IEC 60601\u20101:2005+AMD1:2012, Clause 1 applies, except as follows:<\/p>\n
201.1.1<\/b> * Scope<\/p>\n
Replacement:<\/i><\/p>\n
This document applies to the basic safety<\/small> and essential performance<\/small> of pulse oximeter equipment<\/small> intended for use on humans, hereafter referred to as me equipment<\/small>. This includes any part necessary for normal use<\/small>, including the pulse oximeter monitor<\/small>, pulse oximeter probe<\/small>, and probe cable extender<\/small>.<\/p>\n
These requirements also apply to pulse oximeter equipment<\/small>, including pulse oximeter monitors<\/small>, pulse oximeter probes<\/small> and probe cable extenders<\/small>, which have been reprocessed<\/small>.<\/p>\n
The intended use of pulse oximeter equipment<\/small> includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients<\/small> in professional healthcare institutions as well as patients<\/small> in the home healthcare environment<\/small> and the emergency medical services environment<\/small>.<\/p>\n
This document is not applicable to pulse oximeter equipment<\/small> intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient<\/small>.<\/p>\n
If a clause or subclause is specifically intended to be applicable to me equipment<\/small> only, or to me systems<\/small> 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<\/small> and to me systems<\/small>, as relevant.<\/p>\n
Hazards<\/small> inherent in the intended physiological function of me equipment<\/small> or me systems<\/small> within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 7.2.13 and 8.4.1 of the general standard.<\/p>\n NOTE 1 See also 4.2 of the general standard. \u201cThe general standard\u201d is IEC 60601\u20101:2005+AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance<\/i>.<\/p>\n<\/blockquote>\n This document can also be applied to me equipment<\/small> and their accessories<\/small> used for compensation or alleviation of disease, injury or disability.<\/p>\n This document is not applicable to pulse oximeter equipment<\/small> intended solely for foetal use.<\/p>\n This document is not applicable to remote or slave (secondary) equipment that displays Sp<\/i>O2<\/sub> values that are located outside of the patient environment<\/small>.<\/p>\n NOTE 2 Me equipment<\/small> that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.<\/p>\n<\/blockquote>\n This document is applicable to pulse oximeter equipment<\/small> intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician\u2019s office, such as in ambulances and air transport. Additional standards can apply pulse oximeter equipment<\/small> for those environments of use.<\/p>\n This document is a particular standard in the IEC 60601\u20101 and ISO\/IEC 80601 series of standards.<\/p>\n 201.1.2<\/b> Object<\/p>\n Subclause 1.2 of the general standard is replaced by:<\/p>\n The object of this document is to establish particular basic safety<\/small> and essential performance<\/small> requirements for pulse oximeter equipment<\/small> [as defined in 201.3.217] and its accessories<\/small>.<\/p>\n NOTE Accessories<\/small> are included because the combination of the pulse oximeter monitor<\/small> and the accessories<\/small> needs to be adequately safe. accessories<\/small> can have a significant impact on the basic safety<\/small> or essential performance<\/small> of pulse oximeter equipment<\/small>.<\/p>\n<\/blockquote>\n 201.1.3<\/b> Collateral standards<\/p>\n IEC 60601\u20101:2005+AMD1:2012, subclause 1.3 applies with the following addition:<\/p>\n This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this document.<\/p>\n IEC 60601\u20101\u20102, IEC 60601\u20101\u20106, IEC 60601\u20101\u20108, IEC 60601\u20101\u201011 and IEC 60601\u20101\u201012 apply as modified in Clauses 202, 206, 208, 211 and 212 respectively. IEC 60601\u20101\u20103[2]<\/sup> does not apply. All other published collateral standards in the IEC 60601\u20101 series apply as published.<\/p>\n 201.1.4<\/b> Particular standards<\/p>\n IEC 60601\u20101:2005+AMD1:2012, subclause 1.4 is replaced by:<\/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<\/small> under consideration, and may add other basic safety<\/small> or essential performance<\/small> requirements.<\/p>\n A requirement of a particular standard takes priority over the general standard or the collateral standards.<\/p>\n For brevity, IEC 60601\u20101:2005+AMD1:2012 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 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\u20101\u20102 collateral standard, 208.4 in this document addresses the content of Clause 4 of the IEC 60601\u20101\u20108 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 or figures that are additional to those of the general standard are numbered starting from 201.101, 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 2xx, where \u201cx\u201d is the number of the collateral standard, e.g. 202 for IEC 60601\u20101\u20102, 203 for IEC 60601\u20101\u20103, etc.<\/p>\n The term “this document” 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 section, 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 particular document.<\/p>\n Medical electrical equipment – Particular requirements for basic safety and essential performance of pulse oximeter equipment<\/b><\/p>\n\n
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PDF Catalog<\/h4>\n
