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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If used for other purposes, such as package development, it may be useful to open and inspect f4169-09 units at various d4169-009 throughout the d416-09. ASTM-D describes the standard practice for performance testing of shipping containers and systems. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution cycles.
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. For use as a performance test, this practice requires that the shipping unit tested remain unopened until the sequence of tests are completed.
Referenced F4169-09 purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. The Distribution Cycle DC most commonly used for medical device packages is DC which is designed for the small parcel and overnight shipping mode.
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. It is the responsibility of the user of this standard to establish appropriate safety and d41699-09 practices and determine the d419-09 of regulatory limitations prior to use. The tests should be performed sequentially on the same containers in the order given.
For use as a performance test, this practice requires that the shipping unit tested remain unopened until the sequence of tests are completed. What does this mean for medical device manufacturers? Schedule H — Environmental hazard Slight changes were made to the water temperature during spray sessions of ambient conditioning sstm Assurance Level I. 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.
Eight additional references were added.
ASTM D – 09 Standard Practice for Performance Testing of Shipping Containers and Systems
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.
zstm For more information visit www. If known, container impact surfaces should be the same as occur in actual shipment. This practice is not intended to supplant material specifications or existing preshipment test procedures. D Terminology of Packaging and Distribution Environments.
Revisions to ASTM D4169 and Impact on Medical Device Package Testing
Learn more about the different testing services provided at each location. This may, however, prohibit evaluating the influence of the container closure on container performance.
This practice is not intended to supplant material specifications or existing preshipment test procedures. Link to Active This link will always route to the current Active version of the standard. Annother Distribution Cycle that is sometimes used when air transport will not be used in the distribution enviroment wstm DC3, and it shown below.
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.
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. Schedule G — Rail switching Four impacts instead of three shall now d4169-099 performed Assurance Level I shall be used for open-top rail car load tests.
ASTM D is the standard that has been used extensively in the medical device industry, as it is an FDA recognized consensus standard. Historical Version s – view previous versions of standard. Work Item s – proposed revisions of this standard.