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EVS-EN ISO 10993-11:2018

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

General information

Valid from 18.06.2018
Base Documents
ISO 10993-11:2017; EN ISO 10993-11:2018
ICS Groups
11.100.20 Biological evaluation of medical devices
Directives or regulations
None

Standard history

Status
Date
Type
Name
18.06.2018
Main
EVS-EN ISO 10993-11:2018
07.08.2009
Main
EVS-EN ISO 10993-11:2009

ISO 10993-11 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. Systemic toxicity is a potential adverse effect of the use of medical devices. Generalized effects, as well as organ and organ system effects, can result from the absorption, distribution, and metabolism of leachates from the device or its materials to parts of the body with which they are not in direct contact.

Because of the broad range of medical devices, and their materials and intended uses, ISO 10993-11 is not overly prescriptive. While it addresses specific methodological aspects to be considered in the design of systemic toxicity tests, proper study design must be uniquely tailored to the nature of the device’s materials and its intended clinical application. Toxicology is an imperfect science. The outcome of any single test should not be the sole basis for deciding of whether a device is safe for its intended use.

The text of ISO 10993-11:2017 has been approved in Europe as EN ISO 10993-11:2018 without any changes.

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English (PDF 442 KB)

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EVS-EN ISO 10993-18:2020

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EVS-EN ISO 10993-5:2009

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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