What is BS EN 13641 - Reduction of risk of infection related to in vitro diagnostic reagents about?
BS EN 13641 is a European standard that discusses the elimination or reduction of risk of infection related to in vitro diagnostic reagents to reduce the additional risk of accidental infection. BS EN 13641 outlines the requirements related to design and manufacture to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials, and kits, hereinafter called IVD reagents.
BS EN 13641 applies to in vitro diagnostic reagents containing material of human origin.
BS EN 13641 also applies to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, given relevant zoonoses when the results of a risk analysis reveal that there is a risk of human infection.
Note 1: BS EN 13641 does not apply to the following:
- Instruments and specimen receptacles
- General aspects of workers' protection
- Transportation of infectious goods
- Disposal measures
Note 2: Some of the most relevant documents relating to aspects not covered by BS EN 13641 are listed in Bibliography for information.
Who is BS EN 13641 - Reduction of risk of infection related to in vitro diagnostic reagents for?
BS EN 13641 on reduction of risk of infection related to in vitro diagnostic reagents is useful for:
- Manufacturers of in vitro diagnostic reagents
- In vitro diagnostic centres
- Medical laboratories
- Regulatory authorities
Why should you use BS EN 13641 - Reduction of risk of infection related to in vitro diagnostic reagents?
Although medical laboratory staff routinely handle specimens that are potentially infectious and appropriate protective measures and safety procedures must be followed, according to the provisions of Directive 98/79/EC on in vitro diagnostic medical devices (IVD MDs) the additional risk of accidental infection caused by IVD MDs containing infectious or potentially infectious material is to be reduced to a minimum.
BS EN 13641 guideline assists you with requirements related to design and manufacture, use of infectious biological materials or potentially infectious biological materials, raw material specifications, sourcing requirements, testing requirements, manufacturing process, and information supplied by the manufacturer.
With obedience and compliance to BS EN 13641, you can eliminate the risk of infection related to in vitro diagnostic reagents and ensure that the risk of infection presented by the product itself is minimal.
