UL 61010-2-101 PDF

1 Scope and object

This clause of Part 1 is applicable except as follows:

Replacement:

Replace the text, except the first paragraph, with the following new text:

This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.

IVD medical equipment, whether used alone or in combination, is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning one or more of the following:

• a physiological or pathological state; or

• a congenital abnormality;

• the determination of safety and compatibility with potential recipients;

• the monitoring of therapeutic measures.

Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in a home environment.

NOTE If all or part of the equipment falls within the scope of one or more other Part 2 standards of the IEC 61010 series as well as within the scope of this document, consideration is given to those other Part 2 standards.

Summary of Topics

This revision of ANSI/UL 61010-2-101 dated December 7, 2023 is being issued to update the title page to reflect the most recent designation as a Reaffirmed American National Standard (ANS). No technical changes have been made.

UL 61010-2-101 is an adoption of 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 (third edition, issued by IEC October 2018) as an IEC-based UL standard with No US Differences.