ISO Packaging Test: Types and Definitions

The International Organization for Standardization (ISO) is a global federation of national standards bodies, known as ISO member bodies. ISO packaging tests are designed to ensure that products and services are safe, reliable, and of high quality. For businesses, these standards serve as strategic tools that help reduce costs by minimizing waste and errors while boosting productivity. They also enable companies to enter new markets, create a level playing field for developing countries, and promote free and fair global trade.

History of ISO Packaging

The journey of ISO began in 1946 when delegates from 25 countries gathered at the Institute of Civil Engineers in London. They decided to establish a new international organization aimed at facilitating the international coordination and unification of industrial standards. Officially founded on February 23, 1947, ISO has since published over 22,104 International Standards covering nearly all aspects of technology and manufacturing. The organization comprises members from 168 countries and operates with the support of 779 technical committees and subcommittees dedicated to standard development.

ISO Packaging Standards:

ISO 11607:2006 - Packaging for Terminally Sterilized Medical Devices

Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems**

ISO 11607-1:2006 specifies the requirements for materials and test methods used in pre-formed sterile barrier systems, sterile barrier systems, and packaging systems intended to maintain the sterility of terminally sterilized medical devices until they are used.

Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes**

ISO 11607-2:2006 outlines the requirements for developing and validating processes involved in packaging medical devices that undergo terminal sterilization. These processes include forming, sealing, and assembling preformed sterile barrier systems, sterile barrier systems, and packaging systems.

ISO 11607:2006 is applicable across various industries including healthcare facilities where medical devices are placed in sterile barrier systems and sterilized. However, it does not cover all requirements for sterile barrier systems and packaging systems for aseptically manufactured medical devices. Additional requirements may be necessary for drug/device combinations.

ISO 2244:2000 (2016) - Horizontal Impact Tests

This standard specifies methods for horizontal impact testing on complete, filled transport packages or unit loads. The test can be performed as a single test to assess the effects of horizontal impact or as part of a sequence of tests designed to evaluate a package's ability to withstand distribution systems that include horizontal impact hazards.

Normative documents associated with this standard include:

- ISO 2206: Identification of parts when testing complete, filled transport packages.

- ISO 2233: Conditioning complete, filled transport packages and unit loads for testing.

ISO 12048:1994 - Compression and Stacking Tests

This standard details methods for testing the resistance to compression of complete, filled transport packages using a compression tester. It also describes how to conduct stacking tests using the same apparatus. These tests can assess a package's performance in terms of strength or protection offered under compressive forces.

ISO 13820:2014 - Compression-Testing Equipment

This standard describes various types of equipment used for conducting compression tests on paper, board, and corrugated fibreboard. It distinguishes between two types of instruments:

1. Fixed-Platen Compression Tester:** Develops compressive forces at a constant rate of strain.

2. Beam-Deflection Compression Tester:** Develops compressive forces between one platen driven at constant speed and another platen resting on a deformable beam.

While both instruments yield similar results in compression tests, they are not identical. The beam-deflection tester often produces higher results than the fixed-platen machine due to differences in loading rates and material characteristics being tested.

ISO 8318 (2000) details two methods for performing sinusoidal vibration tests: one on a fully packed transport package and the other on a unit load using variable frequency. These tests are crucial for evaluating the strength and protective capabilities of packaging when exposed to vertical vibrations. They can be conducted as standalone tests or integrated into a series of assessments designed to measure how well a package or unit load can withstand vibration hazards during distribution.

Key normative documents referenced in this standard include:

- ISO 2206: Packaging — Complete, filled transport packages — Identification of parts when testing.

- ISO 2233: Packaging — Complete, filled transport packages and unit loads — Conditioning for testing.

- ISO 2234: Packaging — Complete, filled transport packages and unit loads — Stacking tests using static load.

ISO 13355:2016 specifies a method for conducting vertical random vibration tests on complete, filled transport packages and unit loads using random excitation. This standard also outlines ways to assess the performance of packaging in terms of its strength or the protection it offers when subjected to vertical vibrations. These tests can be performed individually or as part of a sequence to evaluate the ability of a test specimen to endure distribution systems that include vibration hazards.

ISO 17025:2017 sets general requirements for the competence of testing and calibration laboratories. It aims to promote confidence in laboratory operations by ensuring they can produce valid results. Laboratories adhering to this standard will generally operate in line with ISO 9001 principles. The document requires laboratories to plan and implement actions addressing risks and opportunities, thereby enhancing management system effectiveness and preventing negative outcomes. Compliance with this standard facilitates cooperation between laboratories globally, aiding in information exchange, experience sharing, and harmonization of standards and procedures.

ISO 2247:2000 describes methods for conducting vibration tests on complete, filled transport packages or unit loads using sinusoidal excitation at fixed low frequencies. These tests assess the performance of packaging in terms of strength or protection against low-frequency vibrations. They can be performed as single tests or part of a sequence designed to evaluate how well packaging withstands low-frequency vibration hazards or repetitive shocks.

ISO 2248:1985 specifies a method for performing vertical impact tests on complete, filled transport packages by dropping them. This test can be done individually to investigate vertical impact effects or as part of a series measuring the package's ability to endure distribution systems that include vertical impact hazards.

At Safe Load Testing Technologies, we assist companies in performing necessary packaging tests to optimize costs and comply with relevant standards through our advanced transport simulation equipment. With two decades of experience in the shipping simulation industry, we provide precise solutions that closely mimic real-world conditions.

In summary, these ISO standards provide comprehensive guidelines for ensuring that packaging meets stringent safety and quality criteria across various industries.