Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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054
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Date of Entry 07/06/2020
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FR Recognition Number
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5-128
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Standard | |
ISTA 3E 2017 Similar Packaged-Products in Unitized Loads of Truckload Shipment |
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Scope/AbstractProcedure 3E covers the testing of unitized loads, made up of either single or multiple products or packages of the similar products prepared for shipment via a Full Truckload (FTL) delivery system carrier. FTL is defined as motor carrier shipment, where an entire trailer-load is filled with unitized packaged-products, often of similar retail packaged-products, intended for one destination.
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
21 CFR Part 820 Quality System Regulation |
Subpart C - Design Controls, Section 820.30(g) Design validation |
Subpart O - Statistical Techniques, Section 820.250 Statistical techniques |
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Relevant FDA Guidance and/or Supportive Publications*
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
ISO/TS 16775 First edition 2014-05-15 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |