYSIOLOGIC VARIABLE PROCESS 3.20 (y) 3.21  IEC 60601-1:2005+A1:2012, IEC 60601-1:2005, 3.89 

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