SIST EN ISO 14607:2025

SLOVENSKI STANDARD
01-oktober-2025
Nadomešča:
SIST EN ISO 14607:2018
Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO
14607:2024)
Non-active surgical implants - Mammary implants - Specific requirements (ISO
14607:2024)
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen
(ISO 14607:2024)
Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières (ISO
14607:2024)
Ta slovenski standard je istoveten z: EN ISO 14607:2025
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 14607
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 14607:2018
English Version
Non-active surgical implants - Mammary implants -
Specific requirements (ISO 14607:2024)
Implants chirurgicaux non actifs - Implants Nichtaktive chirurgische Implantate -
mammaires - Exigences particulières (ISO Mammaimplantate - Besondere Anforderungen (ISO
14607:2024) 14607:2024)
This European Standard was approved by CEN on 17 October 2024.

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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14607:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 4
European foreword
This document (EN ISO 14607:2025) 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 February 2026, and conflicting national standards
shall be withdrawn at the latest by February 2026.
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 14607:2018.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 14607:2024 has been approved by CEN as EN ISO 14607:2025 without any modification.

Annex ZA
(informative)
Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this harmonized standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the differences are indicated in the Annex Z. For the purpose of using this
standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in
this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this document
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region the standard can only
support European regulatory requirements to the extent of the scope of the European Regulation for
medical devices ((EU) 2017/745).
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those
relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Performance Clause(s) /
Requirements of subclause(s) of Remarks / Notes
Regulation (EU) this EN
2017/745
10.1(a) 6.3, 6.4.1 10.1(a) is covered with respect to the choice of
silicone gel materials based on their combined
residual oligomers, regarding toxicity by 6.3.
10.1(a) is covered with respect to the choice of raw
materials based on unintentional trace elements in
them, regarding toxicity by 6.4.1.
10.1(b) 7.2.1, 7.2.5 10.1(b) is covered with respect to the pre-clinical
biological evaluation of compatibility of the breast
implants with biological tissues by 7.2.1 and 7.2.5.
However, some parts of 7.2.1 and 7.2.5 contain
recommendations rather than requirements, which
limits their usefulness for the coverage of 10.1(b).
10.1(f) 7.2.2.1, Annex B 10.1(f) is covered with respect to shell integrity by
7.2.2.1 and Annex B.
7.2.2.2, Annex C 10.1(f) is covered with respect to implant resistance
by 7.2.2.2 and Annex C.
7.2.3.3.2, 10.1(f) is covered with respect to silicone gel
Annex E cohesion by 7.2.3.3.2 and Annex E.
10.1(g) 7.2.3.7, Annex G 10.1(g) is covered by 7.2.3.7 and Annex G.
10.1(h) Annex A 10.1(h) is covered with respect to the confirmation
that the raw silicone gel meets specifications
regarding combined residual oligomers by Annex A.
Annex B 10.1(h) is covered with respect to the confirmation
that implant meets specifications regarding shell
.
integrity by Annex B
Annex C 10.1(h) is covered with respect to the confirmation
that the implant meets specifications regarding
implant fatigue, impact resistance, and endurance
load level by Annex C.
Annex E 10.1(h) is covered with respect to the confirmation
that the silicone gel meets specifications regarding
silicone gel cohesion by Annex E.
Annex F 10.1(h) is covered with respect to the confirmation
that the silicone gel meets specifications regarding
.
silicone gel penetration by Annex F
Annex G 10.1(h) is covered with respect to the confirmation
that the silicone gel meets specifications regarding
General Safety and
Performance Clause(s) /
Requirements of subclause(s) of Remarks / Notes
Regulation (EU) this EN
2017/745
surface classification by Annex G.
23.1(g) Annex I e), 23.1(g) is covered with respect to information and
Annex I g)
warnings supplied by the manufacturer to patients
regarding residual risks, potential harm, and adverse
effects by Annex I e) and Annex I g).
Table ZA.2 — Normative references from clause 2 of this document and their corresponding
European publications
Reference in International Title Corresponding European
Clause 2 Standard Edition Standard Edition
ISO 34-1:2022 ISO 34-1:2022 Rubber, vulcanized or For applicable standard
thermoplastic — edition see Column 2
Determination of tear
strength — Part 1: Trouser,
angle and crescent test pieces
ISO 37:2017 ISO 37:2017 Rubber, vulcanized or For applicable standard
thermoplastic — edition see Column 2
Determination of tensile
stress-strain properties
ISO 48-4 ISO 48-4:2018 Rubber, vulcanized or For applicable standard
thermoplastic — edition see Column 2
Determination of hardness —
Part 4: Indentation hardness
by durometer method (Shore
hardness)
ISO 10993-1 ISO 10993-1:2018 Biological evaluation of EN ISO 10993-1:2020
medical devices — Part 1:
Evaluation and testing within
a risk management process
ISO 10993-5 ISO 10993-5:2009 Biological evaluation of EN ISO 10993-5:2009
medical devices — Part 5:
Tests for in vitro cytotoxicity
ISO 10993-6 ISO 10993-6:2016 Biological evaluation of EN ISO 10993-6:2016
medical devices — Part 6:
Tests for local effects after
implantation
ISO 10993-18 ISO 10993-18:2020 Biological evaluation of EN ISO 10993-
and medical devices — Part 18: 18:2020+A1:2023
ISO 10993- Chemical characterization of
18:2020/Amd 1:2022 medical device materials
within a risk management
process
Reference in International Title Corresponding European
Clause 2 Standard Edition Standard Edition
ISO/TS 10993- ISO/TS 10993-20: Biological evaluation of For applicable standard
20 2006 medical devices — Part 20: edition see Column 2
Principles and methods for
immunotoxicology testing of
medical devices
ISO 11607-1 ISO 11607-1:2019 Packaging for terminally EN ISO 11607-1:2020
sterilized medical devices —
Part 1: Requirements for
materials, sterile barrier
systems and packaging
systems
ISO 14155 ISO 14155:2020 Clinical investigation of EN ISO 14155:2020
medical devices for human
subjects — Good clinical
practice
ISO ISO 14630:2024 Non-active surgical implants EN ISO 14630:2024
14630:2024 — General requirements
ISO 14971 ISO 14971:2019 Medical devices — EN ISO 14971:2019 +
Application of risk A11:2021
management to medical
devices
ISO 20417 ISO 20417:2021 Medical devices — EN ISO 20417:2021
Information to be supplied by
the manufacturer
ISO 21920-2 ISO 21920-2:2021 Geometrical product EN ISO 21920-2:2022
specifications (GPS) —
Surface texture: Profile —
Part 2: Terms, definitions and
surface texture parameters
ASTM D412 None Standard Test Methods for None
Vulcanized Rubber and
Thermoplastic Elastomers —
Tension
ASTM D624-00 None Standard guide for evaluation None
(2020) of thermoplastic
polyurethane solids and
solutions for biomedical
applications
ASTM D792 None Standard Test Methods for None
Density and Specific Gravity
(Relative Density) of Plastics
by Displacement
ASTM D2240 None Standard Test Method for None
Rubber Property —
Reference in International Title Corresponding European
Clause 2 Standard Edition Standard Edition
Durometer Hardness
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
Europe
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