Clause 1 of the general standard applies, except as follows:<\/p>\n
\nNOTE The general standard is IEC 60601-1:2005+AMD1:2012.<\/p>\n<\/blockquote>\n
201.1.1<\/b> * Scope<\/p>\n
Replacement:<\/i><\/p>\n
This document applies to the basic safety<\/i> and essential performance<\/i> of a ventilator<\/i> in combination with its accessories<\/i>, hereafter referred to as ME equipment:<\/i><\/p>\n
\n
- \n
intended for use in an environment that provides specialized care for patients<\/i> whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;<\/i><\/p>\n
\nNOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators<\/i> for this environment are considered life-sustaining.<\/p>\n<\/blockquote>\n
\nNOTE 2 For the purposes of this document, such a ventilator<\/i> can provide transport within a professional healthcare facility<\/i> (i.e. be a transit-operable ventilator<\/i>).<\/p>\n<\/blockquote>\n
\nNOTE 3 A critical care ventilator<\/i> intended for use in transport within a professional healthcare facility<\/i> is not considered as an emergency medical services environment ventilator<\/i>.<\/p>\n<\/blockquote>\n<\/li>\n
- \n
intended to be operated by a healthcare professional operator<\/i>; and<\/p>\n<\/li>\n
- \n
intended for those patients<\/i> who need differing levels of support from artificial ventilation including for ventilator-dependent patients<\/i>.<\/p>\n<\/li>\n<\/ul>\n
A critical care ventilator<\/i> is not considered to utilize a physiologic closed-loop-control system<\/i> unless it uses a physiological patient<\/i> variable to adjust the ventilation therapy settings.<\/p>\n
This document is also applicable to those accessories<\/i> intended by their manufacturer<\/i> to be connected to a ventilator breathing system<\/i>, or to a ventilator<\/i>, where the characteristics of those accessories<\/i> can affect the basic safety<\/i> or essential performance<\/i> of the ventilator<\/i>.<\/p>\n
\nNOTE 4 If a clause or subclause is specifically intended to be applicable to ME equipment<\/i> only, or to ME systems<\/i> 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<\/i> and to ME systems<\/i>, as relevant.<\/p>\n<\/blockquote>\n
Hazards<\/i> inherent in the intended physiological function of ME equipment<\/i> or ME systems<\/i> 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.<\/p>\n
\nNOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.<\/p>\n<\/blockquote>\n
This document is not applicable to ME equipment<\/i> or an ME system<\/i> operating in a ventilator-operational mode<\/i> solely intended for patients<\/i> who are not dependent on artificial ventilation.<\/p>\n
\nNOTE 6 A critical care ventilator<\/i>, when operating in such a ventilator-operational mode<\/i>, is not considered life-sustaining.<\/i><\/p>\n<\/blockquote>\n
This document is not applicable to ME equipment<\/i> that is intended solely to augment the ventilation of spontaneously breathing patients<\/i> within a professional healthcare facility<\/i>.<\/p>\n
This document does not specify the requirements for:<\/p>\n
\n
- \n
ventilators<\/i> or accessories<\/i> intended for anaesthetic applications, which are given in ISO 80601-2-13[2]<\/sup>;<\/p>\n<\/li>\n
- \n
ventilators<\/i> or accessories<\/i> intended for the emergency medical services environment<\/i>, which are given in ISO 80601-2-84[3]<\/sup>, the future replacement for ISO 10651-3[4]<\/sup>;<\/p>\n<\/li>\n
- \n
ventilators<\/i> or accessories<\/i> intended for ventilator-dependent patients<\/i> in the home healthcare environment,<\/i> which are given in ISO 80601-2-72:2015[5]<\/sup>;<\/p>\n<\/li>\n
- \n
ventilators<\/i> or accessories<\/i> intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018[6]<\/sup> and ISO 80601-2-80:2018[7]<\/sup>1<\/sup>;<\/p>\n<\/li>\n
- \n
obstructive sleep apnoea therapy ME equipment<\/i>, which are given in ISO 80601-2-70[9]<\/sup>;<\/p>\n<\/li>\n
- \n
continuous positive airway pressure<\/i> (CPAP<\/i>) ME equipment;<\/i><\/p>\n<\/li>\n
- \n
high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[63]<\/sup>;<\/p>\n
\nNOTE 7 A critical care ventilator<\/i> can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes<\/i>.<\/p>\n<\/blockquote>\n<\/li>\n
- \n
oxygen therapy constant flow ME equipment<\/i>; and<\/p>\n<\/li>\n
- \n
cuirass or \u201ciron-lung\u201d ventilation equipment.<\/p>\n<\/li>\n<\/ul>\n
201.1.2<\/b> Object<\/p>\n
Replacement:<\/i><\/p>\n
The object of this document is to establish basic safety<\/i> and essential performance<\/i> requirements for a ventilator<\/i> and its accessories<\/i>.<\/p>\n
