This standard has been revised by ISO 18113-2:2022
Abstract
ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.
ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.
ISO 18113-2:2009 can also be applied to accessories.
ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.
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Status: WithdrawnPublication date: 2009-12
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Edition: 1Number of pages: 10
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- ICS :
- 11.100.10 In vitro diagnostic test systems
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