SIST EN ISO 10993-1:2010
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
This part of ISO 10993 describes:
a) the general principles governing the biological evaluation of medical devices within a risk managementframework;
b) the general categorization of devices based on the nature and duration of their contact with the body;
c) the evaluation of existing relevant data from all sources;d) the identification of gaps in the available data set on the basis of a risk analysis;
e) the identification of additional data sets necessary to analyze the biological safety of the medical device;
f) the assessment of the biological safety of the medical device.
This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests as indicated in the foreword.
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im Rahmen eines Risikomanagementsystems (ISO 10993-1:2009)
Dieser Teil von ISO 10993 beschreibt
die allgemeinen Grundsätze, die für die biologische Beurteilung von Medizinprodukten im Rahmen eines Risikomanagements 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-produktes notwendig sind;
die Beurteilung der biologischen Sicherheit des Medizinproduktes.
Dieser Teil von ISO 10993 gilt nicht für Prüfungen von Materialien und Produkten, die weder direkt noch indirekt mit dem Körper des Patienten in Kontakt kommen; diese Norm schließt auch keine Biogefährdungen ein, die durch mechanisches Versagen hervorgerufen werden. Andere Teile der ISO 10993 decken spezifische Prüfungen ab, wie im Vorwort angegeben.
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque (ISO 10993-1:2009)
L'ISO 10993-1:2009 décrit
les principes généraux sur lesquels repose l'évaluation biologique des dispositifs médicaux dans un processus de gestion des risques,
la classification générale des dispositifs, fondée sur la nature et la durée de leur contact avec le corps humain,
l'évaluation de toutes les données existantes,
l'identification de manques 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 et l'évaluation de la sécurité biologique du dispositif médical.
Biološko ovrednotenje medicinskih pripomočkov - 1. del: Ocena in preskušanje znotraj procesa obvladovanja tveganja (ISO 10993-1:2009)
Ta del standarda ISO 10993 opisuje: - splošna načela, ki veljajo za biološko ovrednotenje medicinskih pripomočkov znotraj procesa obvladovanja tveganja; - splošno razvrščanje pripomočkov na osnovi narave in trajanja njihovega stika s telesom; - ovrednotenje obstoječih ustreznih podatkov iz vseh virov; - identifikacijo vrzeli v razpoložljivem podatkovnem nizu na osnovi analize tveganja; - identifikacijo dodatnih podatkovnih nizov, potrebnih za analizo biološke varnosti medicinskega pripomočka; - ocenjevanje biološke varnosti medicinskega pripomočka. Ta del standarda ISO 10993 ne zajema preskušanja materialov in pripomočkov, ki ne prihajajo v neposreden ali posreden stik z bolnikovim telesom, ter ne zajema bioloških nevarnosti, ki izhajajo iz kakršne koli mehanske okvare. Drugi deli standarda ISO 10993 zajemajo posebne preskuse, navedene v Predgovoru.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10993-1:2010
01-januar-2010
1DGRPHãþD
SIST EN ISO 10993-1:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO 2FHQDLQSUHVNXãDQMH
]QRWUDMSURFHVDREYODGRYDQMDWYHJDQMD ,62
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process (ISO 10993-1:2009)
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im
Rahmen eines Risikomanagementsystems (ISO 10993-1:2009)
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein
d'un processus de gestion du risque (ISO 10993-1:2009)
Ta slovenski standard je istoveten z: EN ISO 10993-1:2009
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-1:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 10993-1:2010
---------------------- Page: 2 ----------------------
SIST EN ISO 10993-1:2010
EUROPEAN STANDARD
EN ISO 10993-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2009
ICS 11.100.20 Supersedes EN ISO 10993-1:2009, June
English Version
Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process (ISO 10993-1:2009)
Évaluation biologique des dispositifs médicaux - Partie 1: Biologische Beurteilung von Medizinprodukten - Teil 1:
Évaluation et essais au sein d'un processus de gestion du Beurteilung und Prüfungen im Rahmen eines
risque (ISO 10993-1:2009) Risikomanagementsystems (ISO 10993-1:2009)
This European Standard was approved by CEN on 17 September 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-1:2009: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 10993-1:2010
EN ISO 10993-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices .4
Annex ZB (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .5
2
---------------------- Page: 4 ----------------------
SIST EN ISO 10993-1:2010
EN ISO 10993-1:2009 (E)
Foreword
This document (EN ISO 10993-1:2009) has been prepared by Technical Committee ISO/TC 194 "Biological
evaluation of medical devices" in collaboration with Technical Committee CEN/TC 206 “Biological evaluation
of medical devices” the secretariat of which is held by NEN.
