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EVS-EN ISO 10993-1:2020

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

General information

Valid from 31.12.2020
Base Documents
ISO 10993-1:2018; EN ISO 10993-1:2020
ICS Groups
11.100.20 Biological evaluation of medical devices
Directives or regulations
None

Standard history

Status
Date
Type
Name
Main
prEN ISO 10993-1
31.12.2020
Main
EVS-EN ISO 10993-1:2020
03.02.2011
Main
EVS-EN ISO 10993-1:2011
06.09.2010
Corrigendum
EVS-EN ISO 10993-1:2009/AC:2010

The primary aim of ISO 10993-1 is the protection of humans from potential biological risks arising from the use of medical devices. The primary role is to serve as a framework in which to plan a biological evaluation.  ISO 10993-1 applies to the evaluation of materials and medical devices that are expected to have direct or indirect contact with the patient's body or the user’s body (e.g., surgical gloves, masks).

This standard specifies:

— the general principles governing the biological evaluation of medical devices,
— the general categorization of medical devices,
— the assessment of the biological safety of the medical device.

It applies to the biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. ISO 10993-1 also gives guidelines for the assessment of biological hazards arising from risks, such as changes to the medical device over time, or 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.

The text of ISO 10993-1:2018 has been approved in Europe as EN ISO 10993-1:2020 without any changes.

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Standard monitoring
English (PDF 534 KB) Estonian (PDF 265 KB)

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Main

EVS-EN ISO 14155:2020

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Valid from 02.10.2020
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EVS-EN ISO 10993-18:2020

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Valid from 15.06.2020
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EVS-EN ISO 10993-10:2023

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
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EVS-EN ISO 10993-23:2021

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Newest version Valid from 15.04.2021

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English