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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 17 May 2024. Database contains 4753 unique substances/entries.
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A complex combination of hydrocarbons obtained during the sorptions of toluene from a hydrocarbon fraction from cracked gasoline treated with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C8 and boiling in the range of approximately 80°C to 135°C (176°F to 275°F).
309-870-9
101316-66-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation of hydrotreated naphtha followed by solvent extraction. It consists predominantly of saturated hydrocarbons and boiling in the range of approximately 65°C to 70°C (149°F to 158°F).
309-871-4
101316-67-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of nonaromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 120°C to 210°C (248°F to 380°F) and C9 and higher aromatic hydrocarbons.
297-465-7
93572-35-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation from prehydrogenated cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C11 and boiling in the range of approximately 130°C to 205°C (266°F to 401°F).
295-444-7
92045-62-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation of products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C12 and boiling in the range of approximately 140°C to 210°C (284°F to 410°F).
309-974-4
101794-97-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
309-987-5
101896-28-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of a cut from the catalytic cracking process, having undergone an alkaline washing. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130°C to 210°C (266°F to 410°F).
295-794-0
92128-94-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-853-6
93763-34-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-854-1
93763-35-0
Asp. Tox. 1
270-690-8
68476-50-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
297-857-8
93763-38-3
Carc. 1B
A combination of hydrocarbons obtained from the distillation of hydrotreated naphtha followed by a solvent extraction and distillation process. It consists predominantly of saturated hydrocarbons boiling in the range of approximately 94°C to 99°C (201°F to 210°F).
295-436-3
92045-55-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
231-595-7
7647-01-0
Skin Corr. 1B; STOT SE 3
231-595-7
7647-01-0
Press. Gas; Acute Tox. 3; Skin Corr. 1A
231-634-8
7664-39-3
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1A
231-634-8
7664-39-3
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1A
215-605-7
1333-74-0
Flam. Gas 1; Press. Gas
200-821-6
74-90-8
Flam. Liq. 1; Acute Tox. 2
200-821-6
74-90-8
Acute Tox. 2; Acute Tox. 1
231-765-0
7722-84-1
Ox. Liq. 1; Acute Tox. 4; Skin Corr. 1A
2-BUTANEDIOIC ACID, MONOAMIDE WITH N-(9-OCTADECENYL)-3-AMINO
402-970-4
148292-42-6
Skin Sens. 1
231-977-3
7783-06-4
Flam. Gas 1; Press. Gas; Acute Tox. 2
SICORIN E 10197
403-750-0
113036-91-2
Acute Tox. 4
423-310-1
61420-92-6
Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
641-410-5
130066-44-3
Skin Sens. 1A
232-259-2
7803-49-8
Unst. Expl.; Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
232-259-2
7803-49-8
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
258-872-5
53933-48-5
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
242-818-2
19098-16-9
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
244-077-0
20845-01-6
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
226-798-2
5470-11-1
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
233-154-4
10046-00-1
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
236-691-2
13465-08-2
Expl. 1.1; Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
DP-3337
405-710-8
23783-26-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
-
-
P Parasites
-
-
P Parasites
233-000-6
10004-44-1
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
200-090-3
51-34-3
Acute Tox. 2; Acute Tox. 1
202-933-0
101-31-5
Acute Tox. 2
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
252-615-0
35554-44-0
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Dam. 1
261-351-5
58594-72-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
261-351-5
58594-72-2
Acute Tox. 4; Skin Sens. 1
617-219-8
81334-34-1
Eye Irrit. 2
428-040-8
138261-41-3
Acute Tox. 4
431-510-5
18087-70-2
Acute Tox. 4; Eye Irrit. 2
206-019-2
288-32-4
Repr. 1B; Acute Tox. 4; Skin Corr. 1C
428-790-6
72963-72-5
Carc. 2; Acute Tox. 4; STOT SE 2
244-959-5
22398-80-7
Carc. 1B; Repr. 2; STOT RE 1
605-683-4
173584-44-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B

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