JB02020-INS-LAB-RevA20 • Fingertip Oximeter User Manual
10
Declaration of Conformity
This device complies with the following standards:
IEC 60601-1: 2005 Medical electrical equipment-Part 1: General
requirements for basic safety and essential performance;
BS/EN/ISO 9919:2009 or the equivalent ISO 80601-2-61:2011 -
Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance of
pulse Oximeter equipment.
And it also follows the provisions of the council directive MDD
93/42/EEC.
Содержание John Bunn JB02020
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