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FprEN ISO 80601-2-85
Edition
03/2021
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO/FDIS 80601-2-85:2020)
At present no electronic version for this standard online for following language version(s): EN, FR.
Please feel free to contact normalisation@ilnas.etat.lu
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO/FDIS 80601-2-85:2020)
At present no electronic version for this standard online for following language version(s): EN, FR.
Please feel free to contact normalisation@ilnas.etat.lu
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Abstract
This particular standard applies to basic safety and essential performance of cerebral tissue oximeter equipment (t-NIRS), which is a unique application of NIRS in that it employs multiple wavelengths of light energy and time-resolved (frequency or time domain) and/or spatially resolved methods to derive a quantitative measure of tissue oxygen saturation of haemoglobin within the field of the NIRS sensor. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME EQUIPMENT for those environments of use.
Not included within the scope of this particular standard are:
a) Invasive tissue or vascular oximeters
b) Device measuring dissolved oxygen
c) Functional NIRS device covered by IEC 80601-2-71, where not intended for obtaining cerebral tissue oximeter signals for monitoring purposes
d) Pulse oximeter covered by ISO 80601-2-61, where not intended for obtaining cerebral tissue oximeter signals for monitoring purposes; however, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use.
NOTE: a manufacturer may claim monitoring of tissue other than cerebral, which is not covered
by this standard.
Status
| Final draft - Active |
Origin
| Technical Committee : |
| CEN/TC 215 : Respiratory and anaesthetic equipment |
Implementation
| start of the vote on the project | 12/03/2020 | date of ratification (dor) | 18/01/2021 | |||
| end of the vote on the project | 01/06/2020 | date of anouncement (doa) | 18/06/2021 | |||
| start of the vote on the final project | 22/10/2020 | date of publication (dop) | 20/09/2021 | |||
| end of the vote on the final project | 18/12/2020 | date of withdrawal (dow) | 20/09/2021 |
|
Publication Official Journal
of the Grand-Duchy of Luxembourg |
|
| Reference |
Relations
| Relations to international standards |
| 80601-2-85 |
| ISO 80601-2-85 |
International Classification for Standards (ICS codes) :
| 11.040.10 : Anaesthetic, respiratory and reanimation equipment |
