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ISO 6335-2:2026

Surgical instruments — Staplers — Part 2: General requirements ISO 6335-2:2026

Publication date:   Feb 5, 2026

General information

60.60   Standard published   Feb 5, 2026

ISO

ISO/TC 170 Surgical instruments

International Standard

11.040.30   Surgical instruments and materials

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Published

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Scope

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.

Life cycle

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PUBLISHED
ISO 6335-2:2026
60.60 Standard published
Feb 5, 2026




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