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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 28 March 2024. Database contains 4821 unique substances/entries.
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210-013-5
602-01-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
209-128-3
556-52-5
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-440-3
106-90-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
203-441-9
106-91-2
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; STOT RE 1; Eye Dam. 1; Skin Corr. 1C; Skin Sens. 1
218-645-3
2210-79-9
Muta. 2; Skin Irrit. 2; Skin Sens. 1
-
130014-35-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
221-221-0
3033-77-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
208-395-3
526-75-0
Acute Tox. 3; Skin Corr. 1B
276-245-4
71975-58-1
Acute Tox. 3; Skin Corr. 1B
275-732-9
71629-74-8
Acute Tox. 3; STOT RE 2
CLARITONE
422-520-0
74338-72-0
Skin Irrit. 2
239-714-4
15646-96-5
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
203-486-4
107-39-1
Flam. Liq. 2
246-690-9
25167-70-8
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
202-273-3
93-76-5
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-467-8
95-95-4
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
205-282-0
137-17-7
Carc. 1B; Acute Tox. 3
-
21436-97-5
Carc. 1B; Acute Tox. 3
203-600-2
108-62-3
Flam. Sol. 2; Repr. 2; Acute Tox. 3
T3P
422-210-5
68957-94-8
Skin Corr. 1B
423-560-1
161717-32-4
Skin Sens. 1
203-614-9
108-77-0
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
201-795-9
88-06-2
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
204-639-8
123-63-7
Flam. Liq. 3
ESACURE TZT 100
403-150-9
954-16-5
Acute Tox. 4; Eye Irrit. 2

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