ASTM D4169-09 PDF

2. TITLE OF DATA ITEM. VALIDATION REPORT. 3. SUBTITLE. 4. AUTHORITY ( Data Acquisition Document No.) ASTM D 5. CONTRACT REFERENCE. Review of Protective Package Testing Protocols, pre-ASTM D; Overview and Significance , 15, 18, 20, 10, 3, same, Mod to DC 18, other edit changes. Among the oldest package integrity tests. • Referred to as “non-simulation” test. • Not item-by-item comparable with ASTM. • ASTM D Distribution Cycle 2.

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ASTM-D – Medical Package Testing

The Distribution D41169-09 DC most commonly used for medical device packages is DC which is designed for the small parcel and overnight shipping mode. D Terminology of Packaging and Distribution Environments.

This may, however, prohibit evaluating the influence of the container closure on container d4169–09. This practice is not intended to supplant material specifications or existing preshipment test procedures. It provides a guide for the evaluation of shipping units in accordance with a uniform system, using established test methods at levels representative of those occurring in actual distribution.

If used for other purposes, such as package development, it may be useful to open and inspect sstm units at various times throughout the sequence. For use as a performance test, this practice requires that the shipping unit tested remain unopened until the sequence of tests are completed.

ASTM D is the standard that has d41690-9 used extensively in the medical device industry, as it is an FDA recognized consensus standard. Learn more about the different testing services provided at each location. ASTM D is the test method performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements which would be encountered in various distribution environments.

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This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution cycles.

What does this mean for medical device manufacturers? If known, container impact surfaces should be the same as occur in actual shipment. If the shipping orientation is not known, or if more than one orientation is possible, the first three impacts should be on that test specimen surface which is deemed to be most sensitive to damage. Customized distribution cycles can be designed when the anticipated distribution of the product is well understood and defined.

This may, however, prohibit evaluating the influence of the container closure on container performance. For more information visit www. Annother Distribution Cycle that is sometimes used when air transport will not be used in the distribution enviroment is DC3, and it shown below.

For use as a performance test, this practice requires that the shipping unit tested remain unopened until the sequence of tests are completed.

ASTM-D describes the standard practice for performance testing of shipping containers and systems. This practice is not intended to supplant material specifications or existing preshipment test procedures.

Referenced Documents purchase separately The documents listed d169-09 are referenced within the subject standard but are not provided as part of the standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

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This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution cycles.

It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations ast, to use.

If used for other purposes, such as package development, it may be useful to open and inspect shipping units at various times throughout the sequence.

ASTM-D4169

The values given in parentheses are mathematical conversions to SI units that are provided for information only and are e4169-09 considered standard. Eight additional references were added. Work Item s – proposed revisions of this standard.

Link to Active This link will always route to the astn Active version of the standard. Schedule G — Rail switching Four impacts instead of three shall now be performed Assurance Level I shall be used for open-top rail car load tests. Schedule H — Environmental hazard Slight changes were made to the water temperature during spray sessions of ambient conditioning during Assurance Level I.

Historical Version s – view previous versions of standard. The tests should be performed sequentially on the same containers in the order given.