Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

This document specifies:
—          the general principles governing the biological evaluation of medical devices within a risk management process;
—          the general categorization of medical devices based on the nature and duration of their contact with the body;
—          the evaluation of existing relevant data from all sources;
—          the identification of gaps in the available data set on the basis of a risk analysis;
—          the identification of additional data sets necessary to analyse the biological safety of the medical device;
—          the assessment of the biological safety of the medical device.
This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with:
—          the patient's body during intended use;
—          the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).
This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.
This document also gives guidelines for the assessment of biological hazards arising from:
—          risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;
—          breakage of a medical device or medical device component which exposes body tissue to new or novel materials.
Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.

Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im Rahmen eines Risikomanagementsystems (ISO 10993-1:2018, einschließlich korrigierte Fassung 2018-10)

Dieses Dokument legt das Folgende fest:
- die allgemeinen Grundsätze, die für die biologische Beurteilung von Medizinprodukten innerhalb eines Risikomanagementverfahrens gelten;
- die allgemeine Einteilung von Medizinprodukten, basierend auf der Art und Dauer von deren Kontakt mit dem Körper;
- die Auswertung vorhandener relevanter Daten aus allen Quellen;
- die Ermittlung von Lücken in den verfügbaren Datensätzen auf der Grundlage einer Risikoanalyse;
- die Ermittlung zusätzlicher Datensätze, die für die Analyse der biologischen Sicherheit des Medizin¬produkts notwendig sind;
- die Beurteilung der biologischen Sicherheit des Medizinprodukts.
Dieses Dokument gilt für die Beurteilung von Materialien und Medizinprodukten, von denen erwartet wird, dass sie direkt oder indirekt in Kontakt kommen mit
- dem Körper des Patienten im Rahmen der bestimmungsgemäßen Verwendung, und/oder
- dem Körper des Anwenders, wenn das Medizinprodukt zum Schutz vorgesehen ist (z. B. OP-Hand-schuhe, Masken und andere Produkte).
Dieses Dokument ist anwendbar auf die biologische Beurteilung aller Arten an Medizinprodukten, einschließlich aktiver, nicht aktiver, implantierbarer und nicht implantierbarer Medizinprodukte.
Dieses Dokument bietet außerdem einen Leitfaden zur Beurteilung von biologischen Gefährdungen aufgrund von
- Risiken, wie etwa Veränderungen des Medizinprodukts im Laufe der Zeit, als Teil der biologischen Sicherheitsbewertung, und/oder
- Beschädigung eines Medizinprodukts oder eines Bestandteils des Medizinprodukts, was zur Folge hat, dass Körpergewebe neuen oder neu entstandenen Materialien ausgesetzt wird.
Andere Teile der ISO 10993 decken spezifische Aspekte der biologischen Beurteilungen und zugehörigen Prüfungen ab. Spezifische Normen für das Medizinprodukt oder Produktnormen behandeln die mechanische Prüfung.
Gefährdungen im Zusammenhang mit Bakterien, Schimmelpilzen, Hefen, Viren, den Erregern der Trans¬missiblen Spongiformen Enzephalopathie (TSE) und weiteren pathogenen Organismen werden in diesem Dokument nicht behandelt.

Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque (ISO 10993-1:2018, y compris version corrigée 2018-10)

Le présent document spécifie:
—          les principes généraux sur lesquels repose l'évaluation biologique des dispositifs médicaux dans un processus de gestion du risque;
—          la classification générale des dispositifs médicaux, fondée sur la nature et la durée de leur contact avec le corps humain;
—          l'évaluation de toutes les données pertinentes existantes;
—          l'identification de lacunes dans les ensembles de données disponibles sur la base d'une analyse de risque;
—          l'identification d'ensembles de données supplémentaires nécessaires à l'analyse de la sécurité biologique du dispositif médical;
—          l'évaluation de la sécurité biologique du dispositif médical.
Le présent document s'applique à l'évaluation de matériaux et dispositifs médicaux qui sont destinés à entrer en contact direct ou indirect avec:
—          le corps du patient pendant leur utilisation prévue;
—          le corps de l'utilisateur si le dispositif médical est destiné à la protection (par exemple gants chirurgicaux, masques et autres).
Le présent document est applicable à l'évaluation biologique de tous types de dispositifs médicaux, y compris les dispositifs médicaux actifs, non actifs, implantables et non implantables.
Le présent document donne également des lignes directrices pour l'évaluation des dangers biologiques provenant de:
—          risques tels que des modifications du dispositif médical au fil du temps, dans le cadre de l'évaluation de sécurité biologique générale;
—          rupture d'un dispositif médical ou d'un composant de dispositif médical qui expose des tissus de l'organisme à des matériaux nouveaux.
Les autres parties de l'ISO 10993 couvrent des aspects spécifiques des évaluations biologiques et des essais associés. Des normes de produits ou spécifiques aux dispositifs traitent des essais mécaniques.
Le présent document exclut les dangers relatifs aux bactéries, moisissures, levures, virus, agents de l'encéphalopathie spongiforme transmissible (EST) et autres agents pathogènes.

