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Medical Device Packaging Validations

Medical Device Packaging Validations

Medical device packaging validations demonstrate the strength, integrity and microbial barrier properties for porous and non-porous packages over time. These validations are required by FDA/ISO regulations before products can be sold. Nelson Laboratories offers ISO 11607 package validations for terminally sterilized medical devices.


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Applicable Standards

  • ISO 11607

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
PKG610 Packaging Validation (Non-Porous): Preparation, Protocol & Report Add
PKG620 Packaging Validation (Porous): Preparation, Protocol & Report Add
PKG630 Packaging Validation (Header Bag): Preparation, Protocol & Report Add
PKG610 - Packaging Validation (Non-Porous): Preparation, Protocol & Report
Standard TAT not available for this product
PKG620 - Packaging Validation (Porous): Preparation, Protocol & Report
Standard TAT not available for this product
PKG630 - Packaging Validation (Header Bag): Preparation, Protocol & Report
Standard TAT not available for this product

Study Outline

A packaging validation includes the following tests: ISO 11607 Part 1 requirements for materials, sterile barrier systems and packaging systems indicate that manufacturers choose one test from each category. Please see our Packaging Validation matrix or call us directly for more information.