ISO/PWI 6335-2

Surgical instruments — Staplers — Part 2: General requirements

Scope

This document specifies general requirements for staplers, including requirements for stapler classification, intended performance, design attributes, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
This document is applicable to single-use stapler and reusable stapler.
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 principles or for other reasons.