BS EN ISO 80601-2-12:2020
$215.11
Medical electrical equipment – Particular requirements for basic safety and essential performance of critical care ventilators
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 154 |
Clause 1 of the general standard applies, except as follows:
NOTE The general standard is IEC 60601-1:2005+AMD1:2012.
201.1.1 * Scope
Replacement:
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:
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intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.
NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.
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intended to be operated by a healthcare professional operator; and
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intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
A critical care ventilator is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
NOTE 4 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.
NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation.
NOTE 6 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining.
This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.
This document does not specify the requirements for:
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ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[2];
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ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84[3], the future replacement for ISO 10651-3[4];
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ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72:2015[5];
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ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018[6] and ISO 80601-2-80:2018[7]1;
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obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70[9];
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continuous positive airway pressure (CPAP) ME equipment;
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high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[63];
NOTE 7 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes.
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oxygen therapy constant flow ME equipment; and
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cuirass or “iron-lung” ventilation equipment.
201.1.2 Object
Replacement:
The object of this document is to establish basic safety and essential performance requirements for a ventilator and its accessories.
Accessories are included because the combination of the ventilator and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of a ventilator.
NOTE 1 This document has been prepared to address the relevant essential principles ofsafety and performance of ISO 16142-1:2016 as indicated in Annex CC.
NOTE 2 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 as indicated in Annex DD.
201.1.3 Collateral standards
Amendment (add after existing text):
This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and in 201.2 of this document.
IEC 60601-1-2, IEC 60601-1-6 and IEC 60601-1-8 apply as modified in Clauses 202, 206 and 208 respectively. IEC 60601-1-3[12], IEC 60601-1-9[13], IEC 60601-1-11 and IEC 60601-1-12 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard, including the collateral standards, as appropriate for the particular ME equipment under consideration, and may add other basic safety or essential performance requirements.
A requirement of a particular standard takes priority over IEC 60601-1:2005 or the collateral standards.
For brevity, IEC 60601-1:2005+AMD1:2012 is referred to in this particular document as the general standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this document corresponds to those of the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits of the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 208.4 in this document addresses the content of Clause 4 of the IEC 60601-1-8 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:
“Replacement” means that the clause or subclause of IEC 60601-1:2005+AMD1:2012 or the applicable collateral standard is replaced completely by the text of this document.
“Addition” means that the text of this document is additional to the requirements of IEC 60601-1:2005+AMD1:2012 or the applicable collateral standard.
“Amendment” means that the clause or subclause of IEC 60601-1:2005+AMD1:2012 or the applicable collateral standard is amended as indicated by the text of this document.
Subclauses, figures or tables that are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3[12], etc.
