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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 07 listopada 2024. Database contains 4821 unique substances/entries.
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CIS/TRANS-TIMO; FLOROL; FLOROSA
405-040-6
63500-71-0
Eye Irrit. 2
THTPA
407-330-8
61571-06-0
Repr. 1B; Eye Dam. 1
428-070-1
91788-83-9
STOT RE 1; Acute Tox. 4
SUBSTANCE TP-415; SUBSTANZ TP-415; TP-415
404-760-8
117342-25-3
Acute Tox. 3; Eye Dam. 1
DIRECT YELLOW 86 TETRAMETHYLAMMONIUM SALT; YELLOW DYE FOR PAINTJET PRINT CARTRIDGE
405-950-3
131013-83-7
Acute Tox. 3
FOOD BLACK 2, TETRAMETHYLAMMONIUM SALT
405-170-3
116340-05-7
Acute Tox. 3; Skin Sens. 1
TP-302
404-860-1
116810-46-9
Flam. Sol. 1; Eye Dam. 1
440-460-3
252579-81-0
Eye Irrit. 2
FOOD BLACK 2, LITHIUM SALT
405-150-4
106028-58-4
Skin Sens. 1
TMAP
416-900-5
79723-02-7
Acute Tox. 3; STOT RE 2

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