SIST EN ISO 10993-5:2009/A11:2025

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

Biologische Beurteilung von Medizinprodukten - Teil 5: Prüfungen auf In-vitro-Zytotoxizität

Évaluation biologique des dispositifs médicaux - Partie 5: Essais concernant la cytotoxicité in vitro

Biološko ovrednotenje medicinskih pripomočkov - 5. del: Preskusi za ugotavljanje citotoksičnosti in vitro - Dopolnilo A11

General Information

• Status: Published
• Publication Date: 01-Apr-2025
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 13-Mar-2025
• Due Date: 18-May-2025
• Completion Date: 02-Apr-2025
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: EN ISO 10993-5:2009/A11:2025 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

Relations

• Amends: SIST EN ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
• Effective Date: 01-May-2025

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2025
Biološko ovrednotenje medicinskih pripomočkov - 5. del: Preskusi za ugotavljanje
citotoksičnosti in vitro - Dopolnilo A11
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Biologische Beurteilung von Medizinprodukten - Teil 5: Prüfungen auf In-vitro-
Zytotoxizität
Évaluation biologique des dispositifs médicaux - Partie 5: Essais concernant la
cytotoxicité in vitro
Ta slovenski standard je istoveten z: EN ISO 10993-5:2009/A11:2025
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 10993-
EUROPEAN STANDARD
5:2009/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2025
ICS 11.100.20
English Version
Biological evaluation of medical devices - Part 5: Tests for
in vitro cytotoxicity
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil 5:
5: Essais concernant la cytotoxicité in vitro Prüfungen auf In-vitro-Zytotoxizität
This amendment A11 modifies the European Standard EN ISO 10993-5:2009; it was approved by CEN on 29 January 2025.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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 10993-5:2009/A11:2025 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 10993-5:2009/A11:2025) has been prepared by Technical Committee
CEN/TC 206 “Biological and clinical evaluation of medical devices”, the secretariat of which is held by
DIN.
This Amendment to the European Standard EN ISO 10993-5:2009 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by September 2025,
and conflicting national standards shall be withdrawn at the latest by September 2025.
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 amends EN ISO 10993-5:2009 with a revised European Foreword and the European
Annex ZA.
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.
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
...