Medical Electrical Equipment-Part 2-84:ParticularRequirementsForTheBasicSafetyAndEssentialPerformanceOfVentilatorsForTheEmergencyMedicalServicesEnvironment
TableOfContents
ISO 80601-2-84:2020.essa pe as ois a sanba en e aa eaa eperformance of ventilators for the emergency medical services environment.. .1Foreword. Introduction. .6 .5201.1 Scope object and related standards. 201.1.1 * Scope.... .6201.1.2 Object.. .7201.1.3 Collateral standards. .7201.2 Normative references. 201.1.4 Particular standards.201.3 Terms and definitions. ...8 10201.4 General requirements. 201.4.3 Essential performance. .10 10201.4.4 Additional requirements for expected service life. ..10201.4.6 * ME equipment or ME system parts that contact the patient. ..10201.5 General requirements for testing of ME equipment.. 201.5.101 * Additional requirements for general requirements for testing of ME equipment. ..12 .12201.6 Classification of ME equipment and ME systems. ..2201.7 ME equipment identification marking and documents.. ..12201.7.2.3 *Consult acpanying documents. 201.7.2.18 External gas source.. ...13201.7.2.101 * Additional requirements for marking on the outside of ME equipment or ME equipmentparts.... 201.7.4.2 * Control devices. .13 .14201.7.4.3 * Units of measurement... .14201.7.9.1 Additional general requirements. 201.7.4.101 Labelling of units of measurement.. ...14 ..14201.8 Protection against electrical hazards from ME equipment.. ..17201.9 Protection against mechanical hazards of ME equipment and ME systems. .17201.9.4.3.101 * Additional requirements for instability from unwanted lateral movement. 201.9.4.4 Grips and other handling devices... ...18 .18201.10 Protection against unwanted and excessive radiation hazards. .19201.11 Protection against excessive temperatures and other hazards.. .uged e on eauddnsoppuau ou sredydd. ..19 .19201.11.6.6 * Cleaning and disinfection of ME equjpment or ME system.... ..20201.11.6.7 Sterilization of ME equipment or ME system.. 201.11.7 Biopatibility of ME equipment and ME systems. ...20 .20201.12 Accuracy of controls and instruments and protection against hazardous outputs. ..21201.12.1.101 * Volume-control inffation-type.... ..21201.12.1.102 * Pressure-controlled inffation-type.. 201.12.1.103 Other inffation-type.... ..6 ..24201.12.1.104 Inspiratory volume monitoring equipment.. ..26201.12.4 Protection against hazardous output... ...26201.13 Hazardous situations and fault conditions for ME equipment. 201.13.2.101 Additional specific single fault conditions.. ..30201.13.102 Failure of one gas supply to an EMS ventilato... ..30201.13.103 * Independence of ventilation control function and related risk controf measures. ..30
201.14 Programmable electrical medical systems (PEMS). .30201.14.101 Software life cycle.. .31201.15 Construction of ME equipment.. .31201.15.4.1 Construction of connectors... .31 31201.15.101 Mode of operation. 31201.15.102 * Delivered oxygen concentration.. 201.15.103 Accessory self-check. ..32 31201.16 ME systems.. 32201.16.3.101 Additional requirements for power supply. 201.16.1.101 Additional general requirements for ME systems.. .32201.17 Electromagnetic patibility of ME equipment and ME systems.. ..32 .32201.101 Gas connections.. 32201.101.2 Connection to a high-pressure input porf. .32 .33201.101.3 VBS connectors..201.102 Requirements for the VBS and accessories... ...34201.102.2 Labelling.... 201.102.1 * General. 34 34201.102.3 Breathing tubes.... 34201.102.4 * Water vapour managemen.. 201.102.5 Breathing systerm fiters.. 35 35201.102.6 * Leakage from plete VBS. ...35201.103 Spontaneous breathing during loss of power supply. .35201.104 * Indication of duration of operation... 201.105 Functionaf connection... 36201.105.1 General. 98201.105.3 * Connection to a distributed alarm system.. 201.105.2 * Connection to an electronic health record. ..36 .36201.106 Display loops... 36201.106.2 Flow-volume loops.. 201.106.1 Pressure-volume loops.... ...36 ..36201.107 * Timed ventilatory pause.. 37201.107.1 Expiratory pause... 37201.107.2 Inspiratory pause.... ..7202 Electromagnetic disturbances - Requirements and tests. 