---
kind: "section"
citation: "21 C.F.R. § 158.3"
title: "21"
number: "158.3"
heading: "Definitions."
url: "https://uscodex.org/cfr/21/158.3"
---

# §158.3. Definitions.


For the purposes of this part the following definitions shall apply:

- (a) **Lot.** A collection of primary containers or units of the same size, type and style manufactured or packed under similar conditions and handled as a single unit of trade.
- (b) **Lot size.** The number of primary containers or units (pounds when in bulk) in the lot.
- (c) **Sample size.** The total number of sample units drawn for examination from a lot.
- (d) **Sample unit.** A container, a portion of the contents of a container, or a composite mixture of product from small containers that is sufficient for the examination or testing as a single unit.
- (e) **Defective.** Any sample unit shall be regarded as defective when the sample unit does not meet the criteria set forth in the standards.
- (f) **Acceptance number.** The maximum number of defective sample units permitted in the sample in order to consider the lot as meeting the specified requirements. The following acceptance numbers shall apply:
- (g) **Acceptable quality level—** (AQL). The maximum percent of defective sample units permitted in a lot that will be accepted approximately 95 percent of the time.

## Notes

### Amendments

[42 FR 14461, Mar. 15, 1977]

### Authority

Authority: 21 U.S.C. 321, 341, 343, 348, 371.

### Amendments

[42 FR 14461, Mar. 15, 1977]