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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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212-737-7
865-34-9
Self-heat. 1; Skin Corr. 1B
249-644-6
29457-72-5
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
A complex combination of hydrocarbons having carbon numbers predominantly in the range of C12 through C50. May contain organic salts of alkali metals, alkaline earth metals, and/or aluminium compounds.
278-011-7
74869-21-9
Carc. 1B
A complex combination of hydrocarbons obtained by refining of crude oil. It consists predominantly of aromatics, naphthenics and paraffinics and produces a finished oil with a viscosity of 120 SUS at 100°F (23cSt at 40°C).
297-474-6
93572-43-1
Carc. 1B
A complex combination of hydrocarbons obtained by treating light vacuum gas oil and heavy vacuum gas oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of approximately 15cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-737-9
72623-86-0
Carc. 1B
295-423-2
92045-42-6
Carc. 1B
A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil, and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of approximately 112cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-736-3
72623-85-9
Carc. 1B
A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of approximately 32cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-738-4
72623-87-1
Carc. 1B
295-424-8
92045-43-7
Carc. 1B
A complex combination of hydrocarbons obtained from solvent extraction and dewaxing processes. It consists predominantly of saturated hydrocarbons having carbon numbers in the range C15 through C50.
278-012-2
74869-22-0
Carc. 1B
202-987-5
101-90-6
Carc. 1B; Muta. 2; Acute Tox. 3; Acute Tox. 4; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
203-577-9
108-39-4
Acute Tox. 3; Skin Corr. 1B
202-729-1
99-09-2
Acute Tox. 3; STOT RE 2
203-584-7
108-45-2
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
208-790-0
541-69-5
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
203-583-1
108-44-1
Acute Tox. 3; STOT RE 2
247-722-4
26471-62-5
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
203-576-3
108-38-3
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
241-022-2
16949-65-8
Acute Tox. 3
235-023-7
12057-74-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
231-104-6
7439-95-4
Water-react. 1; Pyr. Sol. 1
231-104-6
7439-95-4
Flam. Sol. 1; Water-react. 2; Self-heat. 1
209-322-8
569-64-2
Repr. 2; Acute Tox. 4; Eye Dam. 1
219-441-7
2437-29-8
Repr. 2; Acute Tox. 4; Eye Dam. 1
204-497-7
121-75-5
Acute Tox. 4; Skin Sens. 1
203-742-5
110-16-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
203-571-6
108-31-6
Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1A
203-703-2
109-77-3
Acute Tox. 3
235-654-8
12427-38-2
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
215-202-6
1313-13-9
Acute Tox. 4
232-089-9
7785-87-7
STOT RE 2
239-924-6
15825-70-4
Unst. Expl.
239-924-6
15825-70-4
Expl. 1.1
202-360-6
94-74-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
246-831-4
25319-90-8
Acute Tox. 4
219-993-9
2595-54-2
Acute Tox. 3
221-106-5
3006-10-8
Skin Corr. 1; Eye Dam. 1
240-539-0
16484-77-8
Acute Tox. 4; Eye Dam. 1
205-275-2
137-05-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
219-634-6
2487-01-6
Acute Tox. 3; Acute Tox. 4
277-543-7
73581-79-0
Eye Irrit. 2; Skin Irrit. 2
204-987-0
130-37-0
Eye Irrit. 2; Skin Irrit. 2
201-123-4
78-57-9
Acute Tox. 4
213-447-3
950-10-7
Acute Tox. 1; Acute Tox. 2
205-769-8
150-76-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
217-991-2
2032-65-7
Acute Tox. 3
231-106-7
7439-97-6
Repr. 1B; Acute Tox. 2; STOT RE 1
231-299-8
7487-94-7
Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1; Skin Corr. 1B
211-057-8
628-86-4
Expl. 1.1; Acute Tox. 3; STOT RE 2
211-057-8
628-86-4
Unst. Expl.; Acute Tox. 3; STOT RE 2

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