ISO/FDIS 6335-2
(Main)Surgical instruments — Staplers — Part 2: General requirements
Surgical instruments — Staplers — Part 2: General requirements
This document defines common terms for stapler in terms of its components and use, and elaborates their specific meanings. This document applies to staplers and their components. This document does not apply to special vascular stapler, cardiac valve stapler, circumcision stapler, purse-string suture device, or other staplers to which this standard does not apply due to different working principle or for other reasons.
Instruments chirurgicaux — Agrafeuses — Partie 2: Exigences générales
General Information
Standards Content (Sample)
FINAL DRAFT
International
Standard
ISO/TC 170
Surgical instruments — Staplers —
Secretariat: DIN
Part 2:
Voting begins on:
2025-11-20
General requirements
Voting terminates on:
2026-01-15
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 170
Surgical instruments — Staplers —
Secretariat: DIN
Part 2:
Voting begins on:
General requirements
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
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 .5
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
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
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)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
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
FINAL DRAFT International Standard ISO/FDIS 6335-2:2025(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
1)
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
1) Under preparation. Stage at the time of drafting: ISO/FDIS 6335-1.
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-crit
...
ISO/TC 170
Secretariat: DIN
Date: 2025-09-0311-06
Surgical instruments — Staplers —
Part 2:
General requirements
FDIS stage
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents
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 . 3
7 Materials . 3
8 Design evaluation . 4
8.1 General . 4
8.2 Pre-clinical evaluation . 4
8.3 Clinical evaluation . 4
8.4 Post-market surveillance . 5
9 Manufacture . 5
10 Sterilization . 5
10.1 General . 5
10.2 Products supplied sterile . 5
10.3 Sterilization by the user . 5
11 Packaging . 6
11.1 Protection from damage in storage and transportation . 6
11.2 Maintenance of sterility in transit . 6
12 Information supplied by the manufacturer . 6
12.1 General . 6
12.2 Labelling . 6
12.3 Instructions for use . 7
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
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely 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)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO'sISO’s adherence to the World Trade
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 in this field and
reducing the risks of stapler products.
v
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 complianceconformance with these
requirements.
This document is applicable to single-use staplers and reusable staplers.
This document only applies to instruments, which uses 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 — ALL PARTS — Part 2: Unalloyed titanium
1 1)
ISO 6335-1, Surgical instruments — Staplers — Part 1: Terms and definitions Vocabulary
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
ISO 8601-1, Date and time — Representations for information exchange — Part 1: Basic rules
ISO 10993-1, Biological evaluation of medical devices —Part 1: Evaluation and testing — 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 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
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
Under preparation. Stage at the time of drafting: ISO/FDIS 6335-1.
1)
Under preparation. Stage at the time of drafting: ISO/FDIS 6335-1.
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 17665-1, Sterilization of health care products — Moist heat —Part 1: — 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 /FDIS 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 and minimally invasive surgery, when
the stapler is used clinically
4 Classification
The stapler can be classified according to the following attributes:
— the numberNumber of uses: single-use stapler or reusable stapler.
— functionsFunctions: cutter stapler or non-cutter stapler.
— useUse modes (surgical modes): open stapler or endoscopic stapler.
— layoutsLayouts of staples: linear stapler or circular stapler.
— driveDrive modes: manual stapler or powered stapler.
Manufacturers may make classifications according to actual attributes of the stapler.
5 Intended performance
The intended performance of the stapler shall be described and documented by addressing the following, with
regard to safety:
a) intended purpose;
b) intended applicable tissues;
c) intended surgical modes.
6 Desi
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