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 April 2010, and conflicting national standards shall be withdrawn at the
latest by April 2010.
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 10993-1:2009, June.
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
document.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10993-1:2009 has been approved by CEN as a EN ISO 10993-1:2009 without any
modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 10993-1:2010
EN ISO 10993-1:2009 (E)
Annex ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on Medical devices.
Once this International Standard is cited in the Official Journal of the European Union under that Directive and
has been implemented as a national standard in at least one Member State, compliance with the clauses of
this International Standard given in Table ZA.1 confers, within the limits of the scope of this Intenational
Standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and
associated EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC on
Medical devices
Essential Requirements (ERs) of
Clause(s)/subclause(s) of this Qualifying remarks/notes
Directive 93/42/EEC on Medical
International Standard
devices
4, 5, 6, 7 Annex I:
7.1, 7.2 and 7.5
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this International Standard.
4
---------------------- Page: 6 ----------------------
SIST EN ISO 10993-1:2010
EN ISO 10993-1:2009 (E)
Annex ZB
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical
Devices
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on Active Implantable Medical Devices.
Once this International Standard is cited in the Official Journal of the European Union under that Directive and
has been implemented as a national standard in at least one Member State, compliance with the clauses of
this International Standard given in Table ZB.1 confers, within the limits of the scope of this International
Standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and
associated EFTA regulations.
Table ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC on Active
Implantable Medical Devices
Essential Requirements (ERs) of
Clause(s)/subclause(s) of this Qualifying remarks/notes
Directive 90/385/EEC on Active
International Standard
Implantable Medical Devices
4, 5, 6, 7 Annex I:
Indents 1 and 2 of Clause 9 only
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this International Standard.
5
---------------------- Page: 7 ----------------------
SIST EN ISO 10993-1:2010
---------------------- Page: 8 ----------------------
SIST EN ISO 10993-1:2010
INTERNATIONAL ISO
STANDARD 10993-1
Fourth edition
2009-10-15
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
Reference number
ISO 10993-1:2009(E)
©
ISO 2009
---------------------- Page: 9 ----------------------
SIST EN ISO 10993-1:2010
ISO 10993-1:2009(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2009
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2009 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 10993-1:2010
ISO 10993-1:2009(E)
Contents Page
Foreword .iv
Introduction.vi
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 General principles applying to biological evaluation of medical devices.3
5 Categorization of medical devices .6
5.1 General .6
5.2 Categorization by nature of body contact .6
5.3 Categorization by duration of contact.7
6 Biological evaluation process.8
6.1 Material characterization .8
6.2 Biological evaluation tests .8
7 Interpretation of biological evaluation data and overall biological safety assessment .14
Annex A (informative) Biological evaluation tests .15
Annex B (informative) Guidance on the risk management process.16
Annex C (informative) Suggested procedure for literature review .19
Bibliography.21
© ISO 2009 – All rights reserved iii
---------------------- Page: 11 ----------------------
SIST EN ISO 10993-1:2010
ISO 10993-1:2009(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10993-1 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.
This fourth edition cancels and replaces the third edition (ISO 10993-1:2003), which has been technically
revised.
ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices:
⎯ Part 1: Evaluation and testing within a risk management process
⎯ Part 2: Animal welfare requirements
⎯ Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
⎯ Part 4: Selection of tests for interactions with blood
⎯ Part 5: Tests for in vitro cytotoxicity
⎯ Part 6: Tests for local effects after implantation
⎯ Part 7: Ethylene oxide sterilization residuals
⎯ Part 9: Framework for identification and quantification of potential degradation products
⎯ Part 10: Tests for irritation and skin sensitization
⎯ Part 11: Tests for systemic toxicity
⎯ Part 12: Sample preparation and reference materials
⎯ Part 13: Identification and quantification of degradation products from polymeric medical devices
⎯ Part 14: Identification and quantification of degradation products from ceramics
⎯ Part 15: Identification and quantification of degradation products from metals and alloys
iv © ISO 2009 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 10993-1:2010
ISO 10993-1:2009(E)
⎯ Part 16: Toxicokinetic study design for degradation products and leachables
⎯ Part 17: Establishment of allowable limits for leachable substances
⎯ Part 18: Chemical characterization of materials
⎯ Part 19: Physico-chemical, morphological and topographical characterization of materials (Technical
Specification)
⎯ Part 20: Principles and methods for immunotoxicology testing of medical devices (Technical
Specification)
Future parts will deal with other relevant aspects of biological evaluation.
© ISO 2009 – All rights reserved v
---------------------- Page: 13 ----------------------
SIST EN ISO 10993-1:2010
ISO 10993-1:2009(E)
Introduction
The primary aim of this part of ISO 10993 is the protection of humans from potential biological risks arising
from the use of medical devices. It is compiled from numerous International and National Standards and
Guidelines concerning the biological evaluation of medical devices. It is intended to be a guidance document
for the biological evaluation of medical devices within a risk management process, as part of the overall
evaluation and development of each device. This approach combines the review and evaluation of existing
data from all sources with, where necessary, the selection and application of additional tests, thus enabling a
full evaluation to be made of the biological responses to each medical device, relevant to its safety in use. It
must be appreciated that the term “medical device” is wide-ranging and, at one extreme, consists of a single
material, which may exist in more than one physical form, and at the other extreme, of a complex instrument
or piece of apparatus, consisting of numerous components made of more than one material.
ISO 10993 addresses the determination of the effects of medical devices on tissues, mostly in a general way,
rather than in a specific device-type situation. Thus, for a complete biological safety evaluation, it classifies
medical devices according to the nature and duration of their anticipated contact with human tissues when in
use and indicates, in matrices, the biological data sets that are thought to be relevant in the consideration of
each device category.
The range of biological hazards is wide and complex. The tissue interaction with a constituent material alone
cannot be considered in isolation from the overall device design. Thus, in designing a device, the choice of the
best material with respect to its tissue interaction might result in a less functional device, tissue interaction
being only one of a number of characteristics to be considered in making that choice. Where a material is
intended to interact with tissue in order to perform its function, the biological evaluation needs to address this.
Tissue interactions that are regarded as adverse, caused by a material in one application, might not be
regarded as such in a different situation. Biological testing is based upon, among other things, in vitro and ex
vivo test methods and upon animal models, so that the anticipated behaviour when a device is used in
humans can be adjudged only with caution, as it cannot be unequivocally concluded that the same tissue
reactions will also occur in this species. In addition, differences in the manner of response to the same
material among individuals indicate that some patients can have adverse reactions, even to well-established
materials.
The role of this part of ISO 10993 is to serve as a framework in which to plan a biological evaluation which, as
scientific knowledge advances our understanding of the basic mechanisms of tissue responses, minimizes the
number and exposure of test animals by giving preference to chemical constituent testing and in vitro models,
in situations where these methods yield equally relevant information to that obtained from in vivo models.
It is not intended that ISO 10993 provide a rigid set of test methods, including pass/fail criteria, as this might
result in either an unnecessary constraint on the development and use of novel medical devices, or a false
sense of security in the general use of medical devices. Where a particular application warrants it, experts in
the product or in the area of application concerned can choose to establish specific tests and criteria,
described in a product-specific vertical standard.
