COMMERCIAL ITEM DESCRIPTION A-A-51978
Table II. Sampling for tests.
|
Characteristic |
Inspection level |
AQL (% defective) |
|
USP Class IV |
S-1 |
* |
|
Leakage |
S-2 |
* |
|
Sterility |
See sterility clauses above |
* |
* Acceptable number shall be zero for all sample sizes.
Instructions. Instructions for use shall be present with the container for the catheter and needle unit of issue.
Workmanship. The catheter and needle unit shall be free from defects which detract from its appearance or impair its serviceability.
Unit of issue. Package (PG). One package containing 50 individually packaged catheter and needle units, as specified constitutes one unit (of issue). The individual catheter and needle unit shall be contained in a rigid tray or container having a sealed, peel-open type lid. A sealed pouch of high density polyethylene (4 mil minimum) is also acceptable. The package for the individual catheter and needle unit shall be capable of maintaining sterility of contents unless it is damaged or opened. The package shall also provide mechanical protection against handling and transportation exigencies that may cause damage or kinking of the catheter and needle unit.
Quality Assurance Provisions.
Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwise specified in the contact or purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.
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