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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 April 2024. Database contains 4753 unique substances/entries.
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F Fungi
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. 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 at least 100 SUS at 100°F (19cSt at 40°C).
265-174-4
64742-70-7
Carc. 1B
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-176-5
64742-71-8
Carc. 1B
A complex combination of hydrocarbons obtained from sulfur-containing paraffinic crude oil. It consists predominantly of a solvent refined deparaffinated lubricating oil with a viscosity of 65cSt at 50°C.
295-810-6
92129-09-4
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with bentonite for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-297-1
97926-77-7
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with silicic acid for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-298-7
97926-78-8
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with activated carbon for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-296-6
97926-76-6
Carc. 1B
A complex combination of hydrocarbons obtained from liqnite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process treated with hydrogen in the presence of a catalyst. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.
295-455-7
92045-72-2
Carc. 1B
A complex combination of hydrocarbons obtained from liqnite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.
295-454-1
92045-71-1
Carc. 1B
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P Parasites
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
217-615-7
1910-42-5
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
218-196-3
2074-50-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-271-7
56-38-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1
206-050-1
298-00-0
Flam. Liq. 3; Acute Tox. 2; Acute Tox. 3; STOT RE 2
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B Bacteria and similar species
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B Bacteria and similar species
214-215-4
1114-71-2
Acute Tox. 4
266-275-6
66246-88-6
Repr. 2; Acute Tox. 4
254-938-2
40487-42-1
Skin Sens. 1
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F Fungi
210-172-0
608-93-5
Flam. Sol. 1; Acute Tox. 4
200-925-1
76-01-7
Carc. 2; STOT RE 1
201-778-6
87-86-5
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
276-745-2
72629-94-8
yes
225-644-1
4986-89-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
201-084-3
78-11-5
Unst. Expl.
201-084-3
78-11-5
Expl. 1.1
222-540-8
3524-68-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
426-590-3
187412-41-5
Skin Sens. 1
235-067-7
12065-90-6
yes
202-490-3
96-22-0
Flam. Liq. 2; STOT SE 3
203-692-4
109-66-0
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
204-634-0
123-54-6
Flam. Liq. 3; Acute Tox. 4
250-378-8
30899-19-5
Flam. Liq. 3; Acute Tox. 4; STOT SE 3
404-290-3
7216-95-7
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
418-270-7
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Skin Sens. 1
205-391-3
140-01-2
Acute Tox. 4; STOT RE 2
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
301-312-2
93983-23-4
Eye Irrit. 2
436-920-8
172399-10-9
Eye Dam. 1
OLIVE-GREEN JB 1170
419-210-2
178452-71-6
Eye Dam. 1
414-910-4
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Eye Dam. 1; Skin Sens. 1
442-030-0
321912-47-4
Eye Dam. 1
256-418-0
49663-84-5
yes
215-320-8
1321-64-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
211-047-3
628-63-7
Flam. Liq. 3
211-340-6
638-49-3
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
207-332-7
463-04-7
Flam. Liq. 2; Acute Tox. 4
210-852-7
624-54-4
Flam. Liq. 3

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