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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 listopada 2024. Database contains 4821 unique substances/entries.
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231-768-7
7723-14-0
Flam. Sol. 1
FCC 963
410-880-1
147170-38-5
Acute Tox. 4; Skin Corr. 1B
MP-2000; MP-2000X
406-620-1
129217-90-9
Skin Sens. 1
ORGANOTUNGSTEN COMPOUND CONCENTRATE
408-250-6
121754-49-2
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
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-
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
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-
Carc. 1B; Muta. 2; Acute Tox. 4; Acute Tox. 3; STOT RE 2; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
432-440-8
220444-73-5
Carc. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
426-860-0
191877-09-5
Eye Dam. 1
939-460-0
1471311-26-8
yes
500-033-5
25068-38-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1

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