ISO Testing

TEN-E performs ISO package testing under ANAB ISO/IEC 17025 accreditation, the international standard for laboratory competence. Our confirmed ISO scope covers sterile barrier system validation to ISO 11607 and conditioning to ISO 2233.

What ISO Testing Covers

ISO (International Organization for Standardization) publishes the product and packaging standards recognized across international regulatory and quality frameworks. ISO packaging standards define material requirements, conditioning protocols, test procedures, and performance criteria that manufacturers, regulators, and healthcare systems accept globally. TEN-E performs testing to three confirmed ISO standards, detailed below, covering sterile barrier validation and conditioning.

A note on ISO/IEC 17025: the standard governs laboratory competence, covering testing procedures, equipment calibration, and quality management systems. ISO/IEC 17025 is the accreditation TEN-E holds through ANAB, and it is the credential that gives our test results documented standing with regulators, retailers, and certification programs. ISO/IEC 17025 is a laboratory framework, and TEN-E performs testing to ISO product standards under that accreditation.

ISO Standards

Select a standard to expand its details, including what it covers, what it measures, and how TEN-E tests to it.

ISO 11607 Packaging for Terminally Sterilized Medical Devices ISO 11607 sets the requirements for sterile barrier systems that keep terminally sterilized medical devices sterile through distribution and shelf life.

Issuing Body ISO

Applies To Sterile barrier systems, medical device packaging

Test Type Sterile barrier validation

Overview

ISO 11607 defines requirements for materials, sterile barrier systems, and packaging systems used with terminally sterilized medical devices. The standard spans two parts: Part 1 covers materials and design, and Part 2 covers validation of the forming, sealing, and assembly processes. Validation confirms the packaging maintains sterility from production through the product’s intended distribution environment and shelf life. ISO 11607 is referenced in FDA requirements for medical device packaging and accepted by international regulatory bodies.

Key Parameters

Material Qualification Sterile barrier materials are qualified against the standard's requirements for microbial barrier, strength, and compatibility with the sterilization method.
Design Validation: Testing verifies sterile barrier integrity through seal strength, seal-defect detection, and package integrity methods.

Process Validation (Part 2) The forming, sealing, and assembly processes are validated to produce a consistent sterile barrier.

Stability and Aging Real-time and accelerated aging support the packaging's claimed shelf life.

Design Validation Testing verifies sterile barrier integrity through seal strength, seal-defect detection, and package integrity methods.

Documentation typically covers the packaging system validated, the materials and processes qualified, each integrity and aging test performed, and pass or fail findings against ISO 11607 requirements.

ISO 2233 Conditioning for Testing ISO 2233 sets the temperature and humidity conditions used to condition packaging before performance testing.

Issuing Body ISO

Applies To Filled transport packages and unit loads

Test Type Pre-test conditioning

Overview

ISO 2233 specifies standard atmospheres of temperature and relative humidity for conditioning complete, filled transport packages and unit loads before testing. Conditioning brings samples to a documented, consistent moisture content and temperature so performance results reflect a known starting state. Medical device, pharmaceutical, environmental, and distribution programs incorporate ISO 2233 conditioning ahead of subsequent tests.

Key Parameters

Standard Atmospheres The standard defines temperature and relative humidity combinations selected to represent the intended climate.

Conditioning Duration Samples are held in the selected atmosphere long enough to reach equilibrium before testing.

Application Conditioning runs ahead of drop, vibration, compression, and other performance tests.

Documentation typically covers the atmosphere selected, the conditioning duration, and confirmation that samples reached the specified condition before performance testing.

Not Sure Where to Start?

Let our experts help you identify the ISO standards that fit your product and regulatory requirements.

Frequently Asked Questions

ISO/IEC 17025 is a laboratory competence standard. It governs how a laboratory operates: its procedures, equipment calibration, personnel qualifications, and quality management system. Accreditation to ISO/IEC 17025 through ANAB means an independent body has assessed and confirmed that TEN-E’s lab meets those requirements. ISO 11607, ISO 2233, and ISO 21898 are product and process standards that define what packaging must do and how it is tested. TEN-E performs testing to those product standards, and the results carry documented credibility because the lab holds ISO/IEC 17025 accreditation.

ISO 2233 specifies the temperature and humidity conditions for conditioning packaging and packaging materials before performance testing. Pre-test conditioning establishes baseline material properties and moisture content so that test results reflect how packaging performs under consistent, documented starting conditions. Conditioning protocols under ISO 2233 are incorporated into many medical device, pharmaceutical, environmental, and distribution testing programs. TEN-E performs ISO 2233 conditioning in the same accredited lab environment as subsequent performance testing, maintaining sample integrity throughout the full test program.