Medical device manufacturers are subjected to a number of tests to obtain approval on each medical device package. According to the ISO 11607 standard, the manufacturer must ensure that the product and the packaging system form a complete product in the hands of the user that performs efficiently, safely and effectively.
The Validation Test is vital to ensure the integrity of the package. Verification shall guarantee and ensure that a package is properly sealed, sealed and protected from any number of external contaminants. Accelerated aging should take place after determining the integrity and packaging of the product.

If the sealant is not verified from a laboratory, the medical device manufacturer cannot market its products. The packets may also lose their integrity as a result of various events that occur during processing and / or delivery. The Package Verification Test can be used to verify that package integrity is maintained during processing, expected shelf life, and processing.

The integrity of the terminal sterilized medical device package is crucial to maintaining the sterility of the devices. For example, among a variety of other tests, a bubble emission test or paint penetration test can be used to test the integrity of the packaging seals of the medical packaging. EUROLAB's quality process includes validating these test methods according to ISO 11607 before testing your products. These requirements have been met to ensure that medical device packaging systems remain sterile and provide physical protection to the medical device up to the point of use.

EUROLAB Laboratory performs validation testing and is experienced in the application of approved test methods for testing in accordance with ISO 11607. EUROLAB can customize these test methods to include your preferred examination method. These may include variations for different materials and test methods specific to your packaging and specific requirements.
These tests can be carried out as ASTM D4169 transport simulation tests, ASTM F1980 simulated aging tests or as separate independent activities. Please contact EUROLAB for shipping simulation testing, packaging inspection testing, or other package testing you may require.

Tests generally include, but are not limited to:
ASTM F1886
Visual Inspection Test
ASTM F88
Peel Strength Test
ASTM F1140
Explosion Test
ASTM F1929
Dye Leakage Test
ASTM F1140
Creep Test
ASTM F2096
Bubble Emission Test
TS EN ISO 11607-2
Packaging of medical devices - Finally sterilized - section 2: Validation requirements for forming, sealing and joining processes
This standard covers the development and validation of processes for packaging medical devices to be sterilized.
TS EN 868-10
Packaging materials and systems for medical devices to be sterilized - Part 10: Adhesive coated nonwoven polyolefin materials for the manufacture of heat-sealable bags, reels and closures - Rules and test methods
TS EN 868-8
Packaging materials for finally sterilized medical devices - Part 8: Reusable sterilization containers for steam sterilizers in accordance with most 285 - Specifications and test methods
TS EN 868-10
Packaging for medical devices for final sterilization - Part 10: Adhesive coated nonwoven polyolefin materials - Requirements and test methods
TS EN 868-2
Packaging for medical devices for final sterilization - Part 2: Sterilization windings - Requirements and test methods
TS EN 868-6
Packaging for final sterilization of medical devices - Part 6: Paper for low temperature sterilization - Requirements and test methods
TS EN 868-3
Packaging materials and systems - for medical devices to be sterilized - Part 3: Paper bags (EN 868-4) and paper and roll (EN 868-5) production - Specifications and test methods
TS EN 868-7
Packaging materials and systems - for medical devices to be sterilized - Part 7: Adhesive coated paper for low temperature sterilization process - Specifications and test methods
TS EN 868-5
Packaging materials and systems - For medical devices to be sterilized - Part 5: Bags and rolls of heat and self-resealable paper and plastic film - Specifications and test methods
TS 10404 EN 868-1 (Former number: TS 10404 EN 868-1)
Packaging materials and systems for medical devices to be sterilized section 1: General specifications and test methods