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| 4 |
QUALITY STANDARDS COMPLIANCE
CERTIFICATION OF MAQUET SAS'S QUALITY SYSTEM
LN�/G-M�D certifies that the quality system developed by MAQU�T SAS for design,
implementation, sales, installation and after-sales service of surgical lights complies with the
requirements of the following international standards:
IS� 9���:����
IS� �485:���4
CE MARKING
Compliance with the requirements of �uropean Directive 9/4�/��C dated �4 June �99 relating
to medical devices was assessed as described in Annex VII of the Directive. X'T�N surgical
lights belong to Class I as described in Annex IX of Directive 9/4�/��C.
X'TEN |
User manual
| EN | 0130103 | 3A |
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