Accessories<\/i> are included because the combination of the ventilator<\/i> and the accessories<\/i> needs to be adequately safe. Accessories<\/i> can have a significant impact on the basic safety<\/i> or essential performance<\/i> of a ventilator<\/i>.<\/p>\n
\nNOTE 1 This document has been prepared to address the relevant essential principles ofsafety and performance<\/i> of ISO 16142-1:2016 as indicated in Annex CC.<\/p>\n<\/blockquote>\n
\nNOTE 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.<\/p>\n<\/blockquote>\n
201.1.3<\/b> Collateral standards<\/p>\n
Amendment (add after existing text):<\/i><\/p>\n
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.<\/p>\n
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]<\/sup>, IEC 60601-1-9[13]<\/sup>, 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.<\/p>\n
201.1.4<\/b> Particular standards<\/p>\n
Replacement:<\/i><\/p>\n
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<\/i> under consideration, and may add other basic safety<\/i> or essential performance<\/i> requirements.<\/p>\n
A requirement of a particular standard takes priority over IEC 60601-1:2005 or the collateral standards.<\/p>\n
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.<\/p>\n
The numbering of clauses and subclauses of this document corresponds to those of the general standard with the prefix \u201c201\u201d (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix \u201c2xx\u201d 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:<\/p>\n
\u201cReplacement\u201d 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.<\/p>\n
\u201cAddition\u201d means that the text of this document is additional to the requirements of IEC 60601-1:2005+AMD1:2012 or the applicable collateral standard.<\/p>\n
\u201cAmendment\u201d 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.<\/p>\n
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),<\/i> bb),<\/i> etc.<\/p>\n
Subclauses or figures that are additional to those of a collateral standard are numbered starting from 20x, where \u201cx\u201d is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3[12]<\/sup>, etc.<\/p>\n
The term \u201cthis document\u201d is used to make reference to the general standard, any applicable collateral standards and this particular document taken together.<\/p>\n
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.<\/p>\n
PDF Catalog<\/h4>\n
\n
\n PDF Pages<\/th>\n PDF Title<\/th>\n<\/tr>\n \n 2<\/td>\n undefined <\/td>\n<\/tr>\n \n 5<\/td>\n European foreword
Endorsement notice <\/td>\n<\/tr>\n\n 15<\/td>\n 201. 1 Scope, object and related standards
201. 1.1 * Scope <\/td>\n<\/tr>\n\n 16<\/td>\n 201. 1.2 Object <\/td>\n<\/tr>\n \n 17<\/td>\n 201. 1.3 Collateral standards
201. 1.4 Particular standards <\/td>\n<\/tr>\n\n 18<\/td>\n 201. 2 Normative references <\/td>\n<\/tr>\n \n 21<\/td>\n 201. 3 Terms and definitions <\/td>\n<\/tr>\n \n 23<\/td>\n 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 <\/td>\n<\/tr>\n\n 24<\/td>\n 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 <\/td>\n<\/tr>\n\n 25<\/td>\n 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 <\/td>\n<\/tr>\n\n 26<\/td>\n 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 <\/td>\n<\/tr>\n\n 27<\/td>\n 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 <\/td>\n<\/tr>\n\n 28<\/td>\n 201. 7.4.3 * Units of measurement
201. 7.9.1 Additional general requirements
201. 7.9.2.1.101 Additional general requirements <\/td>\n<\/tr>\n\n 29<\/td>\n 201. 7.9.2.2.101 * Additional requirements for warnings and safety notices <\/td>\n<\/tr>\n \n 30<\/td>\n 201. 7.9.2.8.101 * Additional requirements for start-up procedure
201. 7.9.2.9.101 * Additional requirements for operating instructions <\/td>\n<\/tr>\n\n 31<\/td>\n 201. 7.9.2.12 Cleaning, disinfection, and sterilization
201. 7.9.2.14.101 * Additional requirements for accessories, supplementary equipment, used material <\/td>\n<\/tr>\n\n 32<\/td>\n 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 <\/td>\n<\/tr>\n\n 33<\/td>\n 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 <\/td>\n<\/tr>\n\n 34<\/td>\n 201. 9.101 * Additional requirements for suction procedures <\/td>\n<\/tr>\n \n 37<\/td>\n 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 <\/td>\n<\/tr>\n\n 38<\/td>\n 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 <\/td>\n<\/tr>\n\n 39<\/td>\n 201. 11.8.101 * Additional requirements for interruption of the power supply\/supply mains to ME equipment <\/td>\n<\/tr>\n \n 41<\/td>\n 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 <\/td>\n<\/tr>\n\n 45<\/td>\n 201. 12.1.102 * Pressure-control inflation-type <\/td>\n<\/tr>\n \n 48<\/td>\n 201. 12.1.103 Other inflation-types <\/td>\n<\/tr>\n \n 49<\/td>\n 201. 12.1.104 * Inspiratory volume monitoring
