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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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A complex combination of hydrocarbons obtained as a semi-solid from dewaxing paraffinic residual oil. It consists predominantly of saturated crystalline and liquid hydrocarbons having carbon numbers predominantly greater than C25.
232-373-2
8009-03-8
Carc. 1B
A complex combination of hydrocarbons obtained by subjecting a liquified petroleum gas mix to a sweetening process to oxidize mercaptans or to remove acidic impurities. It consists predominantly of C4 saturated and unsaturated hydrocarbons.
295-463-0
92045-80-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by subjecting liquefied petroleum gas mix to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40°C to 80°C (-40°F to 176°F).
270-705-8
68476-86-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40°C to 80°C (-40°F to 176°F).
270-704-2
68476-85-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
The complex combination of hydrocarbons obtained in a hydrofiner-powerformer process and boiling in a range of approximately 27°C to 210°C (80°F to 410°F).
271-058-4
68514-79-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination which consists primarily of hydrogen with various small amounts of methane, ethane, and propane.
271-750-6
68607-11-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons. It consists predominantly of aliphatic, alicyclic and aromatic hydrocarbons. It may also contain small amounts of nitrogen, oxygen and sulfur compounds. This category encompasses light, medium, and heavy petroleums, as well as the oils extracted from tar sands. Hydrocarbonaceous materials requiring major chemical changes for their recovery or conversion to petroleum refinery feedstocks such as crude shale oils, upgraded shale oils and liquid coal fuels are not included in this definition.
232-298-5
8002-05-9
Carc. 1B
201-581-5
85-01-8
yes
Residue from the distillation of crude phenanthrene boiling in the approximate range of 340°C to 420°C (644°F to 788°F). It consists predominantly of phenanthrene, anthracene and carbazole.
310-169-5
122070-78-4
Carc. 1B
218-892-7
2275-14-1
Acute Tox. 3
616-100-8
74499-35-7
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
701-105-0
1801269-80-6
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
701-107-1
1801269-77-1
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
640-104-9
210555-94-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
608-492-4
3050-88-2
yes
310-154-3
121158-58-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
276-743-1
72624-02-3
yes
291-844-0
90481-04-2
yes
203-632-7
108-95-2
Muta. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1B
201-004-7
77-09-8
Carc. 1B; Muta. 2; Repr. 2
yes
The combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700°C (1292°F)) destructive distillation of coal. It consists predominantly of a mixture of monohydric and dihydric phenols.
284-881-9
84988-93-2
Carc. 1B; Muta. 1B
293-435-2
91079-47-9
Carc. 1B; Muta. 1B
219-997-0
2597-03-7
Acute Tox. 4
CGI 819
423-340-5
162881-26-7
Skin Sens. 1A
204-557-2
122-60-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
DPX-E6758
406-600-2
89392-03-0
Skin Sens. 1
202-873-5
100-63-0
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
248-259-0
27140-08-5
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
200-444-7
59-88-1
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
257-622-2
52033-74-6
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
200-532-5
62-38-4
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
202-866-7
100-57-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
200-242-9
55-68-5
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
206-052-2
298-02-2
Acute Tox. 1; Acute Tox. 2
223-874-7
4104-14-7
Acute Tox. 1; Acute Tox. 2
218-996-2
2310-17-0
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
213-423-2
947-02-4
Acute Tox. 1; Acute Tox. 2
200-870-3
75-44-5
Press. Gas; Acute Tox. 2; Skin Corr. 1B
211-987-4
732-11-6
Repr. 2; Acute Tox. 4; Acute Tox. 3; STOT SE 1
-
5826-76-6
Acute Tox. 4
236-116-5
13171-21-6
Muta. 2; Acute Tox. 2; Acute Tox. 3
232-260-8
7803-51-2
Flam. Gas 1; Press. Gas; Acute Tox. 1; Skin Corr. 1B
237-066-7
13598-36-2
Acute Tox. 4; Skin Corr. 1A
231-633-2
7664-38-2
Skin Corr. 1B
-
17169-61-8
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
233-663-1
10294-56-1
Acute Tox. 4; Skin Corr. 1A
233-060-3
10026-13-8
Acute Tox. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
215-236-1
1314-56-3
Skin Corr. 1A
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
231-749-3
7719-12-2
Acute Tox. 2; STOT RE 2; Skin Corr. 1A

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