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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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246-347-3
24602-86-6
Repr. 1B; Acute Tox. 4; Skin Irrit. 2
DYNASILAN BH N; DYNASILAN BSM 100 N; DYNASILAN NH 42
402-810-3
17980-47-1
Skin Irrit. 2
201-114-5
78-40-0
Acute Tox. 4
204-469-4
121-44-8
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
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-
Acute Tox. 2; Acute Tox. 1
215-812-2
1420-06-0
Acute Tox. 4
604-237-6
141517-21-7
Lact.; Skin Sens. 1
614-708-8
68694-11-1
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
200-929-3
76-05-1
Acute Tox. 4; Skin Corr. 1A
219-014-5
2314-97-8
Muta. 2

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