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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 May 2024. Database contains 4753 unique substances/entries.
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231-959-5
7782-50-5
Ox. Gas 1; Press. Gas; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
SILAN MCS
410-270-5
770722-46-8
Skin Corr. 1A
201-178-4
79-11-8
Acute Tox. 3; Skin Corr. 1B
201-171-6
79-04-9
Acute Tox. 3; STOT RE 1; Skin Corr. 1A
200-830-5
75-00-3
Flam. Gas 1; Press. Gas; Carc. 2
200-817-4
74-87-3
Flam. Gas 1; Press. Gas; Carc. 2; STOT RE 2
232-234-6
7790-94-5
Skin Corr. 1A; STOT SE 3
231-801-5
7738-94-5
yes
279-116-0
79234-33-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
278-290-5
75660-25-2
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
422-660-2
7480-35-5
Eye Dam. 1; Skin Sens. 1
231-187-9
7443-70-1
Acute Tox. 4
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
231-842-9
7758-89-6
Acute Tox. 4
231-159-6
7440-50-8
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
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
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
231-720-5
7700-17-6
Acute Tox. 3
200-847-8
75-19-4
Flam. Gas 1; Press. Gas
200-923-0
75-99-0
Skin Irrit. 2; Eye Dam. 1
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
-
74195-78-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
231-786-5
7727-54-0
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
200-824-2
74-95-3
Acute Tox. 4
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
DBB
401-040-5
75113-37-0
Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
SILAN DCS
407-180-3
770722-36-6
Skin Corr. 1A
201-207-0
79-43-6
Skin Corr. 1A
201-199-9
79-36-7
Skin Corr. 1A
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
200-838-9
75-09-2
Carc. 2
620-436-0
75736-33-3
Eye Irrit. 2
230-525-2
7173-51-5
Acute Tox. 4; Skin Corr. 1B
274-460-8
70225-14-8
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
425-380-9
7397-46-8
Pyr. Liq. 1; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
200-760-5
71-63-6
Acute Tox. 3; STOT RE 2
276-090-2
71850-09-4
Repr. 1B
yes
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
201-208-6
79-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-901-0
75-78-5
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
212-039-2
753-73-1
Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1B
617-485-5
76714-88-0
Acute Tox. 4
201-107-7
78-34-2
Acute Tox. 2; Acute Tox. 3
427-300-8
79463-77-7
Eye Dam. 1
278-355-8
75980-60-8
Repr. 2
231-781-8
7727-21-1
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1

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