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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 svibnja 2024. Database contains 4821 unique substances/entries.
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204-327-1
119-47-1
Repr. 1B
yes
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
219-943-6
2580-56-5
yes
273-688-5
69011-06-9
yes
257-175-3
51404-69-4
yes
201-173-7
79-06-1
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
yes
-
-
yes
287-476-5
85535-84-8
Carc. 2
yes
281-985-6
84082-38-2
yes
307-451-5
97659-46-6
yes
283-930-1
84776-06-7
yes
287-504-6
85536-22-7
yes
701-376-5
1372804-76-6
yes
287-477-0
85535-85-9
Lact.
yes
283-931-7
84776-07-8
yes
285-195-2
85049-26-9
yes
272-924-4
68920-70-7
yes
263-004-3
61788-76-9
yes
603-801-9
134237-50-6
yes
604-314-4
142844-00-6
yes
700-242-3
62037-80-3
yes
232-143-1
7789-09-5
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
221-470-5
3108-42-7
Carc. 2; Repr. 1B; Lact.
yes
269-511-6
68259-08-5
yes
-
4149-60-4
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
223-320-4
3825-26-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
204-371-1
120-12-7
yes
A complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of 330°C to 350°C (626°F to 662°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-275-9
91995-15-2
Carc. 1B; Muta. 1B
yes
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of approximately 290°C to 340°C (554°F to 644°F). It contains chiefly trinuclear aromatics and their dihydro derivatives.
295-278-5
91995-17-4
Carc. 1B; Muta. 1B
yes
The anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.
292-603-2
90640-81-6
Carc. 1B; Muta. 1B
yes
The oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.
292-604-8
90640-82-7
Carc. 1B; Muta. 1B
yes
A complex combination of polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300°C to 400°C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole
292-602-7
90640-80-5
Carc. 1B
yes
231-901-9
7778-39-4
Carc. 1A; Acute Tox. 3
yes
201-622-7
85-68-7
Repr. 1B
yes
200-280-6
56-55-3
Carc. 1B
yes
209-008-0
552-30-7
STOT SE 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
200-028-5
50-32-8
Carc. 1B; Muta. 1B; Repr. 1B; Skin Sens. 1
yes
205-883-8
191-24-2
yes
205-916-6
207-08-9
Carc. 1B
yes
603-802-4
134237-51-7
yes
202-177-1
92-67-1
Carc. 1A; Acute Tox. 4
yes
205-594-7
143-24-8
Repr. 1B
yes
204-211-0
117-81-7
Repr. 1B
yes
203-924-4
111-96-6
Flam. Liq. 3; Repr. 1B
yes
204-212-6
117-82-8
Repr. 1B
yes
214-604-9
1163-19-5
yes
200-268-0
56-35-9
yes
201-245-8
80-05-7
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
yes
-
90568-23-3
yes
-
125022-34-6
yes

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