STN EN ISO 80601-2-61
| Name: | STN EN ISO 80601-2-61 |
| Validity: | Valid |
| Number of pages: | 104 |
| Language: |
EN
|
| Paper: | 31,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
28,62€ b) Without ability to print, with ability to copy (printscreen) 31,80€ c) With ability to print and copy (printscreen) 41,34€ |
| Slovak title | Zdravotnícke elektrické prístroje. Časť 2-61: Osobitné požiadavky na základnú bezpečnosť a podstatné vlastnosti pulzových oxymetrov na zdravotnícke používanie (ISO 80601-2-61: 2017) |
| English title | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017) |
| Release Date: | 01. 07. 2019 |
| Date of withdrawal: | |
| ICS: | 11.040.10, 11.040.55 |
| Sorting character/National clasification code | 85 2159 |
| Level of incorporation: | idt EN ISO 80601-2-61:2019, idt ISO 80601-2-61:2017 |
| Official Journal | 06/19 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 80601-2-61:2011-08 (85 2159) |
| Note in Official Journal: | |
| Subject of the standard: | ISO 80601-2-61:2017 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. ISO 80601-2-61:2017 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. |
| Preview: | Náhľad normy (PDF) |