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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 04 listopada 2024. Database contains 4821 unique substances/entries.
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SCARLET PE 3948
424-260-3
784157-49-9
Repr. 2; Eye Dam. 1
442-230-8
321679-52-1
Eye Dam. 1
248-743-1
27942-27-4
yes
219-682-8
2497-59-8
yes
604-395-6
14409-72-4
yes
247-816-5
26571-11-9
yes
GLYOXYLATE DE MENTHYLE HYDRATÉ; MENTHYL GLYOXYLATE HYDRATE
416-810-6
111969-64-3
STOT RE 2; Eye Dam. 1
COUPLER II; UC-136
406-200-8
117827-06-2
Skin Sens. 1
A1354
411-970-3
79881-89-3
Acute Tox. 4; STOT RE 2
BTA-A; FLUTAMIDE BTA-A
406-740-4
1939-27-1
STOT RE 2
BASIC RED FC 48215
406-055-0
124584-00-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
440-770-9
371921-63-0
Eye Dam. 1
202-109-0
91-94-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
204-355-4
119-90-4
Carc. 1B; Acute Tox. 4
200-261-2
56-18-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
439-500-2
33831-83-3
Acute Tox. 4; Skin Irrit. 2
209-243-9
563-16-6
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-230-8
562-49-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
431-500-0
226065-73-2
Skin Sens. 1
219-374-3
2426-02-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
202-448-4
95-76-1
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
441-810-8
116313-85-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
429-130-1
2820-37-3
Acute Tox. 4; Eye Dam. 1
209-504-7
583-48-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-415-3
577-71-9
Acute Tox. 3; STOT RE 2

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