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Product Safety Assessment

Olympus has established various quality assurance mechanisms based on international certification systems. These allow us to assess product quality accurately, ensure that customers can use our products with confidence, and achieve continuing improvement.

Ensuring Product Safety through Quality Evaluation at the Development Stage

Olympus is consistently applies the customer's perspective to its manufacturing and service activities. Quality evaluation at the development stage, which is the starting point for manufacturing, is especially important to the achievement of product quality. Various product evaluation methods are available, including electromagnetic compatibility (EMC) testing, safety testing, environmental testing and materials analysis.

Calibration

Calibration is a process used to maintain the accuracy of measuring instruments by ensuring that all components are functioning correctly. The precision of measuring instruments can vary from day to day in response to changes in environmental conditions. As an entity certified under the Japan Calibration Service System and the Measurement Law, Olympus carefully monitors errors caused by these changes and applies approved calibration methods to its measuring equipment.

Using three-dimensional measurement equipment

Using three-dimensional measurement equipment

EMC and Safety Testing

A 10 m wave anechoic chamber built by Olympus in 2004 is one of the most advanced facilities of its type in the world. It has been certified for use in electromagnetic noise systems under the National Voluntary Laboratory Accreditation Program (NVLAP) of the United States and the Telefication organization of the Netherlands. It was also the first safety testing facility for electrical medical devices in Japan to be certified by the Japan Accreditation Board for Conformity Assessment (JAB) under ISO/IEC 17025:2005*1, which is the international standard for the certification of testing facilities.

Olympus added another 10 m wave anechoic chamber in 2009, creating a testing system that complies with the latest standard for electro-medical devices (IEC 60601-1, 3rd Edition and supplementary rules). In addition to the continuing development of its facilities and systems, Olympus also maintains an active training program for assessment technicians, and several Olympus employees have become qualified as EMC iNARTE*2 technicians.

As a testing laboratory accredited under the internationally recognized ILAC-MRA system, this facility also conducts compliance evaluations for medical equipment under the IEC60601-1 standard.

*1 ISO/IEC17025 (2005): General requirements for the competence of testing and calibration laboratories
*2 EMC: Electro-Magnetic Compatibility iNARTE: The International Association for Radio, Telecommunications and Electromagnetics

EMC testing in a 10 m wave anechoic chamber

EMC testing in a 10 m wave anechoic chamber

Mechanical and Environmental Testing

Mechanical testing is used to evaluate product strength and life by assessing the impact of usage and storage conditions on quality, and by checking the effects of vibration and dropping during packaging, transportation, delivery and other processes. Environmental testing is carried out using a variety of systems and equipment. The aim is to assess products under the environmental conditions in which they are likely to be used by customers.

Packaging undergoes a dropping test.

Packaging undergoes a dropping test.

Materials Analysis

In addition to the analysis and evaluation of parts and materials at the development stage, Olympus also uses various analytical systems to identify defects and other issues through detailed analyses carried out after products have been brought to market. Findings from these analyses are used to eliminate the causes of problems and prevent recurrences.

Olympus will continue to improve the safety of its products by enhancing the reliability of its evaluation systems.

Materials analytical laboratory

Materials analytical laboratory

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