oSIST prEN ISO 10993-1:2024

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024)

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: Anforderungen und allgemeine Grundsätze für die Beurteilung der biologischen Sicherheit im Rahmen eines Risikomanagementsystems (ISO/DIS 10993-1:2024)

Évaluation biologique des dispositifs médicaux - Partie 1: Exigences et principes généraux pour l’évaluation de la sécurité biologique au sein d’un processus de gestion des risques (ISO/DIS 10993-1:2024)

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: Zahteve in splošna načela za oceno biološke varnosti znotraj procesa obvladovanja tveganja (ISO/DIS 10993-1:2024)

General Information

• Status: Not Published
• Public Enquiry End Date: 15-Sep-2024
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 11-Jul-2024
• Due Date: 28-Nov-2024
• Directive: 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
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: prEN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024)

Relations

• Revises: SIST EN ISO 10993-1:2021 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)
• Effective Date: 26-Jan-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2024
Biološko ovrednotenje medicinskih pripomočkov - 1. del: Zahteve in splošna
načela za oceno biološke varnosti znotraj procesa obvladovanja tveganja (ISO/DIS
10993-1:2024)
Biological evaluation of medical devices - Part 1: Requirements and general principles
for the evaluation of biological safety within a risk management process (ISO/DIS 10993-
1:2024)
Biologische Beurteilung von Medizinprodukten - Teil 1: Anforderungen und allgemeine
Grundsätze für die Beurteilung der biologischen Sicherheit im Rahmen eines
Risikomanagementsystems (ISO/DIS 10993-1:2024)
Évaluation biologique des dispositifs médicaux - Partie 1: Exigences et principes
généraux pour l’évaluation de la sécurité biologique au sein d’un processus de gestion
des risques (ISO/DIS 10993-1:2024)
Ta slovenski standard je istoveten z: prEN ISO 10993-1
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 10993-1
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 1: 2024-06-24
Requirements and general
Voting terminates on:
2024-09-16
principles for the evaluation of
biological safety within a risk
management process
ICS: 11.100; 11.100.20
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Reference number
ISO/DIS 10993-1:2024(en)
DRAFT
ISO/DIS 10993-1:2024(en)
International
Standard
ISO/DIS 10993-1
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 1:
Requirements and general
Voting terminates on:
principles for the evaluation of
biological safety within a risk
management process
ICS: 11.100; 11.100.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
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Published in Switzerland Reference number
ISO/DIS 10993-1:2024(en)
ii
ISO/DIS 10993-1:2024(en)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General principles . 7
4.1 Biological evaluation within an ISO 14971 risk management framework .7
4.2 Medical device life cycle .9
4.3 Animal welfare .10
5 Biological evaluation process .10
5.1 Overview .10
5.2 Biological evaluation plan .10
6 Biological risk analysis .12
6.1 General approach . 12
6.2 Identification of characteristics related to biological safety . 13
6.3 Identification of biological hazards, biologically hazardous situations, and potential
biological harms .14
6.4 Categorization of medical device and determination of scope of evaluation . 15
6.4.1 General . 15
6.4.2 Exposure duration categories . 15
6.4.3 Calculation of exposure duration for medical devices with daily contact with
tissues .16
6.4.4 Calculation of exposure duration for medical devices with intermittent contact
with tissues .16
6.4.5 Body contact and biological effects for consideration .16
6.5 Identified biological effects for evaluation . 20
6.5.1 Overall approach . 20
6.5.2 totoxicity .21
6.5.3 Sensitisation .21
6.5.4 Irritation .21
6.5.5 Systemic toxicity .21
6.5.6 Local effects after tissue contact . 22
6.5.7 Genotoxicity . 22
6.5.8 Carcinogenicity . 23
6.5.9 Haemocompatibility . 23
6.5.10 Other biological effects. 23
6.5.11 Other Factors to be considered .24
6.6 Gap analysis . 26
6.6.1 General . 26
6.6.2 Medical devices evaluated using previous versions of the standard .27
6.7 Biological equivalence .27
6.8 Testing . 29
6.8.1 General principles . 29
6.8.2 Biological, physical and chemical testing . 30
6.8.3 Degradation testing .31
6.8.4 Toxicokinetic studies .31
6.9 Biological risk estimation .31
7 Biological evaluation .32
8 Biological risk control .33
9 Biological evaluation report . .33
10 Production and post-production activities .33

iii
ISO/DIS 10993-1:2024(en)
Annex A (informative) Material selection and characterisation to support the biological
evaluation of a medical device .35
Annex B (informative) Rationale for key changes in the biological effects listed in Tables 1-4 .38
Annex C (informative) Possible approaches to biological risk estimation .
...