Lot or Batch definition for IVDs


Quite Involved in Discussions
[FONT=&quot]US Regulation (21 CFR Part 820 (m))[/FONT][FONT=&quot][/FONT]
Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that is manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.[FONT=&quot][/FONT]
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EU Regulation[FONT=&quot][/FONT]
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[FONT=&quot]MEDDEV 2.5/6 Rev.1 February 1998[/FONT][FONT=&quot][/FONT]
[FONT=&quot]"Homogeneity of production batches“[/FONT][FONT=&quot] [/FONT]
[FONT=&quot]Certain statistical verification procedures are only meaningful when batches, (lots), are[/FONT]
[FONT=&quot]A batch is considered homogeneous when equivalent parts or materials are manufactured and/or tested in the same manner, without interruption, typically on the same day or in the same time period, and produced by the same person, or with the same machine/equipment set-up and fulfill the same specifications.[/FONT]
[FONT=&quot]For IVD's and certain other medical devices, such as dental material the following complementary definition shall apply: Mixtures of substances such as reagents aliquoted from the same bulk mixture are considered homogeneous if the mixing and aliquoted processes are validated.[/FONT]
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[FONT=&quot]Note: In ISO 2859, „lot“ is defined similar to "homogeneous batch“ of this paper.[/FONT][FONT=&quot][/FONT]
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[FONT=&quot]”batch (lot): a defined amount of material, either starting material, intermediate or finished product, which is uniform in its properties and has been produced in one process or series of processes.” [/FONT][FONT=&quot][/FONT]