The scope of the Amendment is the same as EN 61010-2-101:2017. It applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.

  • Amendment
    17 pages
    English language
    e-Library read for
    1 day

Frequently Asked Questions

CLC/TC 66X/WG 4 is a Working Group within CLC. It is named "IVDD" and is responsible for: To support the standard EN 61010-2-101 This committee has published 1 standards.

CLC/TC 66X/WG 4 develops CLC standards in the area of Information technology. The scope of work includes: To support the standard EN 61010-2-101 Currently, there are 1 published standards from this working group.

CLC is a standardization organization that develops and publishes standards to support industry, commerce, and regulatory requirements.

A Working Group in CLC is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.