ISO 6335-2:2026

Surgical instruments — Staplers — Part 2: General requirements

OVERVIEW

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.

COMMENTS

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PRODUCT DETAILS

Status Current
Edition 2026
No. of Pages 8
ICS Classification 11.040.30 Surgical instruments and materials
Committee ISO/TC 170
Available for Purchase For sale in Singapore only
Adoption ISO : 0