Compliant with:
21 CFR 11 Requirements for Electronic Signatures
21 CFR 211.25 Requirements for Training
21 CFR Part 606.140, 606.160 Blood Bank Regulations
21 CFR 806, 820 Quality System Requirements
FDA Docket No. 93-394 - Guidelines for Quality Assurance in Blood Banks
Accuracy, Resolution, and Range Requirements of National Committee for Clinical Laboratories (NCCLS) per 116-T
Approvals:
Safety Certificates - UL 3121-1, EN 61011, IEC 61010-1
EMC - FCC Part 15-A, EN 61326, EN 55011
CE- EN 61326-1:1997 A1:1988
CAN/CSA - C22.2 No. 1010.1-92, “Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements.”