Lot

How a lot is defined decides how far a nonconformity or recall reaches. A tight lot definition limits the scope of a field action.

defined amount of material or a number of medical devices, including finished product and accessories (3.1), that is manufactured in one process or a series of related processes and is intended to be homogenous Note 1 to entry: A lot or batch is manufactured under essentially the same conditions and is intended to have uniform characteristics and quality within specified limits. A lot or batch is considered homogeneous when equivalent parts or materials are manufactured 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 fulfil the same quality specification. Note 2 to entry: The defined amount of material or number of medical devices or accessories is normally associated with a unique statement of conformity to a defined quality specification.

ISO 20417:2021, clause 3.14