Abbott i-STAT Alinity - Regulatory compliance; Safety Regulations; EMC Regulations; Radio;Telecommunication Regulations

Regulatory compliance
The i‑STAT Alinity system complies with applicable regulaons.
Safety Regulaons:
USA 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
Canada Cered to CSA Standard C22.2 No. 61010-1: Safety Requirements for
Electrical Equipment for Measurement, Control and Laboratory Use –
Part 1: General Requirements
European Union (EU) IEC 61010-1: Safety Requirements for Electrical Equipment for
Measurement, Control and Laboratory Use – Part 1: General
Requirements
European Union (EU) IEC 61010-2-101: Safety Requirements for Electrical Equipment for
Measurement, Control and Laboratory Use – Part 2-101: Parcular
Requirements for In Vitro Diagnosc (IVD) Medical Equipment
European Union (EU) IEC 62133: Secondary cells and baeries containing alkaline or other
non-acid electrolytes – Safety requirements for portable sealed
secondary cells, and for baeries made from them, for use in portable
applicaons
Internaonal UN Manual of Tests and Criteria “Recommendaons on the Transport of
Dangerous Goods,” Secon 38.3 “Lithium Baeries”
Internaonal IEC 60950-1: Informaon Technology Equipment–Safety–Part 1: General
Requirements
EMC Regulaons:
USA FCC 47 CFR Part 15, Subpart B, Class A (Unintenonal Radiators)
Canada CAN ICES-001 Class A, Industrial, Scienc and Medical Radio Frequency
Radiators
European Union (EU) IEC 61326-1: Electrical Equipment for measurement, control and
laboratory use – EMC requirements – Part 1: General requirements.
European Union (EU) IEC 61326-2-6: Electrical Equipment for measurement, control and
laboratory use – EMC requirements – Part 2-6: Parcular requirements –
In vitro diagnosc (IVD) medical equipment
Radio/Telecommunicaon Regulaons:
Angua & Barbuda ABTD Angua & Barbuda Telecommunicaons Division
Type Approval Cercate Number 25-TAC2513000853
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i-STAT Alinity — System Operaons Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020