EN ISO 10993-6:2016

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

ISO 10993-6:2016 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
ISO 10993-6:2016 applies to materials that are
-      solid and non-absorbable,
-      non-solid, such as porous materials, liquids, gels, pastes, and particulates, and
-      degradable and/or absorbable, which may be solid or non-solid.
The test sample is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical or functional loading. This part of ISO 10993 can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might have been breached, in order to evaluate local tissue responses.
The local effects are evaluated by a comparison of the tissue response caused by a test sample to that caused by control materials used in medical devices whose clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or absorption/degradation of the material. In particular for degradable/absorbable materials, the degradation characteristics of the material and the resulting tissue response should be determined.
ISO 10993-6:2016 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties. Systemic toxicity studies conducted by implantation might satisfy the requirements of this part of ISO 10993. When conducting combined studies for evaluating local effects and systemic effects, the requirements of both standards is to be fulfilled.

Biologische Beurteilung von Medizinprodukten - Teil 6: Prüfungen auf lokale Effekte nach Implantationen (ISO 10993-6:2016)

Évaluation biologique des dispositifs médicaux - Partie 6: Essais concernant les effets locaux après implantation (ISO 10993-6:2016)

ISO 10993-6:2016 spécifie les méthodes d'essai pour l'évaluation des effets locaux après une implantation de biomatériaux destinés à être utilisés dans des dispositifs médicaux.
ISO 10993-6:2016 s'applique aux matériaux qui sont
-      solides et non absorbables,
-      non solides, comme les matériaux poreux, liquides, en gel, pâteux et particulaires, et
-      dégradables et/ou absorbables, qui peuvent être solides ou non solides.
L'échantillon d'essai est implanté dans un site et dans une espèce animale appropriés à l'évaluation de la sécurité biologique du matériau. Ces essais d'implantation ne sont pas destinés à évaluer ou à déterminer les performances de l'échantillon d'essai en matière de charge mécanique ou fonctionnelle. La présente partie de l'ISO 10993 peut également être appliquée à des dispositifs médicaux destinés à une utilisation topique dans des indications cliniques où la surface ou le revêtement pourrait perdre son intégrité, afin d'évaluer les réponses tissulaires locales.
Les effets locaux sont évalués par comparaison de la réponse tissulaire induite par un échantillon d'essai avec celle induite par des matériaux de contrôle utilisés dans des dispositifs médicaux dont les caractéristiques d'acceptabilité clinique et de biocompatibilité ont été établies. L'objectif des méthodes d'essai est de caractériser l'historique et l'évolution de la réponse tissulaire après l'implantation d'un dispositif médical ou biomatériau, y compris l'intégration finale ou l'absorption/dégradation du matériau. Particulièrement pour les matériaux dégradables/absorbables, il convient de déterminer les caractéristiques de dégradation du matériau et la réponse tissulaire résultante.
ISO 10993-6:2016 ne traite pas de la toxicité systémique, de la cancérogénicité, de la tératogénicité ou de la mutagénicité. Les études d'implantation à long terme destinées à l'évaluation des effets biologiques locaux pourraient, cependant, apporter des informations sur certaines de ces propriétés. Des études de toxicité systémique effectuées par implantation pourraient répondre aux exigences de la présente partie de l'ISO 10993. Lors de la réalisation d'études combinées pour l'évaluation des effets locaux et systémiques, les exigences des deux normes appliquées doivent être satisfaites.

Biološko ovrednotenje medicinskih pripomočkov - 6. del: Preskusi, povezani z lokalnimi učinki po implantaciji (ISO 10993-6:2016)