The term “this document” is used to make reference to the general standard, any applicable collateral standards and this particular document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause of IEC 60601-1:2005+AMD1:2012 or the applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601-1:2005+AMD1:2012 or the applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular document.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 5 | European foreword Endorsement notice |
| 15 | 201. 1 Scope, object and related standards 201. 1.1 * Scope |
| 16 | 201. 1.2 Object |
| 17 | 201. 1.3 Collateral standards 201. 1.4 Particular standards |
| 18 | 201. 2 Normative references |
| 21 | 201. 3 Terms and definitions |
| 23 | 201. 4 General requirements 201. 4.3 Essential performance 201. 4.3.101 * Additional requirements for essential performance 201. 4.4 Additional requirements for expected service life |
| 24 | 201. 4.6 * ME equipment or ME system parts that contact the patient 201. 4.11.101 * Additional requirements for pressurized gas input 201. 4.11.101.1 Overpressure requirement 201. 4.11.101.2 Compatibility requirement |
| 25 | 201. 5 General requirements for testing of ME equipment 201. 5.101 Additional requirements for general requirements for testing of ME equipment 201. 5.101.1 Ventilator test conditions 201. 5.101.2 * Gas flowrate and leakage specifications 201. 5.101.3 * Ventilator testing errors |
| 26 | 201. 6 Classification of ME equipment and ME systems 201. 7 ME equipment identification, marking and documents 201. 7.2.3 * Consult accompanying documents 201. 7.2.4.101 Additional requirements for accessories 201. 7.2.13.101 Additional requirements for physiological effects 201. 7.2.17.101 Additional requirements for protective packaging |
| 27 | 201. 7.2.18 External gas source 201. 7.2.101 * Additional requirements for marking on the outside of ME equipment or ME equipment parts |
| 28 | 201. 7.4.3 * Units of measurement 201. 7.9.1 Additional general requirements 201. 7.9.2.1.101 Additional general requirements |
| 29 | 201. 7.9.2.2.101 * Additional requirements for warnings and safety notices |
| 30 | 201. 7.9.2.8.101 * Additional requirements for start-up procedure 201. 7.9.2.9.101 * Additional requirements for operating instructions |
| 31 | 201. 7.9.2.12 Cleaning, disinfection, and sterilization 201. 7.9.2.14.101 * Additional requirements for accessories, supplementary equipment, used material |
| 32 | 201. 7.9.2.16.101 * Additional requirements for reference to the technical description 201. 7.9.3.1.101 * Additional general requirements 201. 7.9.3.101 Additional requirements for the technical description |
| 33 | 201. 8 Protection against electrical hazards from ME equipment 201. 9 Protection against mechanical hazards of ME equipment and ME systems 201. 9.6.2.1.101 * Additional requirements for audible acoustic energy |
| 34 | 201. 9.101 * Additional requirements for suction procedures |
| 37 | 201. 10 Protection against unwanted and excessive radiation hazards 201. 11 Protection against excessive temperatures and other hazards 201. 11.1.2.2 * Applied parts not intended to supply heat to a patient 201. 11.6.5.101 * Additional requirements for ingress of water or particulate matter into ME equipment or ME system |
| 38 | 201. 11.6.6 * Cleaning and disinfection of ME equipment or ME system 201. 11.6.7 Sterilization of ME equipment or ME system 201. 11.7 Biocompatibility of ME equipment and ME systems |
| 39 | 201. 11.8.101 * Additional requirements for interruption of the power supply/supply mains to ME equipment |
| 41 | 201. 12 Accuracy of controls and instruments and protection against hazardous outputs 201. 12.1 * Accuracy of controls and instruments 201. 12.1.101 * Volume-control inflation-type |
| 45 | 201. 12.1.102 * Pressure-control inflation-type |
| 48 | 201. 12.1.103 Other inflation-types |
| 49 | 201. 12.1.104 * Inspiratory volume monitoring 201. 12.1.105 * Response of the ventilator to an increase in set O2 concentration |
| 51 | 201. 12.4 Protection against hazardous output 201. 12.4.101 Oxygen monitor |
| 52 | 201. 12.4.102 * Measurement of airway pressure |
| 53 | 201. 12.4.103 * Measurement of expired volume and low volume alarm conditions 201. 12.4.103.1 Ventilators intended to provide a tidal volume >50 ml |
| 54 | 201. 12.4.103.2 Ventilators intended to provide a tidal volume ≤50 ml |
| 55 | 201. 12.4.104 * Expiratory end-tidal CO2 monitoring equipment |
| 56 | 201. 12.4.105 * Maximum limited pressure protection device 201. 12.4.106 * High airway pressure alarm condition and protection device |