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\n PDF Pages<\/th>\n PDF Title<\/th>\n<\/tr>\n \n 2<\/td>\n undefined <\/td>\n<\/tr>\n \n 4<\/td>\n European foreword
Endorsement notice <\/td>\n<\/tr>\n\n 11<\/td>\n 201. 1 Scope, object and related standards
201. 1.1 * Scope <\/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 13<\/td>\n 201. 2 Normative references <\/td>\n<\/tr>\n \n 14<\/td>\n 201. 3 Terms and definitions <\/td>\n<\/tr>\n \n 19<\/td>\n 201. 4 General requirements
201. 4.3 Essential performance
201. 4.3.101 * Additional requirements for essential performance
201. 4.102 Additional requirements for acceptance criteria <\/td>\n<\/tr>\n\n 20<\/td>\n 201. 4.103 Additional requirements for pulse oximeter equipment, parts and accessories
201. 5 General requirements for testing of me equipment
201. 6 Classification of me equipment and me systems <\/td>\n<\/tr>\n\n 21<\/td>\n 201. 7 Me equipment identification, marking and documents
201. 7.2.3 Consult accompanying documents
201. 7.2.9.101 IP classification
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 22<\/td>\n 201. 7.2.101 Additional requirements for marking on the outside of me equipment parts
201. 7.4.3 Units of measurement
201. 7.9.2 Instructions for use
201. 7.9.2.1.101 Additional general requirements <\/td>\n<\/tr>\n\n 23<\/td>\n 201. 7.9.2.2.101 Additional requirements for warnings and safety notices <\/td>\n<\/tr>\n \n 24<\/td>\n 201. 7.9.2.9.101 Additional requirements for operating instructions
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. 8 Protection against electrical hazards from me equipment
201. 8.3.101 Additional requirements for classification of applied parts
201. 9 Protection against mechanical hazards of me equipment and me systems
201. 10 Protection against unwanted and excessive radiation hazards
201. 10.4 Lasers
201. 11 Protection against excessive temperatures and other hazards
201. 11.1.2.2 Applied parts intended to supply heat to a patient <\/td>\n<\/tr>\n\n 26<\/td>\n 201. 11.6.5.101 * Additional requirements for ingress of water or particulate matter into me equipment or me system
201. 11.8.101 Additional requirements for interruption of the power supply\/supply mains to me equipment
201. 11.8.101.1 Technical alarm condition for power supply failure <\/td>\n<\/tr>\n\n 27<\/td>\n 201. 11.8.101.2 Settings and data storage following short interruptions or automatic switchover
201. 11.8.101.3 Operation following long interruptions
201. 12 Accuracy of controls and instruments and protection against hazardous outputs
201. 12.1 Accuracy of controls and instruments
201. 12.1.101 * SpO2 accuracy of pulse oximeter equipment
201. 12.1.101.1 * Specification <\/td>\n<\/tr>\n\n 28<\/td>\n 201. 12.1.101.2 * Data collection for determination of SpO2 accuracy <\/td>\n<\/tr>\n \n 29<\/td>\n 201. 12.1.101.3 * Data analysis for determination of SpO2 accuracy
201. 12.1.101.4 Characteristics of the clinical study population for determination of SpO2 accuracy
201. 12.1.102 Accuracy under conditions of motion <\/td>\n<\/tr>\n\n 30<\/td>\n 201. 12.1.103 Accuracy under conditions of low perfusion
201. 12.1.104 Pulse rate accuracy
201. 12.4 Protection against hazardous output
201. 12.4.101 * Data update period
201. 12.4.102 * Signal inadequacy <\/td>\n<\/tr>\n\n 31<\/td>\n 201. 13 Hazardous situations and fault conditions for me equipment
201. 13.101 Detection of probe faults and probe cable extender faults
201. 14 Programmable electrical medical systems (pems)
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 <\/td>\n<\/tr>\n\n 32<\/td>\n 201. 15.101 Mode of operation <\/td>\n<\/tr>\n \n 33<\/td>\n 201. 16 Me systems
201. 17 Electromagnetic compatibility of me equipment and me systems
201. 101 * Pulse oximeter probes and probe cable extenders
201. 101.1 General
201. 101.2 Labelling
201. 102 Saturation pulse information signal <\/td>\n<\/tr>\n\n 34<\/td>\n 201. 103 Functional connection
201. 103.1 General
201. 103.2 * Connection to electronic health record
201. 103.3 Connection to a distributed alarm system
202 Electromagnetic disturbances \u2013 Requirements and tests
202.4.3.1 Configurations
202.5.2.2.1 Requirements applicable to all me equipment and me systems <\/td>\n<\/tr>\n\n 35<\/td>\n 202.8.1.101 Additional general requirements
202.8.2 Patient physiological simulation
206 Usability <\/td>\n<\/tr>\n\n 36<\/td>\n 206.5 Replacement of requirements given in IEC 62366[19]
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.6.1.2.101 * Additional requirements for alarm condition priority
208.6.5.4.101 * Additional requirements for default alarm preset
208.6.8.5.101 Additional requirements for alarm signal inactivation states, indication and access
211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment <\/td>\n<\/tr>\n\n 37<\/td>\n 212 Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" \n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n BSI<\/b><\/a><\/td>\n 2019<\/td>\n 102<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":278217,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[143,2641],"product_tag":[],"class_list":{"0":"post-278212","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-55","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\/278212","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\/278217"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=278212"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=278212"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=278212"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}