List Of Applied And Reference Standards; Applied Standards - KONG Italy X-TRIM 4 Manual

CHAPTER

11.1 APPLIED STANDARDS

• EN 597-1: 2015
Furniture - Assessment of the ignitability of mattresses and upholstered bed bases -
Part 1: Ignition source smouldering cigarette
• EN 1865-1: 2010 + A1: 2015
Patient handling equipment used in road ambulances - Part 1: General stretcher
systems and patient handling equipment
• EN 62366-1: 2015 + A1: 2020
Medical devices - Application of usability engineering to medical devices
• EN ISO 846:2019
Plastics - Evaluation of the action of microorganisms
• EN ISO 10993-1: 2020
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process
• EN ISO 10993-5: 2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
• EN ISO 10993-23: 2021
Biological evaluation of medical devices - Part 23: Tests for irritation
• EN ISO 14971: 2019
Medical devices - Application of risk management to medical devices
• EN ISO 15223-1: 2021
Medical devices — Symbols to be used with information to be supplied by the
manufacturer — Part 1: General requirements
• EN ISO 20417: 2021
Medical devices - Information to be supplied by the manufacturer.
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11
Original version in Italian dated 10/01/2022
LIST OF APPLIED AND
REFERENCE STANDARDS
23
855.12 X-TRIM 4