ISO 6335-2:2026

Surgical instruments — Staplers Part 2: General requirements (Edition 1, 2026)

Abstract

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.

General information