| 57 | 201. 12.4.107 PEEP alarm conditions |
| 58 | 201. 12.4.108 * Obstruction alarm condition |
| 59 | 201. 12.4.109 * Disconnection alarm condition 201. 12.4.110 Protection against inadvertent setting of high airway pressure 201. 12.101 * Protection against accidental or unintentional adjustments |
| 60 | 201. 13 Hazardous situations and fault conditions for ME equipment 201. 13.2.101 * Additional specific single fault conditions 201. 13.2.102 * Failure of one gas supply to a ventilator |
| 61 | 201. 13.2.103 * Independence of ventilation control function and related risk control measures 201. 13.2.104 * Failure of functional connection to a ventilator control or monitoring means 201. 14 Programmable electrical medical systems (PEMS) |
| 62 | 201. 14.101 Software life cycle 201. 15 Construction of ME equipment 201. 15.3.5.101 Additional requirements for rough handling 201. 15.3.5.101.1 * Shock and vibration (robustness) |
| 63 | 201. 15.3.5.101.2 * Shock and vibration for a transit-operable ventilator during operation |
| 65 | 201. 15.4.1 Construction of connectors 201. 15.101 Mode of operation 201. 15.102 Delivered oxygen concentration 201. 15.103 Accessory self-check |
| 66 | 201. 16 ME systems 201. 16.1.101 Additional general requirements for ME systems 201. 16.2.101 * Additional general requirements for accompanying documents of an ME system 201. 17 Electromagnetic compatibility of ME equipment and ME systems 201. 101 Gas connections 201. 101.1 * Protection against reverse gas leakage |
| 67 | 201. 101.2 Connection to a high-pressure input port 201. 101.2.1 Connector 201. 101.2.2 * Filter 201. 101.3 VBS connectors 201. 101.3.1 * General 201. 101.3.2 Other named ports 201. 101.3.2.1 Patient-connection port |
| 68 | 201. 101.3.2.2 Gas output port and gas return port 201. 101.3.2.3 Emergency intake port 201. 101.3.2.4 Flow-direction-sensitive components 201. 101.3.2.5 * Accessory port |
| 69 | 201. 101.3.2.6 Gas exhaust port 201. 101.3.2.7 Temperature sensor port 201. 102 Requirements for the VBS and accessories 201. 102.1 * General 201. 102.2 Labelling 201. 102.3 Breathing tubes |
| 70 | 201. 102.4 * Water vapour management 201. 102.4.1 Humidification system 201. 102.4.2 Heat and moisture exchanger (HME) 201. 102.6 Breathing system filters 201. 102.7 Ventilator breathing systems 201. 102.7.1 * Leakage from complete VBS |
| 71 | 201. 102.7.2 * Non-invasive ventilation 201. 103 * Spontaneous breathing during loss of power supply 201. 104 * Indication of duration of operation |
| 72 | 201. 105 Functional connection 201. 105.1 General 201. 105.2 * Connection to an electronic health record 201. 105.3 * Connection to a distributed alarm system 201. 105.4 Connection for remote control 201. 106 Display loops 201. 106.1 Pressure-volume loops |
| 73 | 201. 106.2 Flow-volume loops 201. 107 * Timed ventilatory pause 201. 107.1 Expiratory pause |
| 74 | 201. 107.2 Inspiratory pause |
| 75 | 202 Electromagnetic disturbances — Requirements and tests 202.4.3.1 * Compliance criteria 202.5.2.2.1 Requirements applicable to all ME equipment and ME systems 202.8.1.101 * Additional general requirements |
| 76 | 206 Usability 206.101 Primary operating functions |
| 77 | 206.102 * Training |
| 78 | 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 208.6.3.2.2.2.101 Additional requirements for 1 m (operator’s position) visual alarm signals and information signals 208.6.8.3.101 Additional requirements for global indefinite alarm signal inactivation states 208.6.8.4.101 * Additional requirements for termination of alarm signal inactivation 208.6.12.101 * Additional requirements for alarm system logging |
| 80 | Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems 201.C.101 Marking on the outside of ME equipment, ME systems or their parts |
| 81 | 201.C.102 Accompanying documents, general 201.C.103 Accompanying documents, instructions for use |
| 84 | 201.C.104 Accompanying documents, technical description |
| 85 | Annex D (informative) Symbols on marking |
| 89 | Annex AA (informative) Particular guidance and rationale AA.1 General guidance AA.2 Rationale for particular clauses and subclauses |
| 128 | Annex BB (informative) Data interfaces BB.1 Background and purpose |
| 129 | BB.2 Data definition |
| 137 | Annex CC (informative) Reference to the essential principles |
| 140 | Annex DD (informative) Reference to the general safety and performance requirements |
| 143 | Annex EE (informative) Terminology — Alphabetized index of defined terms |
| 148 | Bibliography |
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