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Standards Development
This document defines common terms for stapler in terms of its components and use, and elaborates their specific meanings. This document applies to staplers and their components. This document does not apply to special vascular stapler, cardiac valve stapler, circumcision stapler, purse-string suture device, or other staplers to which this standard does not apply due to different working principle or for other reasons.
"Staplers" products have been widely used in clinical surgery for more than 30 years. With the rapid development of clinical technology and manufacturing technology, at present, there have been nearly 10 kinds of stapler products with different uses and structural , and used in more types of clinical surgery. Staplers has become a worldwide medical devices, there are a large number of stapler trades in the international market every year. According to Market and Market, the global Market for surgical staplers was $3.38 billion in 2017 and $4.78 billion in 2022, CAGR is 7.2%. With the wide use of staplers, product risks are gradually increasing. FDA announced that from January 1, 2011 to March 31, 2018, staplers were involved in more than 32,000 malfunctions, more than 9,000 serious injuries, and 366 deaths, and proposed to reclassify the surgical stapler as a highrisk medical device. In the European Union's medical device management, most staplers are defined as IIB, which always belongs to the product management category with a high risk. Formulate the staplers terms and definition standards is beneficial to the circulation of technology, products and parts in the industry; it is helpful to provide terminology basis for various innovative staplers in the future and make more scientific product classification; helpful for the reference and specification of the product structure and use index when formulating the industry standard of various kinds of special stapler products in the future; It is helpful to realize the standardization and consistency of communication between manufacturers and clinicians, between government agencies and enterprises, and between enterprises in the stapler industry, and greatly reduce the differences in understanding caused by the differences in descriptive terms.
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