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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 16 srpnja 2024. Database contains 4821 unique substances/entries.
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436-920-8
172399-10-9
Eye Dam. 1
301-312-2
93983-23-4
Eye Irrit. 2
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
205-391-3
140-01-2
Acute Tox. 4; STOT RE 2
418-270-7
-
Skin Sens. 1
404-290-3
7216-95-7
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
250-378-8
30899-19-5
Flam. Liq. 3; Acute Tox. 4; STOT SE 3
204-634-0
123-54-6
Flam. Liq. 3; Acute Tox. 4
203-692-4
109-66-0
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
202-490-3
96-22-0
Flam. Liq. 2; STOT SE 3
235-067-7
12065-90-6
yes
426-590-3
187412-41-5
Skin Sens. 1
222-540-8
3524-68-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
201-084-3
78-11-5
Unst. Expl.
201-084-3
78-11-5
Expl. 1.1
225-644-1
4986-89-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
276-745-2
72629-94-8
yes
201-778-6
87-86-5
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-925-1
76-01-7
Carc. 2; STOT RE 1
210-172-0
608-93-5
Flam. Sol. 1; Acute Tox. 4
-
-
F Fungi
254-938-2
40487-42-1
Skin Sens. 1
266-275-6
66246-88-6
Repr. 2; Acute Tox. 4
214-215-4
1114-71-2
Acute Tox. 4
-
-
B Bacteria and similar species

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