This part of ISO 10993 is intended for use by professionals, appropriately qualified by training and experience,
who are able to interpret its requirements and judge the outcome of the evaluation for each medical device,
taking into consideration all the factors relevant to the device, its intended use and the current knowledge of
the medical device provided by review of the scientific literature and previous clinical experience.
Annex A contains an informative table that is generally helpful in identifying biological data sets recommended
in the evaluation of medical devices, according to their category of body contact and duration of clinical
exposure. Annex B contains guidance for the application of the risk management process to medical devices
which encompasses biological evaluation.
vi © ISO 2009 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 10993-1:2010
INTERNATIONAL STANDARD ISO 10993-1:2009(E)
Biological evaluation of medical devices —
Part 1:
Evaluation and testing within a risk management process
1 Scope
This part of ISO 10993 describes:
⎯ the general principles governing the biological evaluation of medical devices within a risk management
process;
⎯ the general categorization of 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 part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect
contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other
parts of ISO 10993 cover specific tests, as indicated in the Foreword.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only
the edition cited applies. For undated references, the latest edition of the referenced document (including any
amendments) applies.
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and
reproductive toxicity
ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interaction with blood
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-9, Biological evaluation of medical devices — Part 9: Framework for identification and
quantification of potential degradation products
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
© ISO 2009 – All rights reserved 1
---------------------- Page: 15 ----------------------
SIST EN ISO 10993-1:2010
ISO 10993-1:2009(E)
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-12, Biological evaluation of medical devices — Part 12: Sample preparation and reference
materials
ISO 10993-13, Biological evaluation of medical devices — Part 13: Identification and quantification of
degradation products from polymeric medical devices
ISO 10993-14, Biological evaluation of medical devices — Part 14: Identification and quantification of
degradation products from ceramics
ISO 10993-15, Biological evaluation of medical devices — Part 15: Identification and quantification of
degradation products from metals and alloys
ISO 10993-16, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation
products and leachables
ISO 10993-17, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for
leachable substances
ISO 10993-18:2005, Biological evaluation of medical devices — Part 18: Chemical characterization of
materials
ISO/TS 10993-19, Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and
topographical characterization of materials
ISO/TS 10993-20, Biological evaluation of medical devices — Part 20: Principles and methods for
immunotoxicology testing of medical devices
ISO 14971, Medical Devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article, intended by the manufacturer to be used, alone or in combination,
for human beings for one or more of the specific purpose(s) of:
⎯ diagnosis, prevention, monitoring, treatment or alleviation of disease,
⎯ diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
⎯ investigation, replacement, modification, or support of the anatomy or of a physiological process,
⎯ supporting or sustaining life,
⎯ control of conception,
⎯ disinfection of medical devices,
⎯ providing information for medical purposes by means of in vitro examination of specimens derived from
the human body,
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
NOTE 1 This definition has been developed by the Global Harmonization Task Force (GHTF).
[ISO 13485:2003, definition 3.7]
2 © ISO 2009 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 10993-1:2010
ISO 10993-1:2009(E)
NOTE 2 Products which might be considered to be medical devices in some jurisdictions but for which there is not yet
a harmonized approach, are:
1) aids for disabled/handicapped people;
2) devices for the treatment/diagnosis of diseases and injuries in animals;
3) accessories for medical devices (see Note 4);
4) disinfection substances;
5) devices incorporating animal and human tissues, which might meet the requirements of the above definition but
are subject to different controls.
NOTE 3 Accessories intended specifically by manufacturers to be used together with a “parent” medical device to
enable that medical device to achieve its intended purpose, should be subject to ISO 10993.
NOTE 4 Medical devices are different from drugs/biologics, and their biological evaluation requires a different approach.
NOTE 5 Medical devices can include dental devices.
3.2
material
any synthetic or natural polymer, metal, alloy, ceramic or other non-viable substance, including tissue
rendered non-viable, used as a medical device or any part thereof
3.3
final product
medical device in its “as-used” state, as defined by the manufacturer's specification or labelling
3.4
chemical constituent
any synthetic or natural substance that is used in a process for manufacturing materials and/or medical
devices, such as additives (antioxidants, UV stabilizers, dyestuff, etc.), processing aids (solvents, lubricants,
antifoaming agents, etc.)
