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EN ISO 10993-11:2018

(Main)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische Toxizität (ISO 10993-11:2017)

Dieses Dokument legt Anforderungen an Verfahren fest und gibt eine Anleitung, die bei der Beurteilung des Potenzials von Materialien für Medizinprodukte zur Auslösung nachteiliger systemischer Reaktionen zu befolgen sind.

Évaluation biologique des dispositifs médicaux - Partie 11: Essais de toxicité systémique (ISO 10993-11:2017)

ISO 10993-11:2017 spécifie des exigences et fournit des préconisations quant aux modes opératoires à suivre pour évaluer les éventuelles réactions systémiques défavorables causées par les matériaux de dispositifs médicaux.

Biološko ovrednotenje medicinskih pripomočkov - 11. del: Preskusi sistemske toksičnosti (ISO 10993-11:2017)

Ta del standarda ISO 10993 opisuje postopek za presojo medicinskih pripomočkov in njihovih sestavnih materialov glede njihovega potenciala za povzročitev draženja in preobčutljivosti kože.
Ta del standarda ISO 10993 vključuje:
a) premisleke glede draženja pred preskusom, vključno z metodami in silico in in vitro za izpostavljenost kože;
b) podrobnosti preskusnih postopkov in vivo (draženje in preobčutljivost);
c) ključne dejavnike za razlago rezultatov.
V Dodatku A so podana navodila za pripravo materialov, zlasti v zvezi z zgornjimi preskusi. V Dodatku B je opisanih več posebnih preskusov draženja pri uporabi medicinskih pripomočkov na drugih delih telesa (ne na koži).

General Information

Status
Published
Publication Date
29-May-2018
Withdrawal Date
29-Nov-2018
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
30-May-2018
Completion Date
30-May-2018
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
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
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 10993-11:2018 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

Relations

Replaces
EN ISO 10993-11:2009 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
Effective Date
06-Jun-2018

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Related Packages

ISO 10993 - Biological Evaluation of Medical Devices Package
ISO 10993 - Biological Evaluation of Medical Devices Package
20 documents

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-11:2018
01-september-2018
Nadomešča:
SIST EN ISO 10993-11:2009
Biološko ovrednotenje medicinskih pripomočkov - 11. del: Preskusi sistemske
toksičnosti (ISO 10993-11:2017)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-
11:2017)
Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische
Toxizität (ISO 10993-11:2017)
Évaluation biologique des dispositifs médicaux - Partie 11: Essais de toxicité systémique
(ISO 10993-11:2017)
Ta slovenski standard je istoveten z: EN ISO 10993-11:2018
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
SIST EN ISO 10993-11:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 10993-11:2018

---------------------- Page: 2 ----------------------
SIST EN ISO 10993-11:2018


EN ISO 10993-11
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2018
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-11:2009
English Version

Biological evaluation of medical devices - Part 11: Tests for
systemic toxicity (ISO 10993-11:2017)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil
11: Essais de toxicité systémique (ISO 10993-11:2017) 11: Prüfungen auf systemische Toxizität (ISO 10993-
11:2017)
This European Standard was approved by CEN on 31 July 2017.

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 10993-11:2018 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 10993-11:2018
EN ISO 10993-11:2018 (E)
Contents Page
European foreword . 3
Endorsement notice . 4
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

---------------------- Page: 4 ----------------------
SIST EN ISO 10993-11:2018
EN ISO 10993-11:2018 (E)
European foreword
This document (EN ISO 10993-11:2018) 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 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 10993-11:2009.
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
...

SLOVENSKI STANDARD
SIST EN ISO 10993-11:2018
01-september-2018
1DGRPHãþD
SIST EN ISO 10993-11:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO3UHVNXVLVLVWHPVNH
WRNVLþQRVWL ,62
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-
11:2017)
Biologische Beurteilung von Medizinprodukten - Teil 11: Prüfungen auf systemische
Toxizität (ISO 10993-11:2017)
Évaluation biologique des dispositifs médicaux - Partie 11: Essais de toxicité systémique
(ISO 10993-11:2017)
Ta slovenski standard je istoveten z: EN ISO 10993-11:2018
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-11:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 10993-11:2018

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

SIST EN ISO 10993-11:2018


EN ISO 10993-11
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2018
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-11:2009
English Version

Biological evaluation of medical devices - Part 11: Tests for
systemic toxicity (ISO 10993-11:2017)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil
11: Essais de toxicité systémique (ISO 10993-11:2017) 11: Prüfungen auf systemische Toxizität (ISO 10993-
11:2017)
This European Standard was approved by CEN on 31 July 2017.

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 10993-11:2018 E
worldwide for CEN national Members.

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

SIST EN ISO 10993-11:2018
EN ISO 10993-11:2018 (E)
Contents Page
European foreword . 3
Endorsement notice . 4
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

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

SIST EN ISO 10993-11:2018
EN ISO 10993-11:2018 (E)
European foreword
This document (EN ISO 10993-11:2018) 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 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 10993-11:2009.
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 Direc
...

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