EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1

Active Implantable Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This non-exhaustive database 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Last updated 24 June 2024. Database contains 4753 unique substances/entries.
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269-511-6
68259-08-5
yes
249-415-0
29081-56-9
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
232-989-1
9080-17-5
Skin Corr. 1B
221-037-0
2980-64-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
223-320-4
3825-26-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
232-565-6
9000-90-2
Resp. Sens. 1
202-910-5
101-05-3
Eye Irrit. 2; Skin Irrit. 2
200-539-3
62-53-3
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
204-371-1
120-12-7
yes
A complex combination of hydrocarbons from the base-freed fraction obtained from the distillation of coal tar and boiling in the range of approximately 325°C to 365°C (617°F to 689°F). It contains predominantly anthracene and phenanthrene and their alkyl derivatives.
295-274-3
91995-14-1
Carc. 1B
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 coal high temperature tar and boiling in the approximate range of 350°C to 360°C (662°F to 680°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-276-4
91995-16-3
Carc. 1B; Muta. 1B
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
201-549-0
84-65-1
Carc. 1B
231-601-8
7647-18-9
Skin Corr. 1B
233-047-2
10025-91-9
Skin Corr. 1B
232-009-2
7783-56-4
Acute Tox. 3
215-175-0
1309-64-4
Carc. 2
201-706-3
86-88-4
Acute Tox. 2; Carc. 2
268-618-5
68131-49-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
292-697-5
90989-41-6
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816°C (1500°F) of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8, including benzene.
270-658-3
68475-70-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 (primarily C8) and can contain nonaromatic hydrocarbons, both boiling in the range of approximately 130°C to 200°C (266°F to 392°F).
297-401-8
93571-75-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
292-698-0
90989-42-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
295-279-0
91995-18-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
292-695-4
90989-39-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from the evaporation of solvent under vacuum from polymerized hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C9 and boiling in the range of approximately 120°C to 215°C (248°F to 419°F).
295-281-1
91995-20-9
Carc. 1B; Muta. 1B
292-694-9
90989-38-1
Carc. 1B; Muta. 1B
295-551-9
92062-36-7
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons produced by the distillation of the products from a steam cracking process treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly greater than C10 and boiling in the range of approximately 150°C to 320°C (302°F to 608°F).
292-621-0
90640-98-5
Asp. Tox. 1
231-148-6
7440-38-2
Acute Tox. 3
231-901-9
7778-39-4
Carc. 1A; Acute Tox. 3
yes
232-066-3
7784-42-1
Flam. Gas 1; Press. Gas; Acute Tox. 2; STOT RE 2
217-617-8
1912-24-9
STOT RE 2; Skin Sens. 1
200-104-8
51-55-8
Acute Tox. 2
265-610-3
65195-55-3
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
262-102-3
60207-31-0
Acute Tox. 4
220-147-6
2642-71-9
Acute Tox. 2; Acute Tox. 3
201-676-1
86-50-0
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
203-102-5
103-33-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2
255-209-1
41083-11-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
227-419-3
5834-96-8
Acute Tox. 4
207-802-1
495-48-7
Acute Tox. 4
202-930-4
101-27-9
Acute Tox. 4; Skin Sens. 1
208-167-3
513-77-9
Acute Tox. 4
236-760-7
13477-00-4
Ox. Sol. 1; Acute Tox. 4
233-788-1
10361-37-2
Acute Tox. 3; Acute Tox. 4

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