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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 June 2024. Database contains 4753 unique substances/entries.
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A complex combination obtained by the fractionation of products from the fluidized catalytic cracker and gas oil desulfurizer. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
273-269-7
68955-33-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by the distillation of products from a steam cracking process. It consists predominantly of propylene with some propane and boils in the range of approximately minus 70°C to 0°C (minus 94°F to 32°F).
295-404-9
92045-22-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and the fractionation of the total effluent. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.
273-270-2
68955-34-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and fractionation of the total effluent. It consists of methane, ethane, and propane.
272-882-7
68919-09-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the fractionation of the liquid from the first tower used in the distillation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
272-883-2
68919-10-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained by the fractionation of reduced crude oil. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
272-884-8
68919-11-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination produced by distillation of products from a thermal cracking process. It consists of hydrogen, hydrogen sulfide, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-789-6
68478-05-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A combination of hydrogen and methane obtained by fractionation of the products from the unifiner unit.
272-885-3
68919-12-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists of hydrocarbons having a carbon number predominantly of C4.
273-265-5
68955-28-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by the fractionation of the charge to the C3-C4 splitter. It consists predominantly of C3 hydrocarbons.
272-893-7
68919-20-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by the atmospheric distillation of a butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C4.
270-769-7
68477-87-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex high octane combination of hydrocarbons obtained by the catalytic dehydrogenation of a predominantly naphthenic naphtha. It consists predominantly of aromatics and non-aromatics having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 45°C to 185°C (113°F to 365°F).
297-458-9
93572-29-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons separated from natural gas by processes such as refrigeration or absorption. It consists predominantly of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C8 and boiling in the range of approximately minus 20°C to 120°C (-4°F to 248°F).
232-349-1
8006-61-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from the fractionation of depropanizer bottoms. It consists of hydrocarbons having carbon numbers predominantly greater than C5.
271-726-5
68606-10-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced from the topping plant by the distillation of crude oil. It boils in the range of approximately 36.1°C to 193.3°C (97°F to 380°F).
271-727-0
68606-11-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons separated from the gases from vapor recovery systems by cooling. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately -20°C to 196°C(-4°F to 384°F).
271-025-4
68514-15-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons consisting primarily of paraffins, cycloparaffins, aromatic and olefinic hydrocarbons having carbon numbers predominantly greater than C3 and boiling in the range of 30°C to 260°C (86°F to 500°F).
289-220-8
86290-81-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
203-377-1
106-24-1
Skin Sens. 1
232-589-7
9001-22-3
Resp. Sens. 1
278-636-5
77182-82-2
Repr. 1B; Acute Tox. 4; STOT RE 2
203-856-5
111-30-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A
200-240-8
55-63-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-240-8
55-63-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
203-474-9
107-22-2
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
206-058-5
298-12-4
Eye Dam. 1; Skin Sens. 1B
213-997-4
1071-83-6
Eye Dam. 1
219-468-4
2439-99-8
Eye Dam. 1
201-964-7
90-05-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
200-002-3
50-01-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
218-165-4
2058-94-8
yes
200-962-3
76-44-8
Carc. 2; Acute Tox. 3; STOT RE 2
213-831-0
1024-57-3
Carc. 2; Acute Tox. 3; STOT RE 2
206-803-4
376-06-7
yes
203-767-1
110-43-0
Flam. Liq. 3; Acute Tox. 4
203-388-1
106-35-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2
204-608-9
123-19-3
Flam. Liq. 3; Acute Tox. 4
205-563-8
142-82-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
203-838-7
111-14-8
Skin Corr. 1B
245-737-0
23560-59-0
Acute Tox. 3
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Hexabromocyclododecane EC / List no: 247-148-4 | CAS no: 25637-99-4
1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
beta-hexabromocyclododecane EC / List no: 603-802-4 | CAS no: 134237-51-7
alpha-hexabromocyclododecane EC / List no: 603-801-9 | CAS no: 134237-50-6
247-148-4
25637-99-4
Repr. 2; Lact.
yes
204-129-5
116-16-5
Acute Tox. 4
204-273-9
118-74-1
Carc. 1B; STOT RE 1
201-029-3
77-47-4
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
241-010-7
16941-12-1
Acute Tox. 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
204-127-4
116-15-4
Press. Gas; Acute Tox. 4; STOT SE 3
256-356-4
48122-14-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
260-566-1
57110-29-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
235-921-9
13048-33-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1

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