prEN ISO 10993-1

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
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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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 .
...