EN ISO 16061:2021

Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment.
NOTE     In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen (ISO 16061:2021)

Dieses Dokument legt die allgemeinen Anforderungen für Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden, fest. Diese Anforderungen gelten für Instrumente während ihrer Herstellung und wenn sie nach Aufarbeitung geliefert werden.
ANMERKUNG   Sofern nicht anders angegeben bezeichnet der Begriff „Instrument“ in diesem Dokument ein Instrument, das in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet wird.
Dieses Dokument ist auch für Instrumente anzuwenden, die mit Antriebseinheiten verbunden werden können, aber es gilt nicht für die Antriebseinheiten selbst.
In Bezug auf die Sicherheit legt dieses Dokument die Anforderungen für die vorgesehene Funktion, Konstruktionsmerkmale, Werkstoffe, Designbewertung, Herstellung, Sterilisation, Verpackung und durch den Instrumentenhersteller bereitgestellte Informationen, im Weiteren Hersteller genannt, fest.
Dieses Dokument ist nicht für Instrumente anzuwenden, die in Verbindung mit Dentalimplantaten, transendodontischen und transradikulären Implantaten sowie ophthalmologischen Implantaten verwendet werden.

Instruments à utiliser en association avec les implants chirurgicaux non actifs - Exigences générales (ISO 16061:2021)

Le présent document spécifie les exigences générales relatives aux instruments à utiliser en association avec les implants chirurgicaux non actifs. Ces exigences s'appliquent aux instruments fournis après fabrication ou aux instruments fournis après remise en état.
NOTE       Dans le présent document, sauf indication contraire, le terme «instrument» désigne un instrument destiné à être utilisé en association avec les implants chirurgicaux non actifs.
Le présent document s'applique également aux instruments pouvant être connectés à des systèmes motorisés, mais il ne s'applique pas aux systèmes eux-mêmes.
En matière de sécurité, le présent document donne les exigences relatives aux performances prévues, aux caractéristiques de conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant d'instruments, ci-après appelé fabricant.
Le présent document ne s'applique pas aux instruments associés aux implants dentaires, aux implants transendodontiques et transradiculaires, et aux implants ophtalmiques.

Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantatih) - Splošne zahteve (ISO 16061:2021)

General Information

• Status: Published
• Publication Date: 30-Mar-2021
• Withdrawal Date: 29-Sep-2021
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285 - Non-active surgical implants
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 31-Mar-2021
• Completion Date: 31-Mar-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 16061:2021 - Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)

Relations

• Replaces: EN ISO 16061:2015 - Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16061:2021
01-julij-2021
Nadomešča:
SIST EN ISO 16061:2015
Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantatih) -
Splošne zahteve (ISO 16061:2021)
Instruments for use in association with non-active surgical implants - General
requirements (ISO 16061:2021)
Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet
werden - Allgemeine Anforderungen (ISO 16061:2021)
Instruments à utiliser en association avec les implants chirurgicaux non actifs -
Exigences générales (ISO 16061:2021)
Ta slovenski standard je istoveten z: EN ISO 16061:2021
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN ISO 16061:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EN ISO 16061
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2021
EUROPÄISCHE NORM
ICS 11.040.40; 11.040.99 Supersedes EN ISO 16061:2015
English Version

Instruments for use in association with non-active surgical
implants - General requirements (ISO 16061:2021)
Instruments à utiliser en association avec les implants Instrumente, die in Verbindung mit nichtaktiven
chirurgicaux non actifs - Exigences générales (ISO chirurgischen Implantaten verwendet werden -
16061:2021) Allgemeine Anforderungen (ISO 16061:2021)
This European Standard was approved by CEN on 5 January 2021.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16061:2021 E
worldwide for CEN national Members.

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SIST EN ISO 16061:2021
EN ISO 16061:2021 (E)
Contents Page
European foreword . 3

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SIST EN ISO 16061:2021
EN ISO 16061:2021 (E)
European foreword
This document (EN ISO 16061:2021) has been prepared by Technical Committee ISO/TC 150 "Implants
for surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” 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 September 2021, and conflicting national standards
shall be withdrawn at the latest by September 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 16061:2015.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 16061:2021 has been approved by CEN as EN ISO 16061:2021 without any modification.

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INTERNAT
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