SIST EN ISO 7153-1:2017

Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016)

ISO 7153-1:2016 specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry.
While ISO 7153-1:2016 is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.

Chirurgische Instrumente - Werkstoffe - Teil 1: Metalle (ISO 7153-1:2016)

Instruments chirurgicaux - Matériaux - Partie 1: Métaux (ISO 7153-1:2016)

ISO 7153-1:2016 spécifie les métaux couramment utilisés pour la fabrication de différents types d'instruments chirurgicaux normalisés, incluant, sans toutefois s'y limiter, ceux employés en chirurgie générale, en chirurgie orthopédique et en médecine bucco-dentaire.
Bien que l'ISO 7153-1:2016 ne soit pas destiné aux instruments chirurgicaux utilisés dans des applications particulières, telles que l'implantologie et la chirurgie mini-invasive, des parties de ce document pourraient s'y appliquer.

Kirurški instrumenti - Materiali - 1. del: Kovine (ISO 7153-1:2016)

Ta del standarda ISO 7153 določa kovine, ki se običajno uporabljajo za izdelavo različnih vrst standardnih kirurških instrumentov, kar brez omejitev vključuje instrumente za uporabo na področju splošne kirurgije, ortopedije in zobozdravstva.
Ta del standarda ISO 7153 sicer ni namenjen za kirurške instrumente za posebno uporabo, na primer implantologijo in minimalno invazivne kirurške posege, vendar se lahko deloma uporablja za takšne instrumente.
OPOMBA: pri izbiranju razreda jekla ter oblike, dimenzije in dobavnih pogojev surovine za proizvodnjo kirurških instrumentov je treba upoštevati dejavnike, kot je zasnova instrumenta ali proizvajalčevi proizvodni obrati, kar ni zajeto v tem delu standarda ISO 7153.
Zato ni predvideno niti možno, da bi lahko bila na podlagi informacij v tem delu standarda ISO 7153 proizvajalcu instrumenta odvzeta odgovornost odločanja glede izbire ustrezne surovine s primernimi lastnostmi. Prav tako ni predvidena izključitev uporabe drugih vrst jekla (npr. ogljikovega jekla za rezalne instrumente) v proizvodnji instrumentov. To odločitev je mogoče sprejeti v skladu z objavljenimi mednarodnimi standardi za kirurške instrumente, saj lahko vsebujejo dodatne ali nove informacije, ki jih je treba upoštevati pri izbiri ustreznih razredov jekla.

General Information

• Status: Published
• Public Enquiry End Date: 29-Sep-2015
• Publication Date: 04-Dec-2016
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 77.140.20 - Stainless steels
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 02-Nov-2016
• Due Date: 07-Jan-2017
• Completion Date: 05-Dec-2016
• Ref Project: EN ISO 7153-1:2016 - Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016)

Relations

• Replaces: SIST EN ISO 7153-1:2001 - Surgical instruments - Metallic materials - Part 1: Stainless steel (ISO 7153-1:1991, including Amendment 1:1999)
• Effective Date: 01-Jan-2017

Overview

EN ISO 7153-1:2016 - Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016) is the CEN-adopted ISO standard that lists metals commonly used for manufacturing standard surgical instruments (general surgery, orthopaedics, dentistry). Published October 2016 (third edition), it supersedes earlier editions and provides harmonized guidance for material selection across European and international markets. The standard is informational for manufacturers and does not remove the responsibility of the instrument designer or producer to choose the final raw material and delivery condition.

Key topics

• Material categories covered: stainless steels (martensitic, austenitic, precipitation-hardening), hard metals (carbide-based), and titanium grades/alloys (including Ti‑6Al‑4V references).
• Fields of application: tables mapping material reference letters/grades to typical instrument types and components (forceps, scissors, needle holders, implants excluded in general scope).
• Mechanical and metallurgical data: hardness values given in Rockwell (HRC) and Vickers (HV) where available to aid specification and quality control.
• Normative references: linked test and material standards such as EN 10088-1 (stainless steel list), ISO 6507/6508 (Vickers/Rockwell hardness tests), and ISO 5832 series for surgical implant titanium.
• Scope limits and manufacturer responsibilities: explicitly states the standard is not intended for special applications (e.g., implantology, minimally invasive devices), though parts may apply; manufacturers must consider instrument design and production when selecting grades.

Applications

• Material selection for medical device manufacturing: choose appropriate stainless steel, titanium, or hard metal grade for blades, handles, shafts, and wear surfaces.
• Specification and procurement: inform purchase specifications and supplier contracts with accepted grades and hardness ranges.
• Quality control and testing: use referenced hardness test methods and material designations for acceptance criteria and batch verification.
• Design guidance: align component selection (e.g., martensitic steels for cutting tools, austenitic for corrosion resistance) with intended use and sterilization environments.