Ta del standarda ISO 10993 določa preskusne metode za oceno lokalnih učinkov po implantaciji biomaterialov, namenjenih za uporabo v medicinskih pripomočkih.
Ta del standarda ISO 10993 se uporablja za materiale, ki:
- so trdni in niso vpojni;
- niso trdni, npr. porozni materiali, tekočine, geli, paste in delci; ter
- so razgradljivi in/ali vpojni, ki so lahko trdni ali netrdni.
Preskusni vzorec je vsajen v mesto in živalsko vrsto, primerno za ovrednotenje
biološke varnosti materiala. Ti implantacijski preskusi niso namenjeni ovrednotenju ali določanju uspešnosti preskusnih vzorcev v smislu mehanske ali funkcionalne obremenitve. Ta del standarda ISO 10993 je mogoče uporabljati tudi za medicinske pripomočke, ki so namenjeni za lokalni nanos pri kliničnih indikacijah, pri katerih je površina ali sluznica morda predrta, za ovrednotenje odzivov lokalnega tkiva.
Lokalni učinki so ovrednoteni s primerjavo odziva tkiva, ki ga povzroči preskusni vzorec, in odziva, ki ga povzroči kontrolni material, ki se uporablja v medicinskih pripomočkih, katerih lastnosti klinične sprejemljivosti in biološke združljivosti so že bile ugotovljene. Namen preskusnih metod je opredelitev zgodovine in razvoja odzivov tkiva po implantaciji medicinskega pripomočka/biomateriala, vključno s končno integracijo ali absorpcijo/degradacijo materiala. Zlasti pri razgradljivih/vpojnih materialih je treba določiti degradacijske značilnosti materiala in posledični odziv tkiva.
Ta del standarda ISO 10993 ne zajema sistemske toksičnosti, kancerogenosti, teratogenosti ali mutagenosti. Kljub temu bi dolgoročne študije o implantaciji, namenjene ovrednotenju lokalnih bioloških učinkov, lahko zagotovile vpogled v nekatere od teh lastnosti. Študije o sistemski toksičnosti, opravljene z implantacijo, morda izpolnjujejo zahteve tega dela standarda ISO 10993. Pri izvajanju kombiniranih študij za ovrednotenje lokalnih in sistemskih učinkov, morajo biti izpolnjene zahteve obeh standardov.

General Information

• Status: Published
• Publication Date: 13-Dec-2016
• Withdrawal Date: 29-Jun-2017
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Drafting Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 14-Dec-2016
• Completion Date: 14-Dec-2016
• 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: 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/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: SIST EN ISO 10993-6:2017 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

Relations

• Replaces: EN ISO 10993-6:2009 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
• Effective Date: 14-Mar-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-6:2017
01-februar-2017
1DGRPHãþD
SIST EN ISO 10993-6:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO3UHVNXVLSRYH]DQL]
ORNDOQLPLXþLQNLSRLPSODQWDFLML,62
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
(ISO 10993-6:2016)
Biologische Beurteilung von Medizinprodukten - Teil 6: Prüfungen auf lokale Effekte nach
Implantationen (ISO 10993-6:2016)
Évaluation biologique des dispositifs médicaux - Partie 6: Essais concernant les effets
locaux après implantation (ISO 10993-6:2016)
Ta slovenski standard je istoveten z: EN ISO 10993-6:2016
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-6:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-6:2017

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SIST EN ISO 10993-6:2017


EN ISO 10993-6
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2016
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-6:2009
English Version

Biological evaluation of medical devices - Part 6: Tests for
local effects after implantation (ISO 10993-6:2016)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil 6:
6: Essais concernant les effets locaux après Prüfungen auf lokale Effekte nach Implantationen (ISO
implantation (ISO 10993-6:2016) 10993-6:2016)
This European Standard was approved by CEN on 4 November 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 10993-6:2016 E
worldwide for CEN national Members.

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SIST EN ISO 10993-6:2017
EN ISO 10993-6:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
Annex ZB (informative)  Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered . 7

2

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SIST EN ISO 10993-6:2017
EN ISO 10993-6:2016 (E)
European foreword
This document (EN ISO 10993-6:2016) has been prepared by Technical Committee ISO/TC 194
"Biological and clinical evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 “Biological and clinical evaluation of medical devices” 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 June 2017, and conflicting national standards shall be
withdrawn at the latest by June 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 10993-6:2009.
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 Directives.
For relationship with EU Directives, see informative Annex ZA and ZB, which are integral parts of this
...