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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
234-239-9
11005-63-3
Acute Tox. 3; STOT RE 2
202-851-5
100-42-5
Flam. Liq. 3; Repr. 2; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
203-570-0
108-30-5
Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
204-482-5
121-57-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
234-129-0
10545-99-0
Skin Corr. 1B; STOT SE 3
-
13451-08-6
Skin Corr. 1B
626-360-4
15244-35-6
yes
An acidified alkaline extract of brown coal tar distillate. Composed primarily of phenol and phenol homologs.
309-888-7
101316-86-3
Carc. 1B; Muta. 1B
An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one- to three-ring aromatic hydrocarbons, their alkyl derivatives, heteroaromatics and one- and two-ring phenols boiling in the range of approximately 150°C to 360°C (302°F to 680°F).
309-885-0
101316-83-0
Carc. 1A
A distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160°C to 340°C (320°F to 644°F).
309-889-2
101316-87-4
Carc. 1B; Muta. 1B
A tar obtained from low temperature carbonization and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.
309-886-6
101316-84-1
Carc. 1A
Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatized compounds and mineral substances.
309-726-5
100684-51-3
Carc. 1B
Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300°C (572°F). Composed primarily of aromatic compounds.
309-887-1
101316-85-2
Carc. 1B
600-363-0
102851-06-9
Acute Tox. 4; Skin Irrit. 2
TEBUCONAZOLE RESP. HWG 1608
403-640-2
107534-96-3
Repr. 2; Acute Tox. 4
601-585-0
119168-77-3
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1B
204-178-2
117-18-0
Acute Tox. 4; Skin Sens. 1
203-495-3
107-49-3
Acute Tox. 1; Acute Tox. 2
604-715-4
149979-41-9
Carc. 2; Repr. 2
235-963-8
13071-79-9
Acute Tox. 1; Acute Tox. 2
429-170-8
134575-17-0
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
216-768-7
1663-39-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
216-653-1
1634-04-4
Flam. Liq. 2; Skin Irrit. 2
MJR-580
418-520-5
183130-96-3
Eye Irrit. 2
C.I. DIRECT BLUE 301; DIRECT BLUE 301
408-210-8
124605-82-9
Skin Sens. 1
425-270-0
134620-00-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
426-730-3
123439-82-7
Acute Tox. 4; Eye Dam. 1
PRO-JET BLACK 286 COLOUR; SUBSTANZ H112286
405-130-5
128351-36-0
Skin Sens. 1
235-541-3
12267-73-1
Repr. 1B
yes
424-710-9
156126-48-6
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
P3B
418-080-4
120307-06-4
Skin Sens. 1
236-669-2
13463-39-3
Flam. Liq. 2; Carc. 2; Repr. 1B; Acute Tox. 2
204-274-4
118-75-2
Eye Irrit. 2; Skin Irrit. 2
204-825-9
127-18-4
Carc. 2
204-171-4
117-08-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
TETRACONAZOLE
407-760-6
112281-77-3
Acute Tox. 4
215-582-3
1333-22-8
Acute Tox. 4
682-362-5
12527-76-3
Acute Tox. 4
215-910-5
1449-55-4
Acute Tox. 4
429-270-1
136210-30-5
Skin Sens. 1
203-726-8
109-99-9
Flam. Liq. 2; Carc. 2; Eye Irrit. 2; STOT SE 3
203-239-0
104-80-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
234-290-7
11070-44-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
203-728-9
110-01-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
204-783-1
126-33-0
Acute Tox. 4
432-770-2
139189-30-3
Skin Sens. 1
SUBSTANCE TP-415; SUBSTANZ TP-415; TP-415
404-760-8
117342-25-3
Acute Tox. 3; Eye Dam. 1
DIRECT YELLOW 86 TETRAMETHYLAMMONIUM SALT; YELLOW DYE FOR PAINTJET PRINT CARTRIDGE
405-950-3
131013-83-7
Acute Tox. 3
FOOD BLACK 2, TETRAMETHYLAMMONIUM SALT
405-170-3
116340-05-7
Acute Tox. 3; Skin Sens. 1

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