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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
213-608-8
993-16-8
Repr. 2
680-302-2
95266-40-3
STOT RE 2; Skin Sens. 1B
ACID BLUE 349; AZO-METALCOMPLEX-BLUE AP 1149; BLEU ACIDE 349; C.I. ACID BLUE 349; SELLASET BLEU H; SELLASET BLUE H
402-870-0
93952-24-0
Eye Dam. 1
232-650-8
9002-07-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
424-390-0
93280-40-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1
The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.
295-549-8
92062-34-5
Carc. 1B
202-634-5
98-07-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
202-635-0
98-08-8
Flam. Liq. 2

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