ASTM D4169 09 PDF

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. 2. TITLE OF DATA ITEM. VALIDATION REPORT. 3. SUBTITLE. 4. AUTHORITY ( Data Acquisition Document No.) ASTM D 5. CONTRACT REFERENCE.

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The Distribution Cycle DC most commonly used for medical device packages is DC which is designed for the small parcel and overnight shipping mode. For use as a performance test, this practice requires that the shipping unit tested remain unopened until the sequence of tests are completed.

ASTM-D4169

This may, however, prohibit evaluating the influence of the container closure on container performance. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

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. For use as a performance test, this practice requires that the shipping unit tested remain unopened until the sequence of tests are completed. If known, container impact surfaces should be the same as occur in actual shipment. Customized distribution cycles can be designed when the anticipated distribution of the product is well understood and defined.

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ASTM D is the standard that has been used extensively in the medical device industry, as it is an FDA recognized consensus standard. What does this mean for medical device manufacturers? 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.

ASTM D – 16 Standard Practice for Performance Testing of Shipping Containers and Systems

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

Learn more about the different testing services provided at each location. This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution cycles.

This practice is not intended to supplant material specifications or existing preshipment test procedures. For more information visit www. 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. Schedule Asrm — 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 values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

ASTM-D – Medical Package Testing

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.

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It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Eight additional references were added. This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution cycles.

Annother Distribution Cycle that is sometimes used when air transport will not be used in the distribution enviroment is DC3, and it shown below.

Link to Active This link will asm route to the current Active version of the standard. Work Item s – proposed revisions of this standard. This may, however, prohibit evaluating the influence of the container closure on container performance.

Revisions to ASTM D4169 and Impact on Medical Device Package Testing

The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. D Terminology of Packaging and Distribution Environments. ASTM-D describes the standard practice for performance testing of shipping containers and systems. The tests should be performed sequentially on the same containers in the order given. 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.

This practice is not intended to supplant material specifications or existing preshipment test procedures.