List Of Applied And Reference Standards; Applied Standards; Standards Used As Reference - KONG Italy 911 CANYON Manual De Instrucciones

CHAPTER

11.1 APPLIED STANDARDS

• EN 1041:2008
Information provided by the medical devices manufacturer
• EN ISO 14971:2012
Medical devices - Risk management implementation for medical devices
• EN ISO 15223-1:2016
Medical devices - symbols to be used on the labels of the medical device, in the labelling
and information that must be provided - Part 1: General requirements
• EN 62366:2008
Medical devices – Application of engineering for the exploitative characteristics of medical
devices

11.2 STANDARDS USED AS REFERENCE

• EN 1865-1:2010+A1:2015
Patient transportation equipment used in ambulances - Part 1: General systems for
stretchers and patient transportation equipment
• EN ISO 13485:2016
Medical devices: quality management systems; requirements for regulatory purposes
• EN 13718-1:2008
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical
devices used in air ambulances
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original version in Italian dated 22/07/2016
LIST OF APPLIED
AND REFERENCE
STANDARDS