ISO 18113-4:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.
ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
ISO 18113-4:2009 can also be applied to accessories, where appropriate.
ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.
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Scope
Normative references
Terms and definitions
General
Essential requirements
Identification of kit components
Presentation of the instructions for use
Content of the outer container label
Manufacturer
Identification of the IVD reagent
IVD reagent name
Batch code
Contents
Intended use
In vitro diagnostic use
Storage and handling conditions
Expiry date
Warnings and precautions
Content of the immediate container label
General provisions
Single container
Small label
Manufacturer
Identification of the IVD reagent
IVD reagent or component name
Batch code
Contents
In vitro diagnostic use
Storage and handling conditions
Expiry date
Warnings and precautions
Content of the instructions for use
Manufacturer
Identification of the IVD reagent
Intended use
Principles of the examination method
Components
Additional required equipment
Reagent preparation
Storage and shelf life after first opening
Warnings and precautions
Primary sample collection, handling and storage
Examination procedure
Control procedure
Reading of examination results
Interpretation of results
Performance characteristics
General
Measuring interval
Biological reference intervals
Limitations of examination procedure
Literature references
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Related Information
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BS EN 13532:2002
General requirements for in vitro diagnostic medical devices for self-testing
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BS EN 13975:2003
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
Scope
Normative references
Terms and definitions
General
Essential requirements
Identification of kit components
Presentation of the instructions for use
Content of the outer container label
Manufacturer
Identification of the IVD reagent
IVD reagent name
Batch code
Contents
Intended use
In vitro diagnostic use
Storage and handling conditions
Expiry date
Warnings and precautions
Content of the immediate container label
General provisions
Single container
Small label
Manufacturer
Identification of the IVD reagent
IVD reagent or component name
Batch code
Contents
In vitro diagnostic use
Storage and handling conditions
Expiry date
Warnings and precautions
Content of the instructions for use
Manufacturer
Identification of the IVD reagent
Intended use
Principles of the examination method
Components
Additional required equipment
Reagent preparation
Storage and shelf life after first opening
Warnings and precautions
Primary sample collection, handling and storage
Examination procedure
Control procedure
Reading of examination results
Interpretation of results
Performance characteristics
General
Measuring interval
Biological reference intervals
Limitations of examination procedure
Literature references