NBN 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 2018-10)

ACTIVE

About this standard

Languages
German, English and French
Type
NBN
Standards committee
CEN/TC 206
Status
ACTIVE
Publication date
27 January 2021
Replaces
NBN EN ISO 10993-1 (12/2009):2009, NBN EN ISO 10993-1/AC:2010
ICS Code
11.100.20 (Biological evaluation of medical devices)
Withdrawn Date

About this training

Summary

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.