ISO 6335-2:2026

Current Revision
Surgical instruments - Staplers - Part 2: General requirements

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ISO 6335-2:2026

Surgical instruments - Staplers - Part 2: General requirements

ISO 6335-2:2026

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.

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