3.5
data set
information from a variety of sources necessary to characterize the biological response of a device
4 General principles applying to biological evaluation of medical devices
4.1 The biological evaluation of any material or medical device intended for use in humans shall form part
of a structured biological evaluation programme within a risk management process in accordance with
ISO 14971, as set out in Figure 1. Annex B provides guidance on this process. The biological evaluation shall
be planned, carried out, and documented by knowledgeable and experienced professionals. See Annex C for
how to perform a literature review of existing data.
The risk management plan should identify aspects of the biological evaluation requiring specific technical
competencies and shall identify the person(s) responsible for the biological safety evaluation.
The evaluation programme shall include documented, informed decisions that assess the
advantages/disadvantages and relevance of:
a) the physical and chemical characteristics of the various candidate materials;
NOTE Where this information is already documented within the risk management for the device it can be included by
reference.
© ISO 2009 – All rights reserved 3
---------------------- Page: 17 ----------------------
SIST EN ISO 10993-1:2010
ISO 10993-1:2009(E)
b) any history of clinical use or human exposure data;
c) any existing toxicology and other biological safety data on product and component materials, breakdown
products and metabolites;
d) test procedures.
Evaluation may include both a study of relevant preclinical and clinical experience and actual testing. Such an
evaluation might result in the conclusion that no testing is needed if the material has a demonstrable safe
history of use in a specified role and physical form that is equivalent to that of the device und
...
SLOVENSKI STANDARD
oSIST prEN ISO 10993-1:2007
01-januar-2007
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO 2FHQDLQSUHVNXãDQMH
]QRWUDMVLVWHPDREYODGRYDQMDWYHJDQMD ,62',6
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management system (ISO/DIS 10993-1:2006)
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im
Rahmen eines Risikomanagementsystems (ISO/DIS 10993-1:2006)
Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein
d'un systeme de gestion du risque (ISO/DIS 10993-1:2006)
Ta slovenski standard je istoveten z: prEN ISO 10993-1
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
oSIST prEN ISO 10993-1:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 10993-1:2007
---------------------- Page: 2 ----------------------
oSIST prEN ISO 10993-1:2007
EUROPEAN STANDARD
DRAFT
prEN ISO 10993-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2006
ICS 11.100 Will supersede EN ISO 10993-1:2003
English Version
Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management system (ISO/DIS 10993-
1:2006)
Évaluation biologique des dispositifs médicaux - Partie 1:
Évaluation et essais au sein d'un système de gestion du
risque (ISO/DIS 10993-1:2006)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 206.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 10993-1:2006: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN ISO 10993-1:2007
prEN ISO 10993-1:2006 (E)
Foreword
This document (prEN ISO 10993-1:2006) has been prepared by Technical Committee ISO/TC
194 "Biological evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 "Biocompatibility of medical and dental materials and devices", the secretariat of
which is held by NEN.
This document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 10993-1:2003.
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).
Endorsement notice
The text of ISO 10993-1:2006 has been approved by CEN as prEN ISO 10993-1:2006 without
any modifications.
2
---------------------- Page: 4 ----------------------
oSIST prEN ISO 10993-1:2007
DRAFT INTERNATIONAL STANDARD ISO/DIS 10993-1
ISO/TC 194 Secretariat: DIN
Voting begins on: Voting terminates on:
2006-11-02 2007-04-02
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Biological evaluation of medical devices —
Part 1:
Evaluation and testing within a risk management system
Évaluation biologique des dispositifs médicaux —
Partie 1: Évaluation et essais au sein d'un système de gestion du risque
[Revision of third edition (ISO 10993-1:2003)]
ICS 11.100.20
ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject
of interest to European standardization. In accordance with the ISO-lead mode of collaboration as
defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN
members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a
final draft, established on the basis of comments received, will be submitted to a parallel two-month FDIS
vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED 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 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 NATIONAL REGULATIONS.
