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.

Description

A high-resolution leak tester designed for burst, creep, and leak tests, offering quick and accurate leak testing for various packaging materials.

Applicable Standards
  • 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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