ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). ISO packaging test ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade.

 

Brief history of ISO

 

The ISO story began in 1946 when delegates from 25 countries met at the Institute of Civil Engineers in London and decided to create a new international organization ‘to facilitate the international coordination and unification of industrial standards’. On 23 February 1947 the new organization, ISO, officially began operations. Since then, they have published over 22.104 International Standards covering almost all aspects of technology and manufacturing and they have members from 161 countries and 779 technical committees and subcommittees to take care of standards 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 is a standard that specifies the requirements for materials and test methods, pre-formed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

Part 2: Validation requirements for forming, sealing and assembly processes

ISO 11607-2:2006 describes the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

ISO 11607: 2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.

 

> ISO 2244:2000 (2016) Packaging – Complete, filled transport packages and unit loads – Horizontal impact tests

This International Standard specifies methods of horizontal impact testing (horizontal or inclined plane test and pendulum test) on a complete, filled transport package or a unit load. The test may be performed either as a single test to investigate the effects of horizontal impact or as part of a sequence of tests designed to measure the ability of a package or a unit load to withstand a distribution system that includes a horizontal impact hazard.

The following normative documents contain provisions which constitute provisions of this International Standard:

  • 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 12048:1994 Packaging – Complete, filled transport packages – Compression and stacking tests using a compression tester

This International Standard specifies a method for testing the resistance to compression of complete, filled transport packages and a method for carrying out a stacking test on complete, filled transport packages using the same apparatus.

The test may be used to assess the performance of a package in terms of its strength or the protection it offers to its contents when it is subjected to compressive forces. A test may be performed either as a single test to investigate the effects (deformation, collapse or failure) of compression or stacking, or as part of a sequence of tests designed to measure the ability of a package to withstand a distribution system that includes a compression or stacking hazard.

This test may also be used as a stacking test to investigate performance under particular conditions of loading, as, for example, when the bottom package in a stack rests on an open-decked pallet.

 

> ISO 13820:2014 Paper, board and corrugated fibreboard – Description and calibration of compression-testing equipment

This International Standard describes the types of testing equipment available for carrying out compression tests on paper, board, and corrugated fibreboard. It describes two distinct types of instrument:

-The fixed-platen compression tester, develops compressive forces at a constant rate of strain. This tester is preferred because of its better reliability, its ability to test over the range of test levels likely to be found, and because the characteristics of existing instruments have been well defined and universally accepted.

-The other, known as the beam-deflection compression tester, develops compressive forces between one platen driven at constant speed and another platen resting on a deformable beam. With this type neither rate of stress nor rate of strain is constant.

The two instrument types give similar but not necessarily the same test results when used for compression tests; literature shows that the beam deflection machine produces results higher than those of the fixed-platen machine. The extent of the difference depends on the test being conducted and on the characteristics, particularly the elastic characteristics, of the material being tested.

The beam-deflection tester has been inadequately defined in past International Standards for compression tests; among existing instruments there have been different loading rates, different beam stiffnesses, and therefore different rates of strain. Furthermore, in some countries, the stiffness of beams commonly available is such that no one beam is appropriate for all the test levels likely to be found, so that it has been common practice to use two beams of different stiffnesses interchangeably to cover the full range of loads.

 

> ISO 8318 (2000) Packaging – Complete, filled transport packages and unit loads – Sinusoidal vibration tests using a variable frequency

This International Standard specifies two methods for carrying out a sinusoidal vibration test on a complete, filled transport package or unit load using a variable frequency. These tests may be used to assess the performance of a package or a unit load in terms of its strength or the protection that it offers to its contents when it is subjected to vertical vibration. Each may be performed either as a single test to investigate the effects of vertical vibration or as part of a sequence of tests designed to measure the ability of a package or unit load to withstand a distribution system that includes a vibration hazard.

The following normative documents contain provisions which constitute provisions of this International Standard:

  • 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 Packaging – Complete, filled transport packages and unit loads – Vertical random vibration test

This International Standard specifies a method to carry out a vertical random vibration test on a complete, filled transport package(s) and unit loads using random excitation1. This document also provides methods for assessing the performance of a package in terms of its strength or the protection that it offers to its contents when it is subjected to vertical vibration. The test discussed in this document can be performed either as a single test to investigate the effects of vertical vibration, or as a part of a sequence of tests designed to measure the ability of a test specimen to withstand a distribution system that includes a vibration hazard.

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application:

  • 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 a static load

 

> ISO 17025:2017 General requirements for the competence of testing and calibration laboratories

This document has been developed with the objective of promoting confidence in the operation of laboratories. This document contains requirements for laboratories to enable them to demonstrate they operate competently, and are able to generate valid results. Laboratories that conform to this document will also operate generally in accordance with the principles of ISO 9001.

This document requires the laboratory to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, achieving improved results and preventing negative effects. The laboratory is responsible for deciding which risks and opportunities need to be addressed.

The use of this document will facilitate cooperation between laboratories and other bodies, and assist in the exchange of information and experience, and in the harmonization of standards and procedures. The acceptance of results between countries is facilitated if laboratories conform to this document.

 

> ISO 2247:2000 Packaging – Complete, filled transport packages and unit loads – Vibration tests at fixed low frequency

This International Standard specifies methods to carry out vibration tests on complete, filled transport packages or unit loads using sinusoidal excitation at fixed frequency. These tests may be used to assess the performance of packages and unit loads in terms of the strength or the protection that they offer to their contents when subjected to low frequency vibration.
These kind of tests may be performed either as a single test to investigate the effects of low frequency vibration or as a part of a sequence of tests designed to measure the ability of a package or unit load to withstand a distribution system that includes a vibration hazard at low frequency or repetitive shocks.

 

> ISO 2248:1985 Packaging – Complete, filled transport packages – Vertical impact test by dropping

This International Standard specifies a method for carrying out a vertical impact test on a complete, filled transport package by dropping. It may be performed either as a single test to investigate the effects of vertical impact or as part of a sequence of tests designed to measure the ability of a package to withstand a distribution system that includes a vertical impact hazard.