The importance and standard development of medical equipment availability testing

Publisher: Administrator Date:2022-05-30

Jobs said: The core of the design is not the feeling and the feeling of touching, but the feeling of using it. So, how can consumers prove that a product is safe and easy to use before consumers have not tried it in person? The availability test is a reliable method for ensuring the comprehensive quality of the products such as the development, design, iterative update, and compliance listing of the product.


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Why is the availability test that has become an indispensable and important part of product production at all stages of product production

 

Before talking about the concept of "availability test\\ The so -called availability refers to whether the user can use the product correctly and efficiently whether it can use the product and achieve its functions, how efficiency, how the subjective feelings, etc. In fact, the product quality is actually the quality of the product. It can be said that availability is an important quality indicator of interactive products or systems and the core of product competitiveness.

 

Since it is "looking at product quality from the perspective of users\\

 

Let users with typical representatives operate the products after receiving training, and at the same time observers and recorders observe, interview, listen, and record. The test product can be a software app, a medical device, or any other product; it can be a designed early subsistence -guaranteed model or the final product that has been listed.

 

The availability test first appeared in the field of software development in the 1980s. After the software test, the designer improved the program based on user feedback. After nearly 40 years of development, the availability test has become an indispensable and important part of product design development and iterative maintenance. Its applications have also involved in many fields such as aerospace, nuclear industry, medical equipment, military equipment, and civil consumption. Essence

 

In the past 20 years, how has the availability standards in the field of medical devices develop?

 

In the field of medical devices, the IEC 62366-1 standard has clearly defined the "availability test\\ method. The purpose is to effectively identify the hazards and risks related to the use of the use of product interaction interface to meet the user needs of safe use and improve the user experience.

 

In 2007, the International Electricity Commission released IEC 62366 "The Application of Medical Device-Available Engineering in Medical Devices\\

 

In 2015, IEC 62366 was released. At the same time, the previous version was also equipped with a technical report IEC TR 62366-2 to help users implement availability engineering. The method of corresponding and availability engineering also described more detailed descriptions.

 

Today, the standard has been updated to the IEC 62366-1 2020 version. The requirements for product availability have gradually improved, and at the same time, the IEC62366 standard in the European Union and other regions has become the standard for the medical device market access. This means availability Tests will gradually develop from necessary links to necessary links.

 

Starting from availability testing, more secure and effective products have come out

 

From a business perspective, the availability test can improve the effectiveness, use efficiency of the product, and the satisfaction of the user's product. Its intervention can help enterprises better locate user characteristics, timely discover the user's use needs and pain points, so that the product is more to make the product more Close to the user's usage habits and increase product user stickiness. All these will help users' stable growth, create brand effects, and bring more commercial income to enterprises.

 

On the other hand, availability tests can discover the potential harm related to the use of products, control risks, make the product compliance and more secure and effective. Especially in the field of medical device, a potential risk of use may cause patients to be harmed or even lost life. Therefore, the role of medical device availability testing is very important.

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