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prEN ISO 10993-16

Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables (ISO/DIS 10993-16:2025)

Draft New
Comment end date 2026-02-17
Export comments Read draft and comment

Project stage codes

1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas
2. Projektas
3. Viešoji apklausa
From 2025-12-19 till 2026-02-17
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

2025-12-19

Scope

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic evaluation relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic evaluation in the biological evaluation of medical devices.

Relations

Pakeis
LST EN ISO 10993-16:2018