iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN ISO 10993-10:2023

(Main)

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
—    details of in vivo skin sensitization test procedures;
—    key factors for the interpretation of the results.
NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfungen auf Hautsensibilisierung (ISO 10993-10:2021)

Dieses Dokument legt das Verfahren für die Beurteilung von Medizinprodukten und ihren Bestandteilen hinsichtlich ihres Potentials, eine Hautsensibilisierung auszulösen, fest.
Dieses Dokument enthält:
   Einzelheiten zur Durchführung von In-vivo-Hautsensibilisierungsprüfungen;
   Schlüsselfaktoren für die Interpretation der Ergebnisse.
ANMERKUNG   Anhang A enthält Anweisungen für die spezielle Vorbereitung von Materialien im Zusammenhang mit den vorstehend angeführten Prüfungen.

Évaluation biologique des dispositifs médicaux - Partie 10: Essais de sensibilisation cutanée (ISO 10993-10:2021)

Le présent document spécifie le mode opératoire pour l'évaluation du potentiel des dispositifs médicaux et de leurs matériaux constitutifs à provoquer une sensibilisation cutanée.
Le présent document comprend:
—    des informations détaillées relatives aux modes opératoires d'essai de sensibilisation cutanée in vivo;
—    les facteurs clés pour l'interprétation des résultats.
NOTE      Des instructions pour la préparation des matériaux spécifiquement pour les essais ci-dessus sont données dans l'Annexe A.

Biološko ovrednotenje medicinskih pripomočkov - 10. del: Preskusi preobčutljivosti kože (ISO 10993-10:2021)

Ta dokument določa postopek za presojo medicinskih pripomočkov in njihovih sestavnih materialov glede potenciala za povzročitev preobčutljivosti kože.
Dokument vsebuje:
– podrobnosti preskusnih postopkov za preobčutljivost kože;
– ključne dejavnike za razlago rezultatov.
OPOMBA      Navodila za pripravo materialov posebej za zgoraj navedene preskuse so podana v dodatku A.

General Information

Status
Published
Publication Date
07-Feb-2023
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
08-Feb-2023
Completion Date
08-Feb-2023
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
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
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 10993-10:2023 - Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

Relations

Replaces
EN ISO 10993-10:2013 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Effective Date
22-Feb-2023
Replaces
EN ISO 10993-10:2010 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Effective Date
19-Jan-2023

Buy Standard

EN ISO 10993-10:2023EN ISO 10993-10:2023
PreviousNext
Standard
EN ISO 10993-10:2023
English language
60 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-10:2023
01-maj-2023
Nadomešča:
SIST EN ISO 10993-10:2013
Biološko ovrednotenje medicinskih pripomočkov - 10. del: Preskusi
preobčutljivosti kože (ISO 10993-10:2021)
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993
-10:2021)
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfungen auf
Hautsensibilisierung (ISO 10993-10:2021)
Évaluation biologique des dispositifs médicaux - Partie 10: Essais de sensibilisation
cutanée (ISO 10993-10:2021)
Ta slovenski standard je istoveten z: EN ISO 10993-10:2023
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
SIST EN ISO 10993-10:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 10993-10:2023

---------------------- Page: 2 ----------------------
SIST EN ISO 10993-10:2023


EN ISO 10993-10
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2023
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-10:2010
English Version

Biological evaluation of medical devices - Part 10: Tests for
skin sensitization (ISO 10993-10:2021)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil
10: Essais de sensibilisation cutanée (ISO 10993- 10: Prüfungen auf Hautsensibilisierung (ISO 10993-
10:2021) 10:2021)
This European Standard was approved by CEN on 13 September 2021.

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, Türkiye and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-10:2023 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 10993-10:2023
EN ISO 10993-10:2023 (E)
Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European standard and the General
Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be
covered. 4

2

---------------------- Page: 4 ----------------------
SIST EN ISO 10993-10:2023
EN ISO 10993-10:2023 (E)
European foreword
This document (EN ISO 10993-10:2023) 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 August 2023, and conflicting national standards shall
be withdrawn at the latest by August 2023.
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 10993-10:2010.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s) / Regulation(s).
For the relationship with EU Directive(s) / Regulation(s), see informative Annex ZA, which is an integral
part of this document.
Any feedback and questions on this document should be directed to the users’ national standards
bo
...

