List Of Applied And Reference Standards; Applied Standards; Standards Used For Reference - Kong HALF ROLLY 890.02 Manual Del Usuario

CHAPTER

11.1 APPLIED STANDARDS

• CEI UNI EN ISO 14971 - Class. CEI 62-121 - CT 62 - Dossier 12929 - Year 2013
Medical devices - Application of risk management to medical devices.
• CEI EN 62366 - Class. CEI 62-147 - CT 62 - Dossier 9510 E - Year 2008 - First Edition
Medical devices - Application of usability engineering to medical devices
• CEI UNI EN ISO 15223-1 - Class. CEI 62-234 - CT 62 - Dossier 12811 - Year 2013
Medical devices - Symbols to be used with medical device labels, labelling and information
to be supplied Part 1: General requirements.

11.2 STANDARDS USED FOR REFERENCE

• CEI UNI EN ISO 13485 - Year 2012 Medical devices - Quality management systems -
Requisites for regulatory purposes
• UNI EN 1865-1 - ICS 11.160 - Year 2015
Patient Handling Equipment Used In Road Ambulances - Part 1: General Stretcher
Systems And Patient Handling Equipment
• UNI EN 13718-1 - Year 2014
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for
medical devices used in air ambulances
www.kong.it
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Original version in Italian dated 24/01/2017
LIST OF
APPLIED
AND REFERENCE
STANDARDS
890.02 HALF ROLLY
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