CERUS INTERCEPT INT100 - Page 159

Chapter 7 – Specifications
Section 7.2 – Illuminator Compliance with Standards
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Section 7.2 Illuminator Compliance with Standards
The illuminator complies with the following Directives and Standards:
- Low Voltage Directive (LVD) 2006/95/EC
- Medical Devices Directive (MDD) 93/42/EEC
- Directive 2002/96/EC (WEEE)
- EN 1041
- EN 50419
- EN 55011
- EN 61000-3-2, EN 61000-3-3
- EN 61000-4-1, EN 61000-4-2, EN 61000-4-3, EN 61000-4-4, EN 61000-4-5,
- EN 61000-4-6, EN 61000-4-8, EN 61000-4-11
- EN 61010-1
- EN 61326-1
- EN ISO 13485
- EN ISO 14155
- EN ISO 14971
- EN ISO 15225
- ISO 7000
- ISO 7064
- ISO 9001
- ISO 15223-1
- ASTM D880-92
- ASTM D4003-98
- ASTM D4169-09
- ASTM D4332-01
- ASTM D4728-06
- ASTM D5276-98
- ASTM D5487-98
- CAN/CSA-C22.2 No. 61010-1-04+GI1 (R2009)
- UL 61010-1
MAN-EN 00601, v3.0