SS-EN-ISO-10993-11 › Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
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ISO 10993-11:2017 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.
To find similar documents by classification:
11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
Active implantable medical devices. Medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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Designation Name
SS-EN ISO 10993-11:2018
Revision Level
2018 EDITION
Status
Current
Publication Date
June 5, 2018
Language(s)
English
Page Count
52
International Equivalent
EN ISO 10993-11:2018(IDT); ISO 10993-11:2017(IDT)