What is ISO 18113-3 - In vitro diagnostic instruments for professional use about?
ISO 18113 is a European standard that discusses information supplied by the manufacturer regarding In vitro diagnostic medical devices. BS EN ISO 18113-3 is the third part of a multi-part series that outlines the requirements for information supplied by the manufacturer of IVD instruments for professional use to ensure the safe use of In vitro diagnostic instruments.
ISO 18113-3 applies to apparatus and equipment intended to be used with IVD instruments for professional use.
ISO 18113-3 can also be applied to accessories.
Note: ISO 18113-3 does not apply to:
- Instructions for instrument servicing or repair
- IVD reagents, including calibrators and control materials for use in the control of the reagent
- IVD instruments for self-testing
Who is ISO 18113-3 - In vitro diagnostic instruments for professional use for?
ISO 18113-3 on the In vitro diagnostic instruments for professional use are useful for:
- Manufacturers of In vitro diagnostic medical devices
- Operators of In vitro diagnostic medical devices
- Regulatory bodies
Why should you use ISO 18113-3 - In vitro diagnostic instruments for professional use?
Manufacturers of in vitro diagnostic (IVD) instruments supply users with information to enable the safe use and expected performance of their devices. The type and level of detail vary according to the intended uses and country-specific regulations.
ISO 18113-3 guideline assists you with the essential requirements, labels, marking, and elements of the instructions for use of In vitro diagnostic instruments for professional use.
ISO 18113-3 guides on the content of the instructions for use by the manufacturer, identification of the IVD instrument, intended use, storage, handling, warnings, precautions, instrument installation, theory of operation, functions, performance of the IVD instrument, limitations of use, preparation before the operation, operating procedure, control procedure, special functions, shut-down procedure, disposal information, maintenance, and troubleshooting for In vitro diagnostic instruments for professional use.
This assists in manufacturing efficient In vitro diagnostic instruments that are durable and of high quality.
With obedience and compliance to ISO 18113-3, you can enhance the efficacy and safety of In vitro diagnostic instruments. In addition, ensure safe use and expected performance of the devices.