© International Organization for Standardization, 2006
---------------------- Page: 5 ----------------------
oSIST prEN ISO 10993-1:2007
ISO/DIS 10993-1
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying,
recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO's
member body in the country of the requester.
ISO copyright office
Case postale 56 CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
©
ii ISO 2006 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 10993-1:2007
ISO/DIS 10993-1
Contents Page
Foreword .iv
Introduction.vi
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 General principles applying to biological evaluation of medical devices.3
5 Categorization of medical devices .7
5.1 General .7
5.2 Categorization by nature of body contact .7
5.2.1 Surface-contacting devices.7
5.2.2 External communicating devices .7
5.2.3 Implant devices.8
5.3 Categorization by duration of contact.8
6 Biological evaluation process.8
6.1 Material characterization .8
6.2 Biological evaluation tests .9
6.2.1 General .9
6.2.2 Test descriptions.10
7 Interpretation of biological evaluation data and overall biological safety assessment .14
Annex A (informative) Biological evaluation tests .15
Annex B (informative) Guidance on the risk management process.17
B.1 General.17
B.2 Risk management process.17
B.2.1 Risk analysis.17
B.2.2 Overall residual risk/benefit evaluation .18
B.2.3 Biological evaluation report .18
B.2.4 Post-production information.18
B.3 Testing and test reports.19
B.4 Biological evaluation report .19
B.5 Conclusion.19
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive (Add the reference and title of the Directive).20
Bibliography.21
© ISO 2006 – All rights reserved iii
---------------------- Page: 7 ----------------------
oSIST prEN ISO 10993-1:2007
ISO/DIS 10993-1
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10993-1 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices,
and by Technical Committee CEN/TC 206, Biological evaluation of medical devices in collaboration.
This third edition cancels and replaces the second edition (EN ISO 10993-1:2003), which has been technically
revised.
ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices:
⎯ Part 1: Evaluation and testing within a risk management system
⎯ Part 2: Animal welfare requirements
⎯ Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
⎯ Part 4: Selection of tests for interactions with blood
⎯ Part 5: Tests for in vitro cytotoxicity
⎯ Part 6: Tests for local effects after implantation
⎯ Part 7: Ethylene oxide sterilization residuals
⎯ Part 9: Framework for the identification and quantification of potential degradation products
⎯ Part 10: Tests for irritation and delayed-type hypersensitivity
⎯ Part 11: Tests for systemic toxicity
⎯ Part 12: Sample preparation and reference materials
⎯ Part 13: Identification and quantification of degradation products from polymeric medical devices
⎯ Part 14: Identification and quantification of degradation products from ceramics
⎯ Part 15: Identification and quantification of degradation products from metals and alloys
iv © ISO 2006 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 10993-1:2007
ISO/DIS 10993-1
⎯ Part 16: Toxicokinetic study design for degradation products and leachables
⎯ Part 17: Method for the establishment of allowable limits for leachable substances
⎯ Part 18: Chemical characterization of materials
⎯ Part 19: Physico-chemical, morphological and topographical characterization of materials
⎯ Part 20: Principles and methods for immunotoxicology testing of medical devices
Future parts will deal with other relevant aspects of biological testing.
Annexes A and B are for information only.
© ISO 2006 – All rights reserved v
---------------------- Page: 9 ----------------------
oSIST prEN ISO 10993-1:2007
ISO/DIS 10993-1
Introduction
The primary aim of this part of ISO 10993 is the protection of humans from potential biological risks arising
from the use of medical devices. It is compiled from numerous International and National Standards and
Guidelines concerning the biological evaluation of medical devices. It is intended to be the guidance document
for the biological evaluation of medical devices within a risk management process, as part of the overall
evaluation and development of each device. This approach combines the review and evaluation of existing
data from all sources with, where necessary, the selection and application of additional tests, thus enabling a
full evaluation to be made of the biological responses to each medical device, relevant to its safety in use. It
must be appreciated that the term “medical device” is wide-ranging and does, at one extreme, consist of a
single material, which may exist in more than one physical form, and at the other extreme, of a complex
instrument or piece of apparatus, consisting of numerous components made of more than one material.
