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HUMAC NORM Systems are manufactured just outside Boston in Stoughton, Massachusetts, USA. The HUMAC NORM consists of four component groups - metal fabrication, computer, electronics, and software. The manufacturing process is performed under our ISO9001 Certification Process.
Metal fabrication (cut, weld, and paint) is performed by a nearby specialty custom fabrication facility. Computers are supplied by DELL Computers, the world leader in small computer systems. Custom circuit boards are designed in-house and manufactured by a nearby fabrication house. Lastly our HUMAC Software is developed and produced in-house.
The HUMAC NORM components are gathered at our corporate facility for final assembly, testing, and packaging. We ship HUMACs worldwide, with customers throughout the US, Great Britain, and elsewhere.
Copies of our Quality Control Certifications can be downloaded by clicking the following links:
Regulatory Approvals
- CENELEC EN 60601-1-2 - 2001 - Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests IEC 60601-1-2: 2001.
- CENELEC EN 60601-1 - Medical Electrical Equipment Part 1: General Requirements for Safety Incorporates Corrigendum July 1994; Includes Amendments A1: 1993, A11: 1993, A12: 1993, A2: 1995 and A13: 1996; IEC 601-1: 1988 + A1: 1991 + A2: 1995 + Corrigendum 1995, Modified.
- UL 60601-1 - UL Standard for Safety Medical Electrical Equipment, Part 1: General Requirements for Safety First Edition.
- CSA C22.2 NO 601.1-M90 - Medical Electrical Equipment - Part 1: General Requirements for Safety General Instruction No 1; Supplement 1; 1994 R(1997).
- IEC 60601-1-1 (1992-01) - Medical Electrical Equipment Part 1: General Requirements for Safety 1. Collateral Standard: Safety Requirements for Medical Electrical Systems First Edition.
- IEC 60601-1 - Medical Electrical Equipment Part 1: General Requirements for Safety Second Edition.
- CB Scheme Report and Certificate.
CSMi Quality Certification
ISO 9001:1994 and ISO 13485:1196 with CMDCAS.
FDA Approval
US FDA 510K Pre-market approval.
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