201. 12.1.105 * Response of the ventilator to an increase in set O2 concentration <\/td>\n<\/tr>\n\n 51<\/td>\n 201. 12.4 Protection against hazardous output
201. 12.4.101 Oxygen monitor <\/td>\n<\/tr>\n\n 52<\/td>\n 201. 12.4.102 * Measurement of airway pressure <\/td>\n<\/tr>\n \n 53<\/td>\n 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 <\/td>\n<\/tr>\n\n 54<\/td>\n 201. 12.4.103.2 Ventilators intended to provide a tidal volume \u226450 ml <\/td>\n<\/tr>\n \n 55<\/td>\n 201. 12.4.104 * Expiratory end-tidal CO2 monitoring equipment <\/td>\n<\/tr>\n \n 56<\/td>\n 201. 12.4.105 * Maximum limited pressure protection device
201. 12.4.106 * High airway pressure alarm condition and protection device <\/td>\n<\/tr>\n\n 57<\/td>\n 201. 12.4.107 PEEP alarm conditions <\/td>\n<\/tr>\n \n 58<\/td>\n 201. 12.4.108 * Obstruction alarm condition <\/td>\n<\/tr>\n \n 59<\/td>\n 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 <\/td>\n<\/tr>\n\n 60<\/td>\n 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 <\/td>\n<\/tr>\n\n 61<\/td>\n 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) <\/td>\n<\/tr>\n\n 62<\/td>\n 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) <\/td>\n<\/tr>\n\n 63<\/td>\n 201. 15.3.5.101.2 * Shock and vibration for a transit-operable ventilator during operation <\/td>\n<\/tr>\n \n 65<\/td>\n 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 <\/td>\n<\/tr>\n\n 66<\/td>\n 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 <\/td>\n<\/tr>\n\n 67<\/td>\n 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 <\/td>\n<\/tr>\n\n 68<\/td>\n 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 <\/td>\n<\/tr>\n\n 69<\/td>\n 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 <\/td>\n<\/tr>\n\n 70<\/td>\n 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 <\/td>\n<\/tr>\n\n 71<\/td>\n 201. 102.7.2 * Non-invasive ventilation
201. 103 * Spontaneous breathing during loss of power supply
201. 104 * Indication of duration of operation <\/td>\n<\/tr>\n\n 72<\/td>\n 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 <\/td>\n<\/tr>\n\n 73<\/td>\n 201. 106.2 Flow-volume loops
201. 107 * Timed ventilatory pause
201. 107.1 Expiratory pause <\/td>\n<\/tr>\n\n 74<\/td>\n 201. 107.2 Inspiratory pause <\/td>\n<\/tr>\n \n 75<\/td>\n 202 Electromagnetic disturbances \u2014 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 <\/td>\n<\/tr>\n\n 76<\/td>\n 206 Usability
206.101 Primary operating functions <\/td>\n<\/tr>\n\n 77<\/td>\n 206.102 * Training <\/td>\n<\/tr>\n \n 78<\/td>\n 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\u2019s 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 <\/td>\n<\/tr>\n\n 80<\/td>\n 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 <\/td>\n<\/tr>\n\n 81<\/td>\n 201.C.102 Accompanying documents, general
201.C.103 Accompanying documents, instructions for use <\/td>\n<\/tr>\n\n 84<\/td>\n 201.C.104 Accompanying documents, technical description <\/td>\n<\/tr>\n \n 85<\/td>\n Annex D (informative) Symbols on marking <\/td>\n<\/tr>\n \n 89<\/td>\n Annex AA (informative) Particular guidance and rationale
AA.1 General guidance
AA.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n\n 128<\/td>\n Annex BB (informative) Data interfaces
BB.1 Background and purpose <\/td>\n<\/tr>\n\n 129<\/td>\n BB.2 Data definition <\/td>\n<\/tr>\n \n 137<\/td>\n Annex CC (informative) Reference to the essential principles <\/td>\n<\/tr>\n \n 140<\/td>\n Annex DD (informative) Reference to the general safety and performance requirements <\/td>\n<\/tr>\n \n 143<\/td>\n Annex EE (informative) Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n \n 148<\/td>\n Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical electrical equipment – Particular requirements for basic safety and essential performance of critical care ventilators<\/b><\/p>\n
\n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n BSI<\/b><\/a><\/td>\n 2020<\/td>\n 154<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":278045,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-278042","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/278042","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/278045"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=278042"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=278042"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=278042"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}