Vibration and Shock Test Requirement for ISO 20072

ISO 20072 is an important standard applicable for Medical and Pharmaceutical industries. It is international standard that provides requirements and test methods for Aerosol Drug Delivery Device (ADDD) design verification. This international standard applies to hand-held single- and multi-use ADDDs intended to deliver a metered or pre-metered aerosolized medication to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites). This International Standard applies to both refillable and disposable devices intended for personal use.

ISO 20072 Standard tests_ETS.JPG
 

According to ISO 20072 clause 6.2.7, the ADDDs need to be subjected to:

  1. Vibration Test according to IEC 60068-2-64

  2. Shock Test according to IEC 60068-2-27

ISO 20072 Standard tests_ETS_1.png
 

These tests are needed to simulate the transport of the ADDD by the operator during normal travel with any caps and/or specified or supplied protective carrying cases (ISO 20072: Annex C).

In order to be able to perform Vibration and Shock Tests according to IEC 60068, following items are needed:

  1. Vibration Shaker which can be used for Sine and Random Test up to 2000 Hz, and also 100 G Shock Test, with good uniformity and minimum cross axial movement.

  2. Vibration Controller which can perform Resonance Search, Random, and Shock Test.

  3. Well-designed fixture, with good transmissibility.

ISO 20072 Standard tests_ETS1.JPG

ETS SHAKER SERIES with IPA Amplifier technology is designed to meet the requirement of various vibration and shock test standards. The Vibration Controller software has also been developed to ensure the testing accuracy.

Vibration testing fixture is a very important component which determine the accuracy of vibration testing. To help customers optimize their product designs and address tough engineering challenges, we offer complete Vibration Testing Fixture design process, including finite element analysis, fabrication, test and data correlation.

ETS is a one stop solution provider for Vibration and Shock Testing requirements from products to ISO17025 accredited testing services.