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prEN ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2026)

General information

Draft
Base Documents
ISO/DIS 10993-11; prEN ISO 10993-11
ICS Groups
11.100.20 Biological evaluation of medical devices
Directives or regulations
None
You can view draft standards in the Commenting portal🡭.

Standard history

Status
Date
Type
Name
Main
prEN ISO 10993-11
18.06.2018
Main
EVS-EN ISO 10993-11:2018
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Required fields are indicated with *

*
*
*
Standard monitoring

Related products

Main

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)
Withdrawn from 15.01.2026
Main

EVS-EN ISO 14155:2020

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Withdrawn from 04.05.2026
Main

EVS-EN ISO 10993-1:2026

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)
Newest version Valid from 15.01.2026
Main

EVS-EN ISO 10993-10:2023

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
Newest version Valid from 01.03.2023

Standards designation

EVSEstonian standard
ENEuropean standard (published by an CEN or CENELEC)
EN ISOInternational standard adopted as an European standard
ISOInternational Organization for Standardization’s standard
IECInternational Electrotechnical Commission’s standard
HDCENELEC’s harmonisation document
EVS-ENEuropean standard implemented in Estonia
EVS-EN ISOInternational standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IECInternational standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IECInternational electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
 
A, AMDamedment
+Aa full standard plus the amendment
/Aonly amendment
COR, ACcorrigendum
+CORa full standard plus the corrigendum
NAnational annex
+NAa full standard plus the national annex
/NAonly national annex
TStechnical specification
TRtechnical report
CWAagreement, developed by a CEN or CENELEC
prEVS-EN (etc)draft standard
 
etthe standard is in Estonian only
enthe standard is in English only
et-enthe standard is in Parallel text Estonian-English