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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 21 May 2024. Database contains 4753 unique substances/entries.
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215-239-8
1314-62-1
Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3
214-620-6
1166-52-5
Skin Sens. 1
205-570-6
142-90-5
STOT SE 3
216-474-9
1593-77-7
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
BAE; BENZOYLACRYLATE D'ETHYLE; BENZOYLACRYLATE D'ÉTHYLE (TRANS); BENZOYLACRYLIC ACID ETHYL ESTER; BENZOYLACRYLSÄURE ETHYLESTER
408-040-4
15121-89-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
241-178-1
17109-49-8
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
204-079-4
115-29-7
Acute Tox. 2; Acute Tox. 4
205-660-5
145-73-3
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
204-959-8
129-67-9
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
406-850-2
133855-98-8
Carc. 2; Repr. 1B
-
136-25-4
Acute Tox. 4
620-440-2
12510-42-8
Carc. 1A
203-473-3
107-21-1
Acute Tox. 4
240-718-3
16672-87-0
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1C
214-984-6
1239-45-8
Muta. 2; Acute Tox. 2; Acute Tox. 4
204-121-1
116-01-8
Acute Tox. 4
236-152-1
13194-48-4
Acute Tox. 2; Acute Tox. 1; Acute Tox. 3; Skin Sens. 1
429-680-0
122665-86-5
Skin Sens. 1
430-220-6
141942-85-0
Eye Irrit. 2
HOE 70542
401-290-5
103112-35-2
Carc. 1B
DM-8
405-880-3
100501-62-0
Skin Sens. 1
GABAPENTINE ETHYL ESTER; PD 137016
415-970-4
133481-10-4
Acute Tox. 4; STOT RE 2
429-220-9
132584-17-9
Skin Sens. 1
SB-201999
415-680-8
143468-96-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
443-870-0
163520-33-0
Acute Tox. 4; Skin Sens. 1
6,8-DICHLORETHYLCAPRYLAT; ETHYL-6,8 DICHLORO OCTANOATE
435-080-1
1070-64-0
Skin Sens. 1
422-360-1
100491-29-0
Skin Sens. 1
205-500-4
141-78-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
205-438-8
140-88-5
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
203-290-9
105-36-2
Acute Tox. 2; Acute Tox. 1
203-294-0
105-39-5
Acute Tox. 3
203-721-0
109-94-4
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
203-722-6
109-95-5
Flam. Gas 1; Press. Gas; Acute Tox. 4
203-291-4
105-37-3
Flam. Liq. 2
EAPOXC
421-790-7
13014-29-4
Water-react. 1; Skin Corr. 1A
BETA-DAASE; BETA-DIMETHYLAMIMO ACRYLIC ACID ETHYLESTER
402-650-4
1117-37-9
Skin Sens. 1
202-849-4
100-41-4
Flam. Liq. 2; Acute Tox. 4; STOT RE 2; Asp. Tox. 1
203-468-6
107-15-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
Z-2
400-520-1
164907-74-8
Skin Corr. 1B; Acute Tox. 4
205-793-9
151-56-4
Flam. Liq. 2; Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 1; Skin Corr. 1B
Residue from the distillation of dephenolated and debased methylnaphthalene oil (from bituminous coal tar and pyrolysis residual oils) with a boiling range of 240°C to 260°C (464°F to 500°F). Composed primarily of substituted dinuclear aromatic and heterocyclic hydrocarbons.
310-171-6
122070-80-8
Carc. 1B; Muta. 1B
A neutral oil obtained by debasing and dephenolating the oil obtained from the distillation of high temperature tar and pyrolysis residual oils which has a boiliing range of 225°C to 255°C (437°F to 491°F). Composed primarily of substituted dinuclear aromatic hydrocarbons.
310-170-0
122070-79-5
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by the redistillation of the distillate of high temperature coal tar (tar acid and tar base free). It consists predominantly of unsubstituted and substituted mononuclear aromatic hydrocarbons boiling in the range of 85°C-195°C (185°F-383°F).
309-868-8
101316-63-6
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons from the base-free fraction from the distillation of coal tar, boiling in the range of approximately 250°C to 280°C (482°F to 536°F). It consists predominantly of biphenyl and isomeric dimethylnaphthalenes.
310-189-4
122384-77-4
Carc. 1B
309-867-2
101316-62-5
Carc. 1B; Muta. 1B
The residue from low temperature coal tar oils after an alkaline wash, such as aqueous sodium hydroxide, to remove crude coal tar acids. Composed primarily of hydrocarbons and aromatic nitrogen bases.
310-191-5
122384-78-5
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons remaining after the removal of naphthalene from alkali-washed naphthalene oil by a crystallization process. It is composed primarily of naphthalene and alkyl naphthalenes.
310-167-4
121620-48-2
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained from the alkali washing of naphthalene oil to remove phenolic compounds (tar acids). It is composed of naphthalene and alkyl naphthalenes.
310-166-9
121620-47-1
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillate treated with activated charcoal to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-672-2
100684-02-4
Carc. 1B
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillates treated with bleaching earth to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-673-8
100684-03-5
Carc. 1B

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