BS EN ISO 18113-3:2011
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments for professional use
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments for professional use
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Дата публикации:
- 30 ноября 2011 г.
- ICS:
- 11.100.10
- Технический комитет:
- CEN
- SKU:
- BS EN ISO 18113-3:2011
Abstract
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 us...
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