This document specifies general requirements for staplers, including requirements for stapler classification, intended performance, design attributes, design evaluation, manufacturing, sterilization, packaging, information supplied by the manufacturer, and tests to demonstrate conformance with these requirements.
This document is applicable to single-use staplers and reusable staplers.
This document only applies to instruments that use staples.
BSI recommends this version of standard for organisations operating in or with the UK. The ISO edition is available here if required.