bbluv Rino Bedienungsanleitung Seite 2

EN FR ES DE IT PT
APPLIED STANDARDS:
This device conforms to the provisions of the EU 2017/745 Medical Device Regulation
(MDR).
The following standards apply to the design and manufacture of the device:
• IEC/EN 60601-1 Medical Electrical Equipment – Part 1: General requirements for basic
safety and essential performance
• IEC/EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements
for basic safety and essential performance – Collateral Standard: Electromagnetic
compatibility – Requirements and tests
• IEC/EN 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for
safety – Collateral standard: Usability
• IEC/EN 60601-1-11 Medical electrical equipment – Part 1-11: General requirements
for basic safety and essential performance – Collateral Standard: Requirements
for medical electrical equipment and medical electrical systems used in the home
healthcare environment
• EN ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity
• EN ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin
sensitization
• EN ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
Asia Connection Co., Ltd. 16 F-1, NO. 16, Jian Ba Rd.,
Chung Ho District, New Taipei City 235603, Taiwan
EC REP
Advena Ltd. Tower Business Centre, 2nd Flr, Tower Street, Swatar, BKR 4013, Malta
Rinö