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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

Abbott i-STAT Alinity User Manual

Other manuals for Abbott i-STAT Alinity