BS EN ISO 80601-2-61:2019
$215.11
Medical electrical equipment – Particular requirements for basic safety and essential performance of pulse oximeter equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 102 |
IEC 60601‐1:2005+AMD1:2012, Clause 1 applies, except as follows:
201.1.1 * Scope
Replacement:
This document applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed.
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment.
This document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.
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 201.11 and in 7.2.13 and 8.4.1 of the general standard.
NOTE 1 See also 4.2 of the general standard. “The general standard” is IEC 60601‐1:2005+AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
This document can also be applied to me equipment and their accessories used for compensation or alleviation of disease, injury or disability.
This document is not applicable to pulse oximeter equipment intended solely for foetal use.
This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.
NOTE 2 Me equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.
This document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply pulse oximeter equipment for those environments of use.
This document is a particular standard in the IEC 60601‐1 and ISO/IEC 80601 series of standards.
201.1.2 Object
Subclause 1.2 of the general standard is replaced by:
The object of this document is to establish particular basic safety and essential performance requirements for pulse oximeter equipment [as defined in 201.3.217] and its accessories.
NOTE Accessories are included because the combination of the pulse oximeter monitor and the accessories needs to be adequately safe. accessories can have a significant impact on the basic safety or essential performance of pulse oximeter equipment.
201.1.3 Collateral standards
IEC 60601‐1:2005+AMD1:2012, subclause 1.3 applies with the following addition:
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.
IEC 60601‐1‐2, IEC 60601‐1‐6, IEC 60601‐1‐8, IEC 60601‐1‐11 and IEC 60601‐1‐12 apply as modified in Clauses 202, 206, 208, 211 and 212 respectively. IEC 60601‐1‐3[2] does not apply. All other published collateral standards in the IEC 60601‐1 series apply as published.
201.1.4 Particular standards
IEC 60601‐1:2005+AMD1:2012, subclause 1.4 is replaced by:
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 the general standard or the collateral standards.
For brevity, IEC 60601‐1:2005+AMD1:2012 is referred to in this 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 the general standard or 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 the general standard or applicable collateral standard.
“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.
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), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting from 2xx, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601‐1‐2, 203 for IEC 60601‐1‐3, 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 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 4 | European foreword Endorsement notice |
| 11 | 201. 1 Scope, object and related standards 201. 1.1 * Scope |
| 12 | 201. 1.2 Object 201. 1.3 Collateral standards 201. 1.4 Particular standards |
| 13 | 201. 2 Normative references |
| 14 | 201. 3 Terms and definitions |
| 19 | 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 |
| 20 | 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 |
| 21 | 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 |
| 22 | 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 |
| 23 | 201. 7.9.2.2.101 Additional requirements for warnings and safety notices |
| 24 | 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 |
| 25 | 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 |
| 26 | 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 |
| 27 | 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 |
| 28 | 201. 12.1.101.2 * Data collection for determination of SpO2 accuracy |
| 29 | 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 |
| 30 | 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 |
| 31 | 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 |
| 32 | 201. 15.101 Mode of operation |
| 33 | 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 |
| 34 | 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 – Requirements and tests 202.4.3.1 Configurations 202.5.2.2.1 Requirements applicable to all me equipment and me systems |
| 35 | 202.8.1.101 Additional general requirements 202.8.2 Patient physiological simulation 206 Usability |
| 36 | 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 |
| 37 | 212 Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment |
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BS EN ISO 80601-2-61:2019
Medical electrical equipment – Particular requirements for basic safety and essential performance of pulse oximeter…
