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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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208-778-5
541-41-3
Flam. Liq. 2; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
428-030-3
67914-69-6
Acute Tox. 4; STOT RE 2
203-721-0
109-94-4
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
275-897-7
71720-48-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
202-598-0
97-64-3
Flam. Liq. 3; STOT SE 3; Eye Dam. 1
202-597-5
97-63-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
611-089-6
540-67-0
Flam. Gas 1; Press. Gas
244-845-5
22212-55-1
Acute Tox. 4
434-630-6
60372-77-2
Eye Dam. 1
210-903-3
625-58-1
Unst. Expl.
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
ET 344 SP
412-540-8
22471-55-2
Skin Irrit. 2
BETA-DAASE; BETA-DIMETHYLAMIMO ACRYLIC ACID ETHYLESTER
402-650-4
1117-37-9
Skin Sens. 1
MCDPAE
406-580-5
52460-86-3
Skin Irrit. 2
200-834-7
75-04-7
Flam. Gas 1; Press. Gas; Eye Irrit. 2; STOT SE 3
202-849-4
100-41-4
Flam. Liq. 2; Acute Tox. 4; STOT RE 2; Asp. Tox. 1
209-940-8
598-56-1
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
200-815-3
74-85-1
Flam. Gas 1; Press. Gas; STOT SE 3
219-732-9
2514-53-6
Skin Irrit. 2
202-617-2
97-90-5
STOT SE 3; Skin Sens. 1
211-063-0
628-96-6
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-849-9
75-21-8
Press. Gas; Flam. Gas 1; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 3; STOT SE 3; STOT RE 1; Skin Corr. 1; Eye Dam. 1
202-506-9
96-45-7
Repr. 1B; Acute Tox. 4
yes
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
425-430-1
6746-94-7
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
ETHOFENPROX; TREBON
407-980-2
80844-07-1
Lact.
219-991-8
2593-15-9
Carc. 2; Acute Tox. 4; Skin Sens. 1
253-855-9
38260-54-7
Acute Tox. 4
CINEOLE ALCOHOL
402-470-6
87172-89-2
Acute Tox. 4; Eye Dam. 1
The extract oil boiling in the range of approximately 220°C to 265°C (428°F to 509°F) from coal tar alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove tar bases. Composed primarily of alkylnaphthalenes.
284-901-6
84989-12-8
Carc. 1B; Muta. 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
The redistillate from the fractional distillation of dephenolated and debased methylnaphthalene oil obtained from bituminous coal high temperature tar and pyrolysis residual oils boiling in the approximate range of 220°C to 230°C (428°F to 446°F). It consists predominantly of unsubstituted and substituted dinuclear aromatic hydrocarbons.
295-329-1
91995-66-3
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
The aqueous extract produced by an acidic wash of alkali-washed carbolic oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.
292-622-6
90640-99-6
Carc. 1B; Muta. 1B
The aqueous extract produced by an acidic wash of alkali-washed napthalene oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.
292-623-1
90641-00-2
Carc. 1B; Muta. 1B
The extract produced by the acidic extraction of bases from crude coal tar aromatic oils, neutralization, and distillation of the bases. Composed primarily of collidines, aniline, toluidines, lutidines, xylidines.
273-077-3
68937-63-3
Carc. 1B; Muta. 1B
The extract from coal tar oil alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove naphthalene. Composed primarily of the acid salts of various aromatic nitrogen bases including pyridine, quinoline, and their alkyl derivatives.
266-020-9
65996-86-3
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
An acid sludge by-product of the sulphuric acid refining of crude high temperature coal. Composed primarily of sulfuric acid and organic compounds.
298-725-2
93821-38-6
Carc. 1B; Muta. 1B
The redistillate from the distillate, freed of tar acids and tar bases, from bituminous coal high temperature tar boiling in the approximate range of 90°C to 160°C (194°F to 320°F). It consists predominantly of benzene, toluene and xylenes.
295-323-9
91995-61-8
Carc. 1B; Muta. 1B
The residue from toluene extraction of dried brown coal.
294-285-0
91697-23-3
Carc. 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 oil resulting from the acid washing of alkali-washed carbolic oil to remove the minor amounts of basic compounds (tar bases). Composed primarily of indene, indan and alkylbenzenes.
292-624-7
90641-01-3
Carc. 1B; Muta. 1B
The first fraction from the distillation of aromatic hydrocarbons, coumarone, naphthalene and indene rich prefractionator bottoms or washed carbolic oil boiling substantially below 145°C (293°F). Composed primarily of C7 and C8 aliphatic and aromatic hydrocarbons.
292-625-2
90641-02-4
Carc. 1B; Muta. 1B
The distillate from aromatic hydrocarbons, coumarone, naphthalene and indene rich prefractionator bottoms or washed carbolic oils, having an approximate boiling range of 155°C to 180°C (311°F to 356°F). Composed primarily of indene, indan and trimethylbenzenes.
292-626-8
90641-03-5
Carc. 1B; Muta. 1B

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