EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 23 srpnja 2024. Database contains 4821 unique substances/entries.
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434-820-9
106461-41-0
STOT RE 2
ADK ARKLS SV-3
419-090-1
129205-19-2
Skin Sens. 1
CG 27-145
411-220-5
134701-20-5
Skin Irrit. 2; Skin Sens. 1
209-649-6
589-43-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-294-7
565-80-0
Flam. Liq. 2; Acute Tox. 4
203-548-0
108-08-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
202-553-5
97-02-9
Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-087-7
51-28-5
Acute Tox. 3; Acute Tox. 2; STOT RE 1
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
203-321-6
105-67-9
Acute Tox. 3; Skin Corr. 1B

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