This international standard addresses the determination of the effects of medical devices on tissues, mostly in
a general way, rather than in a specific device-type situation. Thus, for a complete biological safety evaluation,
it classifies medical devices according to the nature and duration of their anticipated contact with human
tissues when in use and indicates, in matrices, the biological data sets that are thought to be relevant in the
consideration of each device category.
The range of biological hazards is wide and complex. The tissue interaction with a constituent material alone
cannot be considered in isolation from the overall device design. Thus, in designing a device, the choice of the
best material with respect to its tissue interaction might result in a less functional device, tissue interaction
being only one of a number of characteristics to be considered in making that choice. Where a material is
intended to interact with tissue in order to perform its function, the biological evaluation needs to address this.
Tissue interactions that are regarded as adverse caused by a material in one application might not be
regarded so in a different situation. Biological testing is based upon, among other things, in vitro and ex vivo
test methods and upon animal models, so that the anticipated behaviour when a device is used in humans
can be adjudged only with caution, as it cannot be unequivocally concluded that the same tissue reactions will
also occur in this species. In addition, differences in the manner of response to the same material among
individuals indicate that some patients can have adverse reactions, even to well-established materials.
The role of this part of ISO 10993 is to serve as a framework in which to plan a biological evaluation which, as
scientific knowledge advances our understanding of the basic mechanisms of tissue responses, minimizes the
number and exposure of test animals by giving preference to chemical constituent testing and in vitro models,
in situations where these methods yield equally relevant information to that obtained from in vivo models.
It is not intended that this international standard will provide a rigid set of test methods, including pass/fail
criteria, as this might result in either an unnecessary constraint on the development and use of novel medical
devices, or a false sense of security in the general use of medical devices. Where a particular application
warrants it, experts in the product or in the area of application concerned can choose to establish specific
tests and criteria, described in a product-specific vertical standard.
This part of ISO 10993 is intended for use by professionals, appropriately qualified by training and experience,
who are able to interpret its requirements and judge the outcomes of the evaluation for each medical device,
taking into consideration all the factors relevant to the device, its intended use and the current knowledge of
the medical device provided by review of the scientific literature and previous clinical experience.
Annex A contains an informative table which is generally helpful in identifying biological data sets
recommended in the evaluation of medical devices, according to their category of body contact and duration
of clinical exposure. Annex B contains guidance for the application of the risk management process to medical
devices which encompasses biological evaluation.
vi © ISO 2006 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 10993-1:2007
DRAFT INTERNATIONAL STANDARD ISO/DIS 10993-1
Biological evaluation of medical devices —
Part 1:
Evaluation and testing within a risk management system
1 Scope
This part of ISO 10993 describes:
⎯ the general principles governing the biological evaluation of medical devices within a risk management
framework;
⎯ the general categorization of 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 analyze the biological safety of the medical device;
⎯ the assessment of the biological safety of the medical device.
This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect
contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other
parts of ISO 10993 cover specific tests as indicated in the foreword.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only
the edition cited applies. For undated references, the latest edition of the referenced document (including any
amendments) applies.
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and
reproductive toxicity
ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interaction with blood
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-9, Biological evaluation of medical devices — Part 9: Framework for identification and
quantification of potential degradation products
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and delayed–type
hypersensitivity
© ISO 2006 – All rights reserved 1
---------------------- Page: 11 ----------------------
oSIST prEN ISO 10993-1:2007
ISO/DIS 10993-1
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-12, Biological evaluation of medical devices — Part 12: Sample preparation and reference
materials
ISO 10993-13, Biological evaluation of medical devices — Part 13: Identification and quantification of
degradation products from polymeric medical device
ISO 10993-14, Biological evaluation of medical devices — Part 14: Identification and quantification of
degradation products from ceramics
ISO 10993-15, Biological evaluation of medical devices — Part 15: Identification and quantification of
degradation products from metals and alloys
ISO 10993-16, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation
products and leachables
ISO 10993-17, Biological evaluation of medical devices—Part 17: Establishment of allowable limits for
leachable substances
ISO 10993-18, Biological evaluation of medical devices—Part 18: Chemical characterization of materials
ISO/TS 10993-19, Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and
topographical characterization of materials
ISO TS 10993-20, Biological evaluation of medical devices — Part 20: Principles and methods for
immunotoxicology testing of medical devices
ISO 14971, Medical Devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this part of ISO 10993, the following terms and definitions apply.
