BS EN ISO 18113-5:2011

In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments for self-testing

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This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing.

This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.

This part of ISO 18113 can also be applied to accessories.

This part of ISO 18113 does not apply to

a) instructions for instrument servicing or repair,
b) IVD reagents, including calibrators and control materials for use in control of the reagent,
c) IVD instruments for professional use.

Product Details

Descriptors

Clinical investigation instruments

Instructions for use

Product information

Medical equipment

Labels

Clinical laboratory equipment

Labelling (process)

Diagnosis (medical)

Consumers

ICS Codes

11.100.10 In vitro diagnostic test systems

Committee

CH/212

International relationships

Identical to:

EN ISO 18113-5:2011

ISO 18113-5:2009

ISBN

978 0 580 77330 3

Publisher

BSI