ISO 6335-2:2026

International
Standard
ISO 6335-2
First edition
Surgical instruments — Staplers —
2026-02
Part 2:
General requirements
Instruments chirurgicaux — Agrafeuses —
Partie 2: Exigences générales
Reference number
© ISO 2026
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 2
5 Intended performance . 2
6 Design attributes . 2
7 Materials . 3
8 Design evaluation . 3
8.1 General .3
8.2 Pre-clinical evaluation . .3
8.3 Clinical evaluation .4
8.4 Post-market surveillance .4
9 Manufacture . 4
10 Sterilization . 4
10.1 General .4
10.2 Products supplied sterile .4
10.3 Sterilization by the user .5
10.3.1 Products supplied non-sterile .5
10.3.2 Re-sterilization .5
10.3.3 Sterilization residues.5
11 Packaging. 5
11.1 Protection from damage in storage and transportation .5
11.2 Maintenance of sterility in transit .5
12 Information supplied by the manufacturer . 6
12.1 General .6
12.2 Labelling .6
12.3 Instructions for use .6
12.4 Restrictions on combinations .7
12.5 Marking for special purposes .7
Bibliography . 8

iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
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rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
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this may not represent the latest information, which may be obtained from the patent database available at
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Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 170, Surgical instruments.
A list of all parts in the ISO 6335 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
Introduction
This document covers general requirements for stapler design, evaluation, sterilization and packaging.
This document is aimed at improving the standardization of stapler design and production and reducing the
risks of stapler products.
v
International Standard ISO 6335-2:2026(en)
Surgical instruments — Staplers —
Part 2:
General requirements
1 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 5832-2, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium
ISO 6335-1, Surgical instruments — Staplers — Part 1: Vocabulary
ISO 8601-1, Date and time — Representations for information exchange — Part 1: Basic rules
ISO 10993-1, Biological evaluation of medical devices — Part 1: Requirements and general principles for the
evaluation of biological safety within a risk management process
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of
development, validation and routine control
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 17664-1, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

ISO 17665, Sterilization of health care products — Moist heat — Requirements for the development, validation
and routine control of a sterilization process for medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 6335-1 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
surgical mode
common operations adopted by the physician, including open surgery an
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