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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 02 listopada 2024. Database contains 4821 unique substances/entries.
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260-515-3
57018-04-9
Skin Sens. 1B
203-625-9
108-88-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
265-697-8
65321-67-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
208-741-3
540-25-0
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
208-740-8
540-23-8
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
211-986-9
731-27-1
Acute Tox. 2; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
211-986-9
731-27-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
204-854-7
127-65-1
Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1
618-075-9
87820-88-0
Carc. 2; Acute Tox. 4
FC4010
417-290-3
147086-81-5
Acute Tox. 4

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