Biološko ovrednotenje medicinskih pripomočkov - 1. del: Ocena in preskušanje znotraj procesa obvladovanja tveganja (ISO 10993-1:2018, vključno s popravkom verzije 2018-11)

General Information

Status
Published
Publication Date
15-Dec-2020
Withdrawal Date
29-Jun-2021
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-Dec-2020
Completion Date
16-Dec-2020

Relations

Buy Standard

Standard
EN ISO 10993-1:2021
English language
50 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day
Draft
prEN ISO 10993-1:2017
English language
51 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-1:2021
01-februar-2021
Nadomešča:
SIST EN ISO 10993-1:2010
SIST EN ISO 10993-1:2010/AC:2010
Biološko ovrednotenje medicinskih pripomočkov - 1. del: Ocena in preskušanje
znotraj procesa obvladovanja tveganja (ISO 10993-1:2018, vključno s popravkom
verzije 2018-11)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process (ISO 10993-1:2018, including corrected version 2018-11)
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im
Rahmen eines Risikomanagementsystems (ISO 10993-1:2018, einschließlich korrigierte
Fassung 2018-11)
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein
d'un processus de gestion du risque (ISO 10993-1:2018, y compris version corrigée
2018-11)
Ta slovenski standard je istoveten z: EN ISO 10993-1:2020
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
SIST EN ISO 10993-1:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 10993-1:2021

---------------------- Page: 2 ----------------------
SIST EN ISO 10993-1:2021


EN ISO 10993-1
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2020
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-1:2009
English Version

Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
(ISO 10993-1:2018, including corrected version 2018-11)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil 1:
1: Évaluation et essais au sein d'un processus de Beurteilung und Prüfungen im Rahmen eines
gestion du risque (ISO 10993-1:2018, y compris Risikomanagementsystems (ISO 10993-1:2018,
version corrigée 2018-11) einschließlich korrigierte Fassung 2018-11)
This European Standard was approved by CEN on 10 December 2020.

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, 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-1:2020 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 10993-1:2021
EN ISO 10993-1:2020 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 10993-1:2021
EN ISO 10993-1:2020 (E)
European foreword
This document (EN ISO 10993-1:2020) 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 2021, and conflicting national standards shall be
withdrawn at the latest by June 2021.
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 10993-1:2009.
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,
...

SLOVENSKI STANDARD
oSIST prEN ISO 10993-1:2017
01-maj-2017
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO2FHQDLQSUHVNXãDQMH
]QRWUDMSURFHVDREYODGRYDQMDWYHJDQMD ,62',6
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process (ISO/DIS 10993-1:2017)
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im
Rahmen eines Risikomanagementsystems (ISO/DIS 10993-1:2017)
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein
d'un processus de gestion du risque (ISO/DIS 10993-1:2017)
Ta slovenski standard je istoveten z: prEN ISO 10993-1
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
oSIST prEN ISO 10993-1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 10993-1:2017

---------------------- Page: 2 ----------------------
oSIST prEN ISO 10993-1:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10993-1
ISO/TC 194 Secretariat: DIN
Voting begins on: Voting terminates on:
2017-02-20 2017-05-14
Biological evaluation of medical devices —
Part 1:
Evaluation and testing within a risk management process
Évaluation biologique des dispositifs médicaux —
Partie 1: Évaluation et essais au sein d’un processus de gestion du risque
ICS: 11.100.20
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 10993-1:2017(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 10993-1:2017
ISO/DIS 10993-1:2017(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 10993-1:2017
ISO/DIS 10993-1:2017(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General principles applying to biological evaluation of medical devices .5
5 Categorization of medical devices . 9
5.1 General . 9
5.2 Categorization by nature of body contact .
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.