Surgical instruments — Terms, measuring methods and test methods — Part 2: Methods for determination of basic measures

This document defines measuring methods for the determination of basic measurements of surgical standard instruments. This document does not apply to instruments for use on the central nervous system and on the central cardiovascular system. NOTE 1 Instruments for use on the central nervous system and on the central cardiovascular system are measured differently due to complex geometries which are adapted to the human anatomy. NOTE 2 In Annex A provides tables for converting customary units.

Instruments chirurgicaux — Termes, méthodes de mesurage et méthodes d'essai — Partie 2: Méthodes pour la détermination des mesures de base

General Information

Status
Not Published
Current Stage
5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
Start Date
17-Mar-2026
Completion Date
17-Mar-2026

Overview

ISO/FDIS 7554-2: Surgical instruments - Terms, measuring methods and test methods - Part 2: Methods for determination of basic measures is an international draft standard developed by ISO/TC 170. This standard specifies consistent and precise measuring methods for the determination of basic measurements of surgical standard instruments, ensuring accuracy, interoperability, and quality control within the medical device industry. ISO/FDIS 7554-2 is applicable to most surgical instruments, but specifically excludes those intended for the central nervous and central cardiovascular systems due to their unique anatomical and design requirements.

Key Topics

  • Standardized Measuring Methods
    ISO/FDIS 7554-2 outlines clear, standardized methods for measuring the basic dimensions of surgical instruments, promoting consistency in product specification and quality assessment.

  • Scope and Limitations
    The standard applies to a broad range of surgical standard instruments, but explicitly excludes instruments for the central nervous system and central cardiovascular system, as these require different measurement approaches due to complex geometries.

  • Measurement Fundamentals
    Key parameters defined include:

    • Overall Length: Measured in parallel to the reference axis, commonly when the instrument is fully closed or locked.
    • Joint Width and Thickness: Measured with respect to the instrument's design (e.g., parallel to the joint or rivet).
    • Jaw Width: Measured at a specific distance from the tip, typically 3 mm.
    • Penetration Depth: Relevant for retractors, valves, and hooks, measured from the inner surface.
  • Unit Conversion Guidance
    Annex A offers comprehensive conversion tables between customary units (Charrière/French gauge, millimeter, inch, and gauge) for standard instrument types such as catheters, probes, and cannulas.

Applications

ISO/FDIS 7554-2 provides practical value across several sectors:

  • Medical Device Manufacturers:
    Essential for product design, manufacturing, and quality control of surgical instruments, enabling producers to verify conformity to international measurement standards.

  • Regulatory Compliance:
    Supports compliance with national and international regulations for surgical instrument dimensions, improving patient safety and product reliability.

  • Procurement and Supply Chain:
    Assists healthcare providers, distributors, and procurement professionals in specifying and sourcing surgical instruments with transparent, comparable measurements.

  • Calibration and Inspection Services:
    Facilitates standardized methods for calibration, inspection, and verification in clinical engineering and quality assurance labs.

  • Education and Training:
    Provides a reference framework for training medical professionals and students in the proper identification and usage of surgical instruments by standardized dimensions.

Related Standards

For comprehensive understanding and implementation, consider the following related standards:

  • ISO/DIS 7554-1: Surgical instruments - Terms, measuring methods and tests - Part 1: Vocabulary. Provides essential terminology and definitions referenced in ISO/FDIS 7554-2.

  • ISO 7153 Series: Surgical instruments - Materials and general requirements. Covers material selection and manufacturing requirements for surgical instruments.

  • Other ISO and IEC Standards:

    • ISO 13485: Quality management systems for medical devices.
    • IEC 60601 Series: Safety standards for medical electrical equipment.

By adhering to ISO/FDIS 7554-2, manufacturers, regulators, and users of surgical instruments can ensure globally-recognized precision, interoperability, and quality in the measurement of surgical standard instruments, promoting both patient safety and operational efficiency.

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Frequently Asked Questions

ISO/FDIS 7554-2 is a draft published by the International Organization for Standardization (ISO). Its full title is "Surgical instruments — Terms, measuring methods and test methods — Part 2: Methods for determination of basic measures". This standard covers: This document defines measuring methods for the determination of basic measurements of surgical standard instruments. This document does not apply to instruments for use on the central nervous system and on the central cardiovascular system. NOTE 1 Instruments for use on the central nervous system and on the central cardiovascular system are measured differently due to complex geometries which are adapted to the human anatomy. NOTE 2 In Annex A provides tables for converting customary units.

