Regulatory Compliance - Abbott i-STAT Alinity Operation Manual

The i‑STAT Alinity system complies with applicable regulations.
Safety Regulations:
USA
Canada
European Union (EU)
European Union (EU)
European Union (EU)
International
International
EMC Regulations:
USA
Canada
European Union (EU)
European Union (EU)
Radio/Telecommunication Regulations:
Antigua & Barbuda
i-STAT Alinity — System Operations Manual

Regulatory compliance

Conforms to UL Standard 61010-1: Safety Requirements for Electrical
Equipment for Measurement, Control and Laboratory Use – Part 1:
General Requirements and IEC Standard 61010-2-101
Certified to CSA Standard C22.2 No. 61010-1: Safety Requirements for
Electrical Equipment for Measurement, Control and Laboratory Use –
Part 1: General Requirements
IEC 61010-1: Safety Requirements for Electrical Equipment for
Measurement, Control and Laboratory Use – Part 1: General
Requirements
IEC 61010-2-101: Safety Requirements for Electrical Equipment for
Measurement, Control and Laboratory Use – Part 2-101: Particular
Requirements for In Vitro Diagnostic (IVD) Medical Equipment
IEC 62133: Secondary cells and batteries containing alkaline or other
non-acid electrolytes – Safety requirements for portable sealed
secondary cells, and for batteries made from them, for use in portable
applications
UN Manual of Tests and Criteria "Recommendations on the Transport of
Dangerous Goods," Section 38.3 "Lithium Batteries"
IEC 60950-1: Information Technology Equipment–Safety–Part 1: General
Requirements
FCC 47 CFR Part 15, Subpart B, Class A (Unintentional Radiators)
CAN ICES-001 Class A, Industrial, Scientific and Medical Radio Frequency
Radiators
IEC 61326-1: Electrical Equipment for measurement, control and
laboratory use – EMC requirements – Part 1: General requirements.
IEC 61326-2-6: Electrical Equipment for measurement, control and
laboratory use – EMC requirements – Part 2-6: Particular requirements –
In vitro diagnostic (IVD) medical equipment
ABTD Antigua & Barbuda Telecommunications Division
Type Approval Certificate Number 25-TAC2513000853
Art: 746983-01 Rev. H
xiii
Rev. Date: 11-Nov-2020