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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 01 December 2023. Database contains 4753 unique substances/entries.
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P Parasites
220-639-0
2844-92-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
240-979-3
16921-30-5
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
231-781-8
7727-21-1
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
215-197-0
1312-73-8
Skin Corr. 1B
233-050-9
10025-99-7
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
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83-59-0
Acute Tox. 3; Acute Tox. 4
203-869-6
111-43-3
Flam. Liq. 2; STOT SE 3
205-565-9
142-84-7
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
201-579-4
85-00-7
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
223-714-6
4032-26-2
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
SÄUREBRAUN 8507
404-930-1
118556-91-5
Acute Tox. 4; Eye Dam. 1
427-310-2
180850-95-7
Eye Dam. 1
REACTIVE BLUE FC 60866
414-040-5
149530-93-8
Acute Tox. 4; Skin Sens. 1
ACID BLUE 344; BLEU ACIDE 344; BLEU ACIDO 344; BLU ACIDO 344; C.I. ACID BLUE 344; SÄURE BLAU 344
400-350-8
85153-93-1
Eye Dam. 1
432-980-4
243858-60-8
Eye Dam. 1
PRODUKT 1096
414-230-8
-
Skin Sens. 1
209-358-4
573-58-0
Carc. 1B; Repr. 2
yes
YELLOW JB 1238
423-110-4
-
Eye Dam. 1
217-710-3
1937-37-7
Carc. 1B; Repr. 2
yes
YELLOW DO 2286
412-530-3
157627-98-0
Eye Dam. 1; Skin Sens. 1
DRIMAREN SCHARLACH X-GA 979; DRIMAREN SCHARLAKEN X-GA; DRIMAREN SCHARLAKEN X-GA 979; DRIMARENE SCARLET X-2 GN; ECARLATE DRIMARENE X-2GN; ECARLATE DRIMARENE X-GA 979; ECARLATE X-GA 979; SCARLET X-GA 979
400-380-1
86393-35-3
Skin Sens. 1
EVERZOL ORANGE GR; ORANGE HF-SNK; REAKTIV ORANGE FD 19969 FW
404-600-7
129009-88-7
Skin Sens. 1
SCARLET X-GA 1491
410-390-8
147703-64-8
Eye Dam. 1
423-730-5
250688-43-8
Eye Dam. 1
9,10-ANTHRACENEDIOL, DISODIUM SALT
426-030-8
46492-07-3
Skin Corr. 1A
240-983-5
16923-58-3
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
229-912-9
6834-92-0
Skin Corr. 1B; STOT SE 3
DIDA
402-360-8
92511-22-3
Eye Dam. 1
234-541-0
12008-41-2;12280-03-4
Repr. 1B
yes
602-894-3
12280-03-4
Repr. 1B
DURALINK (R) HTS; ERP-390
401-320-7
5719-73-3
Skin Sens. 1
215-211-5
1313-82-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
603-411-9
1303-96-4
Repr. 1B
yes
601-808-1
12179-04-3
Repr. 1B
yes
215-540-4
1330-43-4
Repr. 1B
yes
233-051-4
10026-00-3
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
240-221-1
16071-86-6
Carc. 1B
A residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75°C to 200°C (167°F to 392°F).
309-984-9
101896-26-8
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150°C to 300°C (302°F to 572°F) or a semi-solid or solid with a melting point up to 70°C (158°F). It is composed primarily of naphthalene and alkyl naphthalenes.
310-165-3
121620-46-0
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists of hydrocarbons having carbon numbers primarily in the range of C4 to C10 and distilling in the approximate range of 80°C to 160°C (175°F to 320°F).
283-482-7
84650-02-2
Carc. 1B
The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350°C to 400°C (662°F to 752°F). Consists predominantly of tri- and polynuclear aromatics and heterocyclic hydrocarbons.
295-304-5
91995-42-5
Carc. 1B
Distillate from the fractional distillation of coal tar of bituminous coal, with boiling range of 240°C to 400°C (464°F to 752°F). Composed primarily of tri- and polynuclear hydrocarbons and heterocyclic compounds.
292-607-4
90640-86-1
Carc. 1B
This oil is a complex mixture of aromatic hydrocarbons, primarily indene, naphthalene, coumarone, phenol, and o-, m-, and p-cresol and boiling in the range of 140°C to 215°C (284°F to 419°F).
292-609-5
90640-87-2
Carc. 1B; Muta. 1B
The aqueous extract from carbolic oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
292-610-0
90640-88-3
Carc. 1B; Muta. 1B
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135°C to 210°C (275°F to 410°F). May also include unsaturated hydrocarbons such as indene and coumarone.
309-971-8
101794-90-5
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by distillation of coal tar. It consists of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills at the approximate range of 150°C to 210°C (302°F to 410°F).
283-483-2
84650-03-3
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by crystallization of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.
284-898-1
84989-09-3
Carc. 1B; Muta. 1B
A complex combination of organic compounds obtained as a filtrate from the crystallization of the naphthalene fraction from coal tar and boiling in the range of approximately 200°C to 230°C (392°F to 446°F). Contains chiefly naphthalene, thionaphthene and alkylnaphthalenes.
295-310-8
91995-49-2
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by debasing the methylnaphthalene fraction obtained by the distillation of coal tar and boiling in the range of approximately 230°C to 255°C (446°F to 491°F). Contains chiefly 1(2)-methylnaphthalene, naphthalene, dimethylnaphthalene and biphenyl.
295-309-2
91995-48-1
Carc. 1B; Muta. 1B

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