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prEN ISO 10993-11

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

Draft Public enquiry
Comment end date 2026-07-23
Export comments Read draft and comment

Project stage codes

1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas
2. Projektas
3. Viešoji apklausa
From 2026-05-24 till 2026-07-23
4. Closure of enquiry
5. Submission to Formal Vote

Organisation

CEN Europos standartizacijos komitetas

ICS

11.100.20 - Biological evaluation of medical devices

Technical Committee

TK 32 Health

ForeignTC'S

CEN/TC 206

Number of comments

0

Comment start date

2026-05-24

Scope

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.

Relations

Pakeis
LST EN ISO 10993-11:2018