Standard: HHS - 21 CFR PART 158


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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:

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 158
Publish Date: 2017-04-01
Page Count: 4
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 158 Change Type: COMPLETE REVISION Update Date: 2014-04-01 Status: ACTV
21 CFR PART 158 Change Type: COMPLETE REVISION Update Date: 2015-04-01 Status: ACTV
21 CFR PART 158 Change Type: COMPLETE REVISION Update Date: 2016-04-01 Status: ACTV

Standards That Reference This Standard

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