IEC 60601\u20111:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:<\/p>\n
\nNOTE The general standard is IEC 60601\u20111:2005+AMD1:2012+AMD2:2020.<\/p>\n<\/blockquote>\n
201.1.1<\/b> Scope<\/p>\n
IEC 60601\u20111:2005+Amendment 1:2012, 1.1 is replaced by:<\/p>\n
This document is applicable to the basic safety<\/i> and essential performance<\/i> of sleep apnoea breathing therapy equipment<\/i>, hereafter referred to as ME equipment,<\/i> intended to alleviate the symptoms of patients<\/i> who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment<\/i> is intended for use in the home healthcare environment<\/i> by lay operators<\/i> as well as in professional healthcare institutions.<\/p>\n
* Sleep apnoea breathing therapy equipment<\/i> is not considered to utilize a physiologic closed-loop-control system<\/i> unless it uses a physiological patient<\/i> variable to adjust the therapy settings.<\/p>\n
This document excludes sleep apnoea breathing therapy equipment<\/i> intended for use with neonates.<\/p>\n
This document is applicable to ME equipment<\/i> or an ME system<\/i> intended for those patients<\/i> who are not dependent on mechanical ventilation.<\/p>\n
This document is not applicable to ME equipment<\/i> or an ME system<\/i> intended for those patients<\/i> who are dependent on mechanical ventilation such as patients<\/i> with central sleep apnoea.<\/p>\n
This document is also applicable to those accessories<\/i> intended by their manufacturer<\/i> to be connected to sleep apnoea breathing therapy equipment<\/i>, where the characteristics of those accessories<\/i> can affect the basic safety<\/i> or essential performance<\/i> of the sleep apnoea breathing therapy equipment<\/i>.<\/p>\n
Masks<\/i> and application accessories<\/i> intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.<\/p>\n
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
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 7.2.13 and 8.4.1 of the general standard.<\/p>\n
\nNOTE See also 4.2 of the general standard.<\/p>\n<\/blockquote>\n
This document is not applicable to high\u2010frequency jet ventilators (HFJVs) or high\u2010frequency oscillatory ventilators (HFOVs), which are given in ISO 80601\u20112\u201187[13]<\/sup>.<\/p>\n
This document does not specify the requirements for ventilators or accessories<\/i> intended for critical care ventilators for ventilator\u2010dependent patients,<\/i> which are given in ISO 80601\u20112\u201112.<\/p>\n
This document does not specify the requirements for ventilators or accessories<\/i> intended for anaesthetic applications, which are given in ISO 80601\u20112\u201113[8]<\/sup>.<\/p>\n
This document does not specify the requirements for ventilators or accessories<\/i> intended for home care ventilators for ventilator\u2010dependent patients,<\/i> which are given in ISO 80601\u20112\u201172[9]<\/sup>.<\/p>\n
This document does not specify the requirements for ventilators or accessories<\/i> intended for emergency and transport, which are given in ISO 80601\u20112\u201184[12]<\/sup>.<\/p>\n
This document does not specify the requirements for ventilators or accessories<\/i> intended for home\u2010care ventilatory support, which are given in ISO 80601\u20112\u201179[10]<\/sup> and ISO 80601\u20112\u201180[11]<\/sup>.<\/p>\n
201.1.2<\/b> Object<\/p>\n
IEC 60601\u20111:2005, 1.2 is replaced by:<\/p>\n
The object of this document is to establish particular basic safety<\/i> and essential performance<\/i> requirements for sleep apnoea breathing therapy equipment<\/i> (as defined in 201.3.215).<\/p>\n
\nNOTE 1 This document has been prepared to address the relevant essential principles<\/i>[17]<\/sup> and labelling[18]<\/sup> guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.<\/p>\n<\/blockquote>\n
\nNOTE 2 This document has been prepared to address the relevant essential principles of safety and performance<\/i> of ISO 16142\u20111:2016 as indicated in Annex DD.<\/p>\n<\/blockquote>\n
\nNOTE 3 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017\/745[16]<\/sup> as indicated in Annex EE.<\/p>\n<\/blockquote>\n
201.1.3<\/b> Collateral standards<\/p>\n
IEC 60601\u20111:2005+AMD1:2012+AMD2:2020, 1.3 applies with the following addition:<\/p>\n
IEC 60601\u20111\u20112:2014+AMD1:2020 and IEC 60601\u20111\u20116:2010+AMD1:2013+AMD2:2020 apply as modified in Clauses 202 and 206 respectively. IEC 60601\u20111\u20113:2008+AMD1:2013 does not apply. All other published collateral standards in the IEC 60601\u20111 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 define basic safety<\/i> and essential performance<\/i> requirements, and may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME equipment<\/i> under consideration.<\/p>\n
A requirement of a particular standard takes priority over the general standard.<\/p>\n
