Product Safety Compliance - Stryker SYSTEM G 7309-120-000 Instrucciones De Uso

7309-120-700 Rev-B

Product Safety Compliance

International Electrotechnical Commission (IEC)
IEC 60601-1J A1: R:2012 (3.1 Edition): Medical Electrical Equipment – Part 1: General Requirements
for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007);
Amendment 1 (2012)
IEC 60601-1-6: 2013: USABILITY – Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral standard: Usability – Edition 3.1 Consolidated
Reprint.
IEC 62366: 2014: USABILITY – Medical devices – Application of usability engineering to medical
devices - Edition 1.1 Consolidated Reprint.
IEC 60601-1-2: 2010: EMC (Version 3.0) – Medical electrical equipment – Part 1-2: General requirements
for basic safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests – Edition 3.0
IEC 62133: 2012/12/06 Edition: 2.0: Secondary Cells and Batteries Containing Alkaline or other Non-
Acid Electrolytes – Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made
from Them for use in Portable Applications, Corrigendum 1:2013
European Committee for Electrotechnical Standardization (CENELEC)
EN 60601-1:2006/A1:2013 (3.1 Edition): Medical electrical equipment Part 1: General requirements for
basic safety and essential performance – Incorporates Amendment A12: 2014
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