
TME BT Integra Pack: Smart Package Tester
The TME BT Integra Pack: Smart Package Tester complies with the following standards and certifications: - ASTM F-2054: Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization and Restraining Plates - ASTM F-1140: Standard Test Method for Internal Pressurization (Burst) Testing of Flexible Packaging - ASTM F-2095: Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization Bubble Test - ISO 11607: Packaging for Terminally Sterilized Medical Devices - FDA CFR 21 Part 11: Electronic Records; Electronic Signatures These standards and certifications ensure the device's compliance with industry requirements for package testing.
A high-resolution leak tester designed for burst, creep, and leak tests, offering quick and accurate leak testing for various packaging materials.
ANSI/AAMI/ISO 11607-1
Amendment 1 to ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging
ASTM F2096
Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM F1140
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
ASTM F2095
Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
ASTM F2054/F2054M
Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
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