Questions, Comments and Discussion

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

This May Also Interest You

CEN
EN ISO 10993-17:2023(Main)
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
SIST EN ISO 10993-17:2024

This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1.
The process described in this document applies to chemical characterization information obtained in line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable.
The process described in this document is not intended to apply to circumstances where the toxicological risk has been estimated by other means, such as:
—    constituents, excluding cohort of concern or excluded chemicals, that are present in or extracted from a medical device at an amount representative of patient exposure below a relevant, toxicologically-based reporting threshold (see applicable requirements in ISO 10993-18:2020, Annex E and ISO/TS 21726);
—    a new or changed medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device (see applicable requirements in ISO 10993-18:2020, Annex C).
The process described in this document is also not applicable to:
—    medical device constituents that do not contact the body (e.g. in vitro diagnostics);
—    biological risks associated with physical interactions of the medical device with the body (i.e. application of mechanical forces, energy or surface morphology, etc.), provided that the chemical exposure is not changed;
—    active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations can apply;
—    exposure to a particular constituent that arises from sources other than the device, such as food, water or air.

  • Standard
    78 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 10993-18:2020/A1:2023(Amendment)
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)
SIST EN ISO 10993-18:2020/A1:2023
  • Amendment
    13 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 10993-15:2023(Main)
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
SIST EN ISO 10993-15:2023

NEXT ACTION: TC ACTION BY 2022-10-26 : TC to send a revised annex ZA for assessment at PUB
2020-02-19- JO-CEN/TC 206 to take decision either to remove the link or send a revised annex ZA for assessment at PUB

  • Standard
    26 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 10993-2:2022(Main)
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
SIST EN ISO 10993-2:2023

This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.
This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.
This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.
This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.

  • Standard
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 10993-7:2008/A1:2022(Amendment)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
SIST EN ISO 10993-7:2009/A1:2022

2021-12-09- JO-  the EN was submitted to FV wiith the link to the legislation (90/385/EEC, 93/42/EEC)
however since these legilsations have been repealed, the link has been removed and the EN is to proceed to publication

  • Amendment
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 10993-9:2021(Main)
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
SIST EN ISO 10993-9:2022

This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.
This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.
This document is not applicable to:
a)   the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available;
NOTE    Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993.
b)   leachable components which are not degradation products;
c)   medical devices or components that do not contact the patient's body directly or indirectly.

  • Standard
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 10993-12:2021(Main)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
SIST EN ISO 10993-12:2021

This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.
Specifically, this document addresses the following:
—     test sample selection;
—     selection of representative portions from a medical device;
—     test sample preparation;
—     experimental controls;
—     selection of, and requirements for, reference materials;
—     preparation of extracts.
This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.
Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.

  • Standard
    32 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 10993-23:2021(Main)
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
SIST EN ISO 10993-23:2021

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.
This document includes:
—     pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
—     details of in vitro and in vivo irritation test procedures;
—     key factors for the interpretation of the results.

  • Standard
    76 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 10993-1:2020(Main)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
SIST EN ISO 10993-1:2021

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.

  • Standard
    50 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 22442-1:2020(Main)
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
SIST EN ISO 22442-1:2021

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:
a)   contamination by bacteria, moulds or yeasts;
b)   contamination by viruses;
c)   contamination by agents causing transmissible spongiform encephalopathies (TSE);
d)   material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This document does not specify a quality management system for the control of all stages of production of medical devices.
This document does not cover the utilization of human tissues in medical devices.
NOTE 1  It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
NOTE 2  For guidance on the application of this document, see Annex A.

  • Standard
    37 pages
    English language
    sale 10% off
    e-Library read for
    1 day