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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What does this mean for medical device manufacturers? This may, however, prohibit evaluating the influence of the container closure on container performance.

Customized distribution cycles can be designed when the anticipated distribution of the product is well understood and defined. This practice is not intended to supplant material specifications d4169-0 existing preshipment test procedures. Referenced Documents purchase separately The documents listed below are referenced within the subject standard 4d169-09 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. For more information visit www.

ASTM D – 09 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 units at various times throughout the sequence.

Annother Distribution Cycle that is sometimes used when air transport will not be used in the distribution enviroment is DC3, and it shown below. This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution cycles. 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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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. This practice is not intended to supplant material specifications or existing preshipment test procedures.

Revisions to ASTM D4169 and Impact on Medical Device Package Testing

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

Historical Version s – view previous versions of standard. Eight additional references were added.

ASTM-D – Medical Package Testing

Learn more about the different testing services provided at each location. 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. Schedule H — Environmental hazard Slight changes were made to the water temperature during spray sessions of ambient conditioning during Assurance Level I.

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-D describes the standard practice for performance testing of shipping containers and systems. For use as a performance test, this practice requires that the shipping unit tested remain unopened until the sequence of tests are completed. Work Item s – proposed revisions of this standard.

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This may, however, prohibit evaluating the influence of the container closure on container performance. ASTM D is the standard that has been used extensively in the medical device industry, as it is an FDA recognized consensus standard.

Link to Active This link will always route to the current Active version of the standard. If known, container impact surfaces should be the same as occur in actual shipment.

ASTM D is the test method performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements aztm would be encountered in various distribution environments. D Terminology of Packaging and Distribution Environments.

The tests should be performed sequentially on the same containers in the order given. 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. 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 asmt, this practice requires that the shipping unit tested remain unopened until the sequence of tests are completed.