ISO 80601-2-61:2011
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Hardcopy , PDF
English, French, Russian
16-03-2011
09-04-2025
ISO 80601-2-61:2011 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.
ISO 80601-2-61:2011 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.
ISO 80601-2-61:2011 can also be applied to pulse oximeter equipment and their accessories used for compensation or alleviation of disease, injury or disability.
ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended solely for foetal use.
ISO 80601-2-61:2011 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.
| Committee |
ISO/TC 121/SC 3
|
| DocumentType |
Standard
|
| Pages |
83
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| JIS T 80601-2-61:2014 | Identical |
| BS EN ISO 80601-2-61:2011 | Equivalent |
| I.S. EN ISO 80601-2-61:2011 | Equivalent |
| NBR ISO 80601-2-61 : 2015 | Identical |
| EN ISO 80601-2-61:2011 | Identical |
| NEN EN ISO 80601-2-61 : 2011 | Identical |
| BS EN ISO 80601-2-61:2011 | Identical |
| OVE/ONORM EN ISO 80601-2-61 : 2012 | Identical |
| VDE 0750-2-61 : 2012 | Identical |
| I.S. EN ISO 80601-2-61:2011 | Identical |
| DS EN ISO 80601-2-61 : 2011 | Identical |
| NF EN ISO 80601-2-61 : 2011 | Identical |
| NBN EN ISO 80601-2-61 : 2011 | Identical |
| PN EN ISO 80601-2-61 : 2011 | Identical |
| DIN EN ISO 80601-2-61 : 2012 | Identical |
| NS EN ISO 80601-2-61 : 2011 | Identical |
| UNE-EN ISO 80601-2-61:2011 | Identical |
A newer version of this standard is available.
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.