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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 20 lipnja 2024. Database contains 4821 unique substances/entries.
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401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
245-986-5
24017-47-8
Acute Tox. 3; Acute Tox. 4
-
26766-27-8
Acute Tox. 4
432-270-4
221354-37-6
Repr. 2; STOT RE 2
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
-
-
Pyr. Liq. 1; Skin Corr. 1B
259-537-6
55219-65-3
Repr. 1B; Lact.; Acute Tox. 4
256-103-8
43121-43-3
Acute Tox. 4; Skin Sens. 1
200-875-0
75-50-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-875-0
75-50-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
218-962-7
2303-17-5
Acute Tox. 4; STOT RE 2; Skin Sens. 1
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-
B Bacteria and similar species
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-
B Bacteria and similar species
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-
B Bacteria and similar species
-
-
B Bacteria and similar species
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
405-060-5
118712-89-3
Skin Irrit. 2
443-150-6
101226-85-1
Flam. Liq. 3
250-517-2
31218-83-4
Acute Tox. 3
205-860-2
156-60-5
Flam. Liq. 2; Acute Tox. 4
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
231-186-3
7443-52-9
Acute Tox. 4
DHP OPT
445-770-2
42031-28-7
Eye Dam. 1

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