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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 18 June 2024. Database contains 4753 unique substances/entries.
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269-855-7
68359-37-5
Acute Tox. 2
642-974-5
400882-07-7
Carc. 2; Skin Sens. 1A
405-230-9
101205-02-1
Repr. 2
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P Parasites
200-847-8
75-19-4
Flam. Gas 1; Press. Gas
CHLOROFORMIATE DE CYCLOPENTYLE; CYCLOPENTYLCHLORFORMIAT
411-460-0
50715-28-1
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
428-340-9
238088-70-5
Skin Irrit. 2
204-435-9
120-92-3
Flam. Liq. 3; Eye Irrit. 2; Skin Irrit. 2
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
206-016-6
287-92-3
Flam. Liq. 2
VIOLIFF
401-620-8
87731-18-8
Skin Sens. 1
220-279-4
2699-11-8
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
220-279-4
2699-11-8
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
CHMMS; CHMS; DYNASYLAN 9407; Z-6187
402-140-1
17865-32-6
Skin Irrit. 2
203-629-0
108-91-8
Flam. Liq. 3; Repr. 2; Acute Tox. 4; Skin Corr. 1B
221-319-3
3066-71-5
STOT SE 3; Skin Irrit. 2
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
235-527-7
12262-58-7
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
235-527-7
12262-58-7
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
203-631-1
108-94-1
Flam. Liq. 3; Acute Tox. 4
203-630-6
108-93-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
203-806-2
110-82-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
431-730-1
4277-06-9
Skin Irrit. 2; Skin Sens. 1
427-230-8
5571-36-8
Repr. 1B; STOT RE 2
CSDCA
419-150-7
113136-77-9
Acute Tox. 4
223-099-4
3734-95-0
Acute Tox. 2; Acute Tox. 3
220-130-3
2636-26-2
Acute Tox. 4
620-377-0
13067-93-1
Acute Tox. 3; STOT SE 1; Acute Tox. 4; Eye Irrit. 2
244-544-9
21725-46-2
Acute Tox. 4
206-992-3
420-04-2
Carc. 2; Repr. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1; Skin Sens. 1; Eye Dam. 1
202-704-5
98-82-8
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3
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P Parasites
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P Parasites
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F Fungi
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F Fungi
206-083-1
299-86-5
Acute Tox. 4
231-720-5
7700-17-6
Acute Tox. 3
224-030-0
4170-30-3
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
208-622-6
535-89-7
Acute Tox. 2
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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.
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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.
The low-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38°C (100°F).
274-566-4
70321-80-1
Carc. 1B
The high-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5°C (41°F).
274-565-9
70321-79-8
Carc. 1B
A complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240°C to 280°C (464°F to 536°F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.
292-605-3
90640-84-9
Carc. 1B
The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.
292-606-9
90640-85-0
Carc. 1B
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200°C to 325°C (392°F to 617°F).
263-047-8
61789-28-4
Carc. 1B
The distillate of coal tar produced by the high temperature carbonization of bituminous coal. It consists primarily of aromatic hydrocarbons, tar acids and tar bases.
232-287-5
8001-58-9
Carc. 1B
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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.
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B Bacteria and similar species

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