List Of Applicable Standards - Hillrom Allen Yellofins Apex Instrucciones De Uso

INSTRUCTIONS FOR USE
5.

List of Applicable Standards:

Sl. no Standards
1 IEC 60601-1 Edition 3.1
2 IEC 60601-2-46
–Medical electrical
equipment -Part 2-46
3 EN/ISO 10993-1
4 EN/ISO 10993-5
5 EN/ISO 10993-10
Document Number: 80028475
Version: A
General requirements for basic safety and essential
performance.
Particular requirements for the basic safety and
essential performance of operating tables.
Biological evaluation of medical devices Part 1:
Evaluation and testing within a risk management
process.
Biological evaluation of medical devices Part 5: Tests
for in vitro cytotoxicity.
Biological evaluation of medical devices Part 10:
Tests for irritation and skin sensitization.
Page 42
English
Description
Issue Date: 26 November 2020
Ref Blank Template: 80025117 Ver. F