I.S. EN ISO 80601-2-61:2019&LC:2019
Current
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017)
Hardcopy , PDF
English
04-25-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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.
| Committee |
TC 121
|
| DocumentType |
Standard
|
| Pages |
110
|
| ProductNote |
THIS STANDARD ALSO REFERS TO- IEC 60417, ASTM F2761‐14, ISO 11073‐10404:2010 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THE CORRECTED VERSION AVAILABLE FOR THIS STANDARD
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-61:2017 | Identical |
| EN ISO 80601-2-61:2019 | Identical |
| EN ISO 80601-2-61:2011 | Identical |
| DIN EN ISO 80601-2-61:2019-09 | Equivalent |
| BS EN ISO 80601-2-61:2019 | Equivalent |
| UNE-EN ISO 80601-2-61:2019 | Equivalent |
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