For brevity, IEC 60601\u20111+AMD1:2012+AMD2:2020 is referred to in this 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 that 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 \u201c20x\u201d, where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of the IEC 60601\u20111\u20112 collateral standard, 203.4 in this document addresses the content of Clause 4 of the IEC 60601\u20111\u20113 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:<\/p>\n
“Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this document.<\/p>\n
“Addition” means that the text of this document is additional to the requirements of the general standard or applicable collateral standard.<\/p>\n
“Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this document.<\/p>\n
Subclauses, figures or tables which 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 3.139, 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, figures or tables which 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\u20111\u20112, 211 for IEC 60601\u20111\u201111, etc.<\/p>\n
The term “this document” is used to make reference to the general standard, any applicable collateral standards and this document taken together.<\/p>\n
Where there is no corresponding clause or subclause in this document, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this 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 12<\/td>\n 201.1. 2 Object
201.1. 3 Collateral standards
201.1. 4 Particular standards <\/td>\n<\/tr>\n\n 17<\/td>\n 201. 4.3 Essential performance
201. 4.3.101 * Additional requirements for essential performance <\/td>\n<\/tr>\n\n 18<\/td>\n 201. 4.6 * ME equipment or ME system parts that contact the patient
201. 5.101 Additional requirements for general requirements for testing of ME equipment
201. 5.101.1 Gas flowrate and pressure specifications
201. 5.101.2 * Sleep apnoea breathing therapy equipment testing errors <\/td>\n<\/tr>\n\n 19<\/td>\n 201. 7.1.2 * Legibility of markings
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 20<\/td>\n 201. 7.2.101 Additional requirements for marking on the outside of ME equipment or ME equipment parts
201. 7.4.3 Units of measurement <\/td>\n<\/tr>\n\n 21<\/td>\n 201. 7.9.1 * Additional general requirements
201. 7.9.2 Instructions for use
201. 7.9.2.1.101 Additional general requirements
201. 7.9.2.2.101 Additional requirements for warnings and safety notices <\/td>\n<\/tr>\n\n 22<\/td>\n 201. 7.9.2.5.101 Additional requirements for ME equipment description
201. 7.9.2.9.101 Additional requirements for operating instructions <\/td>\n<\/tr>\n\n 23<\/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
201. 7.9.3.1.101 * Additional general requirements <\/td>\n<\/tr>\n\n 25<\/td>\n 201. 9.6.2.1.101 * Additional requirements for audible acoustic energy <\/td>\n<\/tr>\n \n 26<\/td>\n 201. 11.1.2.2 Applied parts not intended to supply heat to a patient <\/td>\n<\/tr>\n \n 27<\/td>\n 201. 11.6.6 * Cleaning and disinfection of ME equipment or ME system
201. 11.7 Biocompatibility of ME equipment and ME systems <\/td>\n<\/tr>\n\n 28<\/td>\n 201. 11.8 Additional requirements for interruption of the power supply\/supply mains to ME equipment <\/td>\n<\/tr>\n \n 29<\/td>\n 201. 12.1 * Accuracy of controls and instruments
201. 12.1.101 Stability of static airway pressure accuracy (long-term accuracy) <\/td>\n<\/tr>\n\n 30<\/td>\n 201. 12.1.102 Stability of dynamic airway pressure accuracy (short-term accuracy)
201. 12.1.102.1 CPAP mode <\/td>\n<\/tr>\n\n 32<\/td>\n 201. 12.1.102.2 Bi-level positive airway pressure mode, pressure stability <\/td>\n<\/tr>\n \n 34<\/td>\n 201. 12.1.103 * Maximum flowrate <\/td>\n<\/tr>\n \n 35<\/td>\n 201. 12.4 Protection against hazardous output
201. 12.4.101 Measurement of airway pressure
201. 12.4.102 * Maximum limited pressure protection device <\/td>\n<\/tr>\n\n 36<\/td>\n 201. 12.4.103 * CO2 rebreathing
201. 15.101 Mode of operation <\/td>\n<\/tr>\n\n 37<\/td>\n 201.101. 1 General
201.101. 2 Other named ports
201.101. 2.1 Patient-connection port
201.101. 2.2 Gas output port <\/td>\n<\/tr>\n\n 38<\/td>\n 201.101. 2.3 Flow-direction-sensitive components
201.101. 2.4 Ancillary port
201.101. 2.5 Monitoring probe port
201.101. 2.6 Oxygen inlet port
201.102. 1 * General <\/td>\n<\/tr>\n\n 39<\/td>\n 201.102. 2 Labelling
201.102. 3 Humidification
201.102. 4 Breathing system filter (BSF)
201.103. 1 General <\/td>\n<\/tr>\n\n 40<\/td>\n 201.103. 2 * Functional connection to support remote supervision <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical electrical equipment – Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment<\/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 80<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":361815,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-361809","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\/361809","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\/361815"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=361809"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=361809"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=361809"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}