3.1
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article, intended by the manufacturer to be used, alone or in combination,
for human beings for one or more of the specific purpose(s) of:
⎯ diagnosis, prevention, monitoring, treatment or alleviation of disease,
⎯ diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
⎯ Investigation, replacement, modification, or support of the anatomy or of a physiological process,
⎯ supporting or sustaining life,
⎯ control of conception,
⎯ disinfection of medical devices,
providing information for medical purposes by means of in vitro examination of specimens derived from the
human body, and which does not achieve its primary intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
2 © ISO 2006 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 10993-1:2007
ISO/DIS 10993-1
NOTE 1 This definition has been developed by the Global Harmonization Task Force (GHTF). See bibliographic
reference [5]. [ISO 13485:2003, definition 3.7]
NOTE 2 Products, which may be considered to be medical devices in some jurisdictions but for which there is not yet a
harmonized approach, are:
1) aids for disabled/handicapped people,
2) devices for the treatment/diagnosis of diseases and injuries in animals,
3) accessories for medical devices (see Note 4),
4) disinfection substances,
5) devices incorporating animal and human tissues which may meet the requirements of the above
definition but are subject to different controls.
NOTE 3 Accessories intended specifically by manufacturers to be used together with a ‘parent’ medical device to
enable that medical device to achieve its intended purpose, should be subject to this international standard.
NOTE 4 Medical devices are different from drugs/biologics, and their biological evaluation requires a different approach.
NOTE 5 Medical devices may include dental devices.
3.2
material
any synthetic or natural polymer, metal, alloy, ceramic, or other nonviable substance, including tissue
rendered nonviable, used as a medical device or any part thereof
3.3
final product
medical device in its "as-used"' state, as defined by the manufacturer's specification or labelling
3.4
chemical constituent
any synthetic or natural substance that is used in a process for manufacturing materials and/or medical
devices, such as additives (antioxidants, UV stabilizers, dyestuff, etc.), processing aids (solvents, lubricants,
antifoaming agents, etc.)
3.5
data set
information from a variety of sources necessary to characterise the biological response of a device.
4 General principles applying to biological evaluation of medical devices
4.1 The selection and evaluation of any material or medical device intended for use in humans shall form part
of a structured biological evaluation programme, as set out in Figure 1, within a risk management process.
Annex B, which is based on ISO 14971, provides guidance on this process. The biological evaluation shall be
planned, carried out, and documented by knowledgeable and experienced individuals.
The risk management plan shall identify aspects of the biological evaluation requiring specific technical
competencies and shall identify the person(s) responsible for biological safety evaluation.
The evaluation programme shall include documented informed decisions that assess the
advantages/disadvantages and relevance of:
a) the physical and chemical characteristics of the various candidate materials;
© ISO 2006 – All rights reserved 3
---------------------- Page: 13 ----------------------
oSIST prEN ISO 10993-1:2007
ISO/DIS 10993-1
b) any history of clinical use or human exposure data;
c) any existing toxicology and other biological safety data on product and component materials, breakdown
products and metabolites;
d) test procedures.
Evaluation may include both a study of relevant preclinical and clinical experience and actual testing. Such an
evaluation might result in the conclusion that no testing is needed if the material has a demonstrable safe
history of use in a specified role and physical form that is equivalent to that of the device under design.
4.2 In the selection of materials to be used in device manufacture, the first consideration shall be fitness for
purpose with regard
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.