Medical Diode Laser Systems
Product Description
Medical Device: 980nm±10nm, 10W, 200µm
We herewith declare that the above mentioned product meet the essential requirements of the Annex II of the Directive 93/42/EEC and is classified subject to Annex IX rule 9 as a medical device of Class IIb.
The product is designed in conjunction with the following safety standards:
EN 60825-1:2007 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility- Requirements and tests.
EN 60601-1:2006 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance.
EN 60601-1-2:2007 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility- Requirements and tests.
EN 60601-1-6: 2010 Medical electrical equipment-Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
EN 60601-2-22:1996 Medical electrical equipment. Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
This declaration is based upon a Quality System meeting the requirements of EN ISO 13485:2012, EN ISO 13485:2012/AC: 2012.