Who uses this standard

• Surgical instrument manufacturers and OEMs
• Biomedical engineers and product designers
• Procurement and supplier quality teams
• Notified bodies, conformity assessors, and testing laboratories
• Standards committees and regulatory affairs professionals

Related standards

• ISO 5832 series (metallic materials for implants)
• EN 10088-1 (stainless steels list)
• ISO 6507 / ISO 6508 (Vickers and Rockwell hardness test methods)
• Relevant ASTM specifications for titanium (as referenced)

Using EN ISO 7153-1:2016 helps ensure consistent, traceable material choices in surgical instrument production, improving performance, safety, and regulatory alignment.

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2017
1DGRPHãþD
SIST EN ISO 7153-1:2001
Kirurški instrumenti - Materiali - 1. del: Kovine (ISO 7153-1:2016)
Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016)
Chirurgische Instrumente - Werkstoffe - Teil 1: Metalle (ISO 7153-1:2016)
Instruments chirurgicaux - Matériaux - Partie 1: Métaux (ISO 7153-1:2016)
Ta slovenski standard je istoveten z: EN ISO 7153-1:2016
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
77.140.20 Visokokakovostna jekla Stainless steels
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 7153-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2016
EUROPÄISCHE NORM
ICS 11.040.30; 77.140.20 Supersedes EN ISO 7153-1:2000
English Version
Surgical instruments - Materials - Part 1: Metals (ISO
7153-1:2016)
Instruments chirurgicaux - Matériaux - Partie 1: Chirurgische Instrumente - Werkstoffe - Teil 1: Metalle
Métaux (ISO 7153-1:2016) (ISO 7153-1:2016)
This European Standard was approved by CEN on 10 September 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7153-1:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 7153-1:2016) has been prepared by Technical Committee ISO/TC 170 “Surgical
instruments” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2017, and conflicting national standards shall be
withdrawn at the latest by April 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 7153-1:2000.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 7153-1:2016 has been approved by CEN as EN ISO 7153-1:2016 without any
modification.
INTERNATIONAL ISO
STANDARD 7153-1
Third edition
2016-10-01
Surgical instruments — Materials —
Part 1:
Metals
Instruments chirurgicaux — Matériaux —
Partie 1: Métaux
Reference number
ISO 7153-1:2016(E)
©
ISO 2016
ISO 7153-1:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
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ii © ISO 2016 – All rights reserved

ISO 7153-1:2016(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Fields of application of materials . 1
4 Materials . 8
Annex A (informative) Examples of dental instruments .11
Bibliography .13
ISO 7153-1:2016(E)
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 on 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 the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 170, Surgical instruments.
This third edition cancels and replaces the second edition (ISO 7153-1:1991), which has been extended
from stainless steels to metals and has been technically revised.
It also incorporates the Amendment ISO 7153-1:1991/Amd 1:1999.
ISO 7153 consists of the following parts, under the general title Surgical instruments — Materials:
— Part 1: Metals
iv © ISO 2016 – All rights reserved

INTERNATIONAL STANDARD ISO 7153-1:2016(E)
Surgical instruments — Materials —
Part 1:
Metals
1 Scope
This part of ISO 7153 specifies metals commonly used to manufacture various types of standard
surgical instruments, including but not limited to those used in general surgery, orthopaedics and
dentistry.
While this part of ISO 7153 is not intended for surgical instruments used in special applications, such
as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.
NOTE When selecting the grade of steel and the shape, dimensions and delivery conditions of the raw
material for manufacturing surgical instruments, it is necessary to take into account factors, such as the design
of the instrument or the production facilities of the manufacturer, that are not covered by this part of ISO 7153.
For this reason, it is not intended, nor is it possible, for the information given in this part of ISO 7153 to remove
the decision-making responsibility from the instrument manufacturer for selecting an appropriate raw product
with suitable properties; nor is it intended to preclude the use of other types of steel in the manufacture of
instruments, such as the use of carbon steel for cutting instruments. International Standards for surgical
instruments, when published, can be observed when making this decision as they may contain additional or new
information to be taken into account when selecting appropriate steel grades.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 5832-3, Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium
4-vanadium alloy
ISO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 6508-1, Metallic materials — Rockwell hardness test — Part 1: Test method
EN 10088-1, Stainless steels — Part 1: List of stainless steels
ASTM B 265, Standard Specification for Titanium and Titanium Alloy Strip, Sheet, and Plate
ASTM B 348, Standard Specification for Titanium and Titanium Alloy Bars and Billets
3 Fields of application of materials
Since there are different requirements to various surgical instruments, there also have to be different
requirements to the materials from which the instruments are manufactured. For this reason, not all
of the materials listed within Clause 4 are suited to use in every type of instrument. For most types
of surgical instruments, materials are given in Tables 1 to 3 which are known from experience to be
suitable for those instruments. Although it might be possible that other materials are also suited to the
manufacture of some types of instruments, this is not covered by this part of ISO 7153.
ISO 7153-1:2016(E)
Table 1 indicates which stainless steels are commonly used to manufacture various types of standard
instruments and instrument components. In the first column, a reference letter is given pointing to the
stainless steels specified within Table 4. In addition, the second column gives the respective referen
...