202.4.3.1 * Compliance criteria.. ..37 37202.8.1.101 * Additional general requirements. ...38206 Usability. 38206.101 Primary operating functions.. 206.102 Bue ...40 .38208 General requirements tests and guidance for alarm systems in medical electrical equipment andmedical electrical systems. 40208.6.3.2.2.1 * 4 m (distant) visual alarm signa/s. 208.6.8.3.101 Aditional requirements for global indefinite alarm signal inactivation states. ...0 40208.6.12.101 * Additional requirements for alarm system logging. iseosb .40212 Requirements for medical electrical equipment and medical electrical systems intended for use in the ...40emergency medical services environment. 41212.4.2.2.1 Continuous operating conditions. 41
41212.8.2Additional requirements forinterruptionof the power supply to ME equjpment and ME system.41212.8.3 Additional requirements for internal electrical power source for ME equipment. .41Guide to marking and labeling requirements for ME equipment and ME systems. Annex C... 42 42201.C.1 Marking on the outside of ME equipment ME systems or their parts. 42201.C.2 Acpanying documents general.. 201.C.3 Acpanying documents instructions for use. 43 43201.C.4 Acpanying documents technical description. 46Symbols on marking.. Annex D. 46 46Annex AA. 48Particular guidance and rationale. AA.1 General guidance. 48 48AA.2 Rationale for particular clauses and subclauses.. 48Data interfaces. Annex BB. 73 73BB.1 Background and purpose. BB.2 Data definition. 73Annex CC. 74 79Reference to the essential principles.. 79Terminology- Annex DD.. Alphabetized index of defined terms. 81 81Bibliography.- 88
Foreword
yno no pae Aijeou s spepuis euogau buyedad jo xiom a (sapoq jaqwa osi) saipoISO technical mittees. Each member body interested in a subject for which a technical mittee has been established has the right to be represented on that mittee. International organizations
govermmental and non-governmental in liaison with ISO also take part in the work. ISO collaborates closely
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives Part 1. In particular the different approval criteria needed for the diferent types ofISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives Part 2 (see
Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent josll i auo opue uonpou a u aq sunp a jo adoaap a unp p spatent declarations received (see
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For an explanation of the voluntary nature of standards the meaning of ISO specific terms and expressionsrelated to conformity assessment as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see Submittee SC 3 Respiratory devices and related equipment used for patient care and Technical Committee IEC/TC 62 Electrica/ equipment in medical practice Submittee 62D Electromedical equipment.
changes pared to the previous edition are as follows:
- extension of the scope to include the EMS ventilator and its accessories where thecharacteristics of those accessories can affect the basic safety or essential performance of the ventilator for the emergency medical services environment and thus not only the ventilator for theemergency medical services ervironment itself;environment and its accessories; identification of essential performarce for ventilator for the emergency medical servicesmodification of the tests for environmental conditions (via IEC 60601-1-12): modification of the tests for electromagnetic disturbances (via IEC 60601-1-2); modification of the tests for alarm conditions (via IEC 60601-1-8); addition of the following:- tests for ventilation performance; - test for instability from unwanted lateral movement;-test for audible acoustic energy;- tests for mechanical strength (via IEC 60601-1-12); - tests for environmental conditions (via IEC 60601-1-12);-tests for alarm conditions (via IEC 60601-1-8):- tests for electromagnetic disturbances (via IEC 60601-1-2); - inclusion of the usability engineering process (via IEC 60601-1-6);- new symbols;- requirements for ventilator for the emergency medical services environment as a ponent of an ME system;- tests for enclosure integrity (water ingress via IEC 60601-1-12);:- tests for cleaning and disinfection;
