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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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232-627-2
9001-73-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
616-379-6
76738-62-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
203-396-5
106-42-3
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
UP 565
411-530-0
15024-10-9
Skin Sens. 1
203-403-1
106-49-0
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
203-180-0
104-15-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-180-0
104-15-4
Skin Corr. 1B
203-404-7
106-50-3
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
203-199-4
104-40-5
yes
202-810-1
100-01-6
Acute Tox. 3; STOT RE 2
202-795-1
99-86-5
Flam. Liq. 3; Acute Tox. 4; Skin Sens. 1; Asp. Tox. 1
247-770-6
26543-97-5
yes
203-398-6
106-44-5
Acute Tox. 3; Skin Corr. 1B
203-405-2
106-51-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-254-2
104-94-9
Acute Tox. 2; Acute Tox. 1; STOT RE 2
241-427-4
17404-66-9
yes
201-280-9
80-46-6
yes
250-339-5
30784-30-6
yes
231-956-9
7782-44-7
Ox. Gas 1; Press. Gas
219-679-1
2497-07-6
Acute Tox. 2; Acute Tox. 3
211-745-8
693-21-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
211-745-8
693-21-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
203-430-9
106-75-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
206-110-7
301-12-2
Acute Tox. 3
226-066-2
5259-88-1
Acute Tox. 4

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