This document defines measuring methods for the determination of basic measurements of surgical standard instruments. This document does not apply to instruments for use on the central nervous system and on the central cardiovascular system. NOTE 1 Instruments for use on the central nervous system and on the central cardiovascular system are measured differently due to complex geometries which are adapted to the human anatomy. NOTE 2 In Annex A provides tables for converting customary units.

ISO/FDIS 7554-2 is classified under the following ICS (International Classification for Standards) categories: 11.040.30 - Surgical instruments and materials. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO/FDIS 7554-2 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


DRAFT
International
Standard
ISO/DIS 7554-2
ISO/TC 170
Surgical instruments — Terms,
Secretariat: DIN
measuring methods and tests —
Voting begins on:
Part 2: 2025-01-24
Measuring methods for the
Voting terminates on:
2025-04-18
determination of basic measures of
surgical standard instruments
ICS: 11.040.30
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
This document is circulated as received from the committee secretariat.
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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 SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 7554-2:2025(en)
DRAFT
ISO/DIS 7554-2:2025(en)
International
Standard
ISO/DIS 7554-2
ISO/TC 170
Surgical instruments — Terms,
Secretariat: DIN
measuring methods and tests —
Voting begins on:
Part 2:
Measuring methods for the
Voting terminates on:
determination of basic measures of
surgical standard instruments
ICS: 11.040.30
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
This document is circulated as received from the committee secretariat. BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 7554-2:2025(en)
ii
ISO/DIS 7554-2:2025(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Measuring methods . 1
4.1 Fundamentals for measurement of lengths .1
4.2 Rules and exceptions .2
4.2.1 Length .2
4.2.2 Joint width .2
4.2.3 Joint thickness .2
4.2.4 Jaw width .3
4.2.5 Penetration depth .3
Annex A (informative) Tools for converting customary units . 6

iii
ISO/DIS 7554-2:2025(en)
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
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 expression
...


FINAL DRAFT
International
Standard
ISO/TC 170
Surgical instruments — Terms,
Secretariat: DIN
measuring methods and test
Voting begins on:
methods —
2026-03-17
Part 2:
Voting terminates on:
2026-05-12
Methods for determination of basic
measures
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 — Terms,
Secretariat: DIN
measuring methods and test
Voting begins on:
methods —
Part 2:
Voting terminates on:
Methods for determination of basic
measures
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 2026
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
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Measuring methods . 1
4.1 Fundamentals for measurement of lengths .1
4.2 Rules and exceptions .2
4.2.1 Length .2
4.2.2 Joint width .3
4.2.3 Joint thickness .3
4.2.4 Jaw width .4
4.2.5 Penetration depth .4
Annex A (informative) Tools for converting customary units . 5
Bibliography . 7

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 B
...


Date: 2025-08-04
ISO/TC 170
Secretariat: DIN
Date: 2026-02-12
Surgical instruments — — Terms, measuring methods and test
methods — —
Part 2:
Methods for determination of basic measures
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
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/DISFDIS 7554-2:20252026(en)
Contents
Foreword . iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Measuring methods . 1
4.1 Fundamentals for measurement of lengths . 1
4.2 Rules and exceptions . 2
Annex A (informative) Tools for converting customary units . 8
Bibliography . 11

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 7554 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
DRAFT International Standard ISO/DIS 7554-2:2025(en)

Surgical instruments — Terms, measuring methods and test methods
— —
Part 2:
Methods for determination of basic measures
1 Scope
This document specifies methods for the determination of basic measurements of surgical standard
instruments. This document does not apply to instruments for use on the central nervous system and on the
central cardiovascular system.
NOTE Instruments for use on the central nervous system and on the central cardiovascular system are measured
differently due to complex geometries which are adapted to the human anatomy.
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.
1)
ISO/DIS 7554--1, Surgical instruments — Terms, measuring methods and tests — Part 1: Vocabulary
3 Terms and definitions
1)
For the purposes of this document, the terms and definitions given in ISO /DIS 7554-11 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/
4 Measuring methods
4.1 Fundamentals for measu
...

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