Among the oldest package integrity tests. • Referred to as “non-simulation” test. • Not item-by-item comparable with ASTM. • ASTM D Distribution Cycle 2. ASTM-D describes the standard practice for performance testing of shipping containers and systems. It provides a guide for the evaluation of shipping units. 10 May Details on one of the most widely used distribution simulation test methods, ASTM D – Standard Practice for Performance Testing of.
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It provides a astm d4169 09 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. The Distribution Cycle DC most 90 used for medical device packages is DC which is designed for the small parcel astm d4169 09 overnight shipping mode. Referenced Documents purchase separately The documents listed below 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 astm d4169 09 standard. 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 – 16 Standard Practice for Performance Testing of Shipping Containers and Systems
Customized distribution cycles can be designed when the anticipated astm d4169 09 of the product is well understood and defined. Work Item s – proposed revisions of this standard.
This practice is not intended to supplant material astm d4169 09 or existing preshipment astm d4169 09 d416. For use as a performance test, this practice requires that the shipping unit tested remain unopened until the sequence of tests are completed. Link to Active This link will always route to the current Active version of the standard. This practice is not intended to supplant material specifications or existing preshipment test procedures. Learn more about the different testing services provided at each location.
The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. If used for astm d4169 09 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 health practices and determine the applicability of regulatory limitations prior to use.
D Terminology of Packaging and Distribution Environments. Eight d4619 references were added.
ASTM D is the test method performed by astm d4169 09 shipping units to a test plan consisting of a sequence of hazard elements which would aastm encountered in various distribution environments.
The tests should be performed astm d4169 09 on the same containers in the order given. For more information visit www. Historical Version s – view previous versions of standard.
Annother Distribution Cycle that is astm d4169 09 used when air transport will not be used in the distribution enviroment is DC3, and it shown below. 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 d4169 09 D is the standard that has been used extensively in the medical f4169 industry, as it is an FDA recognized consensus standard.
Revisions to ASTM D and Impact on Medical Device Package Testing
ASTM-D describes the standard practice for performance testing of shipping containers and systems. What does this mean for medical device manufacturers?
If known, container impact surfaces should be the same as astm d4169 09 in actual shipment. This is accomplished by subjecting them to a test plan consisting of a sequence v4169 anticipated hazard elements encountered in various distribution cycles.
This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various astm d4169 09 cycles.
This may, however, prohibit evaluating the influence of the container closure x4169 container performance. 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. This may, however, prohibit evaluating the influence of the container closure on container performance. If used for other purposes, such as astm d4169 09 development, it may be useful to open and inspect shipping units at various times throughout the sequence.