Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)

ISO 14607:2018 specifies particular requirements for mammary implants.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.

Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO 14607:2018, korrigierte Fassung 2018-08)

Dieses Dokument legt besondere Anforderungen an Mammaimplantate fest.
Im Hinblick auf die Sicherheit legt dieses Dokument Anforderungen an die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designbewertung, Herstellung, Verpackung, Sterilisation und vom Hersteller zu liefernde Informationen fest.

Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières (ISO 14607:2018, Version corrigée 2018-08)

L'ISO 14607:2018 spécifie les exigences particulières relatives aux implants mammaires.
En matière de sécurité, le présent document spécifie des exigences relatives aux performances prévues, aux caractéristiques de conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à l'emballage, à la stérilisation et aux informations fournies par le fabricant.

Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO 14607:2018, popravljena verzija 2018-08)

Ta dokument določa posebne zahteve za prsne vsadke.
V zvezi z varnostjo ta standard določa zahteve za predvideno zmogljivost, obliko, materiale, vrednotenje oblike, izdelavo, pakiranje, sterilizacijo in informacije, ki jih zagotovi proizvajalec.

General Information

Status
Published
Publication Date
15-May-2018
Withdrawal Date
29-Nov-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-May-2018
Completion Date
16-May-2018

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14607:2018
01-julij-2018
1DGRPHãþD
SIST EN ISO 14607:2009
Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO
14607:2018)
Non-active surgical implants - Mammary implants - Particular requirements (ISO
14607:2018)
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen
(ISO 14607:2018)
Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières (ISO
14607:2018)
Ta slovenski standard je istoveten z: EN ISO 14607:2018
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 14607:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 14607:2018

---------------------- Page: 2 ----------------------

SIST EN ISO 14607:2018


EN ISO 14607
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2018
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 14607:2009
English Version

Non-active surgical implants - Mammary implants -
Particular requirements (ISO 14607:2018)
Implants chirurgicaux non actifs - Implants Nichtaktive chirurgische Implantate -
mammaires - Exigences particulières (ISO Mammaimplantate - Besondere Anforderungen (ISO
14607:2018) 14607:2018)
This European Standard was approved by CEN on 26 February 2018.

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, 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14607:2018 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 14607:2018
EN ISO 14607:2018 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

2

---------------------- Page: 4 ----------------------

SIST EN ISO 14607:2018
EN ISO 14607:2018 (E)
European foreword
This document (EN ISO 14607:2018) 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 November 2018, and conflicting national standards
shall be withdrawn at the latest by November 2018.
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 14607:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
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, Serbia, Slovakia, Slovenia, Spain, Swede
...

SLOVENSKI STANDARD
SIST EN ISO 14607:2018
01-julij-2018
Nadomešča:
SIST EN ISO 14607:2009
Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO
14607:2018, popravljena verzija 2018-08)
Non-active surgical implants - Mammary implants - Particular requirements (ISO
14607:2018, Corrected version 2018-08)
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen
(ISO 14607:2018, korrigierte Fassung 2018-08)
Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières (ISO
14607:2018, Version corrigée 2018-08)
Ta slovenski standard je istoveten z: EN ISO 14607:2018
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 14607:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 14607:2018

---------------------- Page: 2 ----------------------
SIST EN ISO 14607:2018


EN ISO 14607
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2018
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 14607:2009
English Version

Non-active surgical implants - Mammary implants -
Particular requirements (ISO 14607:2018, Corrected
version 2018-08)
Implants chirurgicaux non actifs - Implants Nichtaktive chirurgische Implantate -
mammaires - Exigences particulières (ISO Mammaimplantate - Besondere Anforderungen (ISO
14607:2018) 14607:2018)
This European Standard was approved by CEN on 26 February 2018.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 12 December 2018.

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
C OMITÉ EUROPÉEN DE NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14607:2018 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 14607:2018
EN ISO 14607:2018 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

2

---------------------- Page: 4 ----------------------
SIST EN ISO 14607:2018
EN ISO 14607:2018 (E)
European foreword
This document (EN ISO 14607:2018) 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 November 2018, and conflicting national standards
shall be withdrawn at the latest by November 2018.
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 14607:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
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 Repu
...

SLOVENSKI STANDARD
oSIST prEN ISO 14607:2017
01-junij-2017
Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO/DIS
14607:2017)
Non-active surgical implants - Mammary implants - Particular requirements (ISO/DIS
14607:2017)
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen
(ISO/DIS 14607:2017)
Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières
(ISO/DIS 14607:2017)
Ta slovenski standard je istoveten z: prEN ISO 14607
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14607:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 14607:2017

---------------------- Page: 2 ----------------------
oSIST prEN ISO 14607:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14607
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:
2017-04-17 2017-07-09
Non-active surgical implants — Mammary implants —
Particular requirements
Implants chirurgicaux non actifs — Implants mammaires — Exigences particulières
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT 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
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14607:2017(E)
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. ISO 2017

---------------------- Page: 3 ----------------------
oSIST prEN ISO 14607:2017
ISO/DIS 14607:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 14607:2017
ISO/DIS 14607:2017(E)
Contents Page
Foreword . vi
1 Scope. 1
2 Normative references . 1
3 Terms and definitions . 1
4 Intended performance . 3
5 Design attributes. 3
6 Materials . 3
6.1 General . 3
6.2 Cytotoxicity. 4
6.3 Residual low molecular weight oligomers . 4
6.4 Trace elements. 4
6.5 Physico - Mechanical properties and characterization. 4
7 Design evaluation .
...

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