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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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443-120-2
393509-79-0
Eye Dam. 1
442-960-7
332350-93-3
Acute Tox. 3; Eye Dam. 1
442-860-3
87333-22-0
Skin Sens. 1
442-850-9
114772-40-6
Skin Sens. 1
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
442-800-6
-
Skin Irrit. 2
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
442-480-8
-
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
442-300-8
-
Skin Sens. 1
442-290-5
457624-86-1
Eye Dam. 1
442-230-8
321679-52-1
Eye Dam. 1
442-030-0
321912-47-4
Eye Dam. 1
441-810-8
116313-85-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
441-550-5
-
Self-react. C; Carc. 2
HPDCFA
441-190-9
121451-05-6
Acute Tox. 4; Skin Sens. 1
441-070-6
61826-76-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
441-000-4
121219-07-6
Acute Tox. 4
440-770-9
371921-63-0
Eye Dam. 1
440-620-2
920-36-5
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A; STOT SE 3
440-510-4
-
Eye Dam. 1; Skin Sens. 1
440-480-2
341026-59-3
Eye Dam. 1; Skin Sens. 1
440-460-3
252579-81-0
Eye Irrit. 2
440-030-5
338735-71-0
Skin Irrit. 2; Eye Dam. 1
439-540-0
-
Skin Irrit. 2; Skin Sens. 1

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