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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 11 listopada 2024. Database contains 4821 unique substances/entries.
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205-592-6
143-22-6
Eye Dam. 1
P-964
420-580-2
151798-26-4
Repr. 1B
687-832-3
1119449-37-4
yes
204-709-8
124-68-5
Eye Irrit. 2; Skin Irrit. 2
ACIDE CÉBRANILIQUE
424-700-4
150812-32-1
Eye Dam. 1
415-500-8
145963-84-4
Acute Tox. 4; STOT RE 2
205-483-3
141-43-5
Acute Tox. 4; Skin Corr. 1B
203-541-2
108-00-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
DAM 520
413-440-7
112006-75-4
Skin Sens. 1
CG 25-369; IRGACURE 369; TK 11-319
404-360-3
119313-12-1
Repr. 1B
yes

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