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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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.

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Last updated 23 April 2024. Database contains 4753 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
2,4,4-trimethylhexamethylene-1,6-di-isocyanate
239-714-4
15646-96-5
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
2,4,4-trimethylpent-1-ene
203-486-4
107-39-1
Flam. Liq. 2
2,4,4-trimethylpentene
246-690-9
25167-70-8
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
2,4,5-T (ISO); 2,4,5-trichlorophenoxy acetic acid
202-273-3
93-76-5
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2,4,5-trichlorophenol
202-467-8
95-95-4
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2,4,5-trimethylaniline
205-282-0
137-17-7
Carc. 1B; Acute Tox. 3
2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane; metaldehyde
203-600-2
108-62-3
Flam. Sol. 2; Repr. 2; Acute Tox. 3
2,4,6-trichloro-1,3,5-triazine; cyanuric chloride
203-614-9
108-77-0
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2,4,6-trichlorophenol
201-795-9
88-06-2
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2,4,6-trimethyl-1,3,5-trioxane; paraldehyde
204-639-8
123-63-7
Flam. Liq. 3
2,4,6-trinitro-m-cresol
210-027-1
602-99-3
Expl. 1.1; Acute Tox. 4
2,4,6-trinitro-m-xylene
211-187-5
632-92-8
Expl. 1.1; Acute Tox. 4; STOT RE 2
2,4,6-trinitrophenol; picric acid
201-865-9
88-89-1
Expl. 1.1; Acute Tox. 3
2,4,6-trinitroresorcinol; styphnic acid
201-436-6
82-71-3
Expl. 1.1; Acute Tox. 4
2,4,6-trinitrotoluene; TNT
204-289-6
118-96-7
Expl. 1.1; Acute Tox. 3; STOT RE 2
2,4,6-tris(dimethylaminomethyl)phenol
202-013-9
90-72-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2,4-D (ISO); 2,4-dichlorophenoxyacetic acid
202-361-1
94-75-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1; Skin Sens. 1
2,4-DB (ISO); 4-(2,4-dichlorophenoxy)butyric acid
202-366-9
94-82-6
Acute Tox. 4
2,4-Di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol; UV-327
223-383-8
3864-99-1
yes
2,4-diamino-3,5-diethyltoluene; 2,4-diethyl-6-methyl-1,3-benzenediamine
218-256-9
2095-02-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,4-diaminoanisole sulphate
254-323-9
39156-41-7
Carc. 1B; Muta. 2; Acute Tox. 4
2,4-diaminoanisole; 4-methoxy-m-phenylenediamine
210-406-1
615-05-4
Carc. 1B; Muta. 2; Acute Tox. 4
2,4-dichlorophenol
204-429-6
120-83-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
2,4-dimethylhexane
209-649-6
589-43-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,4-dimethylpentan-3-one; di-isopropyl ketone
209-294-7
565-80-0
Flam. Liq. 2; Acute Tox. 4
2,4-dimethylpentane
203-548-0
108-08-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,4-dinitroaniline
202-553-5
97-02-9
Acute Tox. 2; Acute Tox. 1; STOT RE 2
2,4-dinitrophenol
200-087-7
51-28-5
Acute Tox. 3; Acute Tox. 2; STOT RE 1
2,4-dinitrotoluene
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
2,4-xylenol
203-321-6
105-67-9
Acute Tox. 3; Skin Corr. 1B
2,5-dimethylhexane
209-745-8
592-13-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,5-dinitrophenol
206-348-1
329-71-5
Acute Tox. 3; STOT RE 2
2,5-dinitrotoluene
210-581-4
619-15-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
2,5-xylenol
202-461-5
95-87-4
Acute Tox. 3; Skin Corr. 1B
2,6-diamino-3,5-diethyltoluene; 4,6-diethyl-2-methyl-1,3-benzenediamine
218-255-3
2095-01-4
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,6-diethylaniline
209-445-7
579-66-8
Acute Tox. 4
2,6-dimethylheptan-4-one; di-isobutyl ketone
203-620-1
108-83-8
Flam. Liq. 3; STOT SE 3
2,6-dinitrophenol
209-357-9
573-56-8
Acute Tox. 3; STOT RE 2
2,6-dinitrotoluene
210-106-0
606-20-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
2,6-xylenol
209-400-1
576-26-1
Acute Tox. 3; Skin Corr. 1B
2,6-xylidine; 2,6-dimethylaniline
201-758-7
87-62-7
Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
2-(2-aminoethylamino)ethanol; (AEEA)
203-867-5
111-41-1
Repr. 1B; Skin Corr. 1B; Skin Sens. 1
2-(2-butoxyethoxy)ethanol; diethylene glycol monobutyl ether
203-961-6
112-34-5
Eye Irrit. 2
2-(2-butoxyethoxy)ethyl thiocyanate
203-985-7
112-56-1
Flam. Liq. 3; Acute Tox. 3
2-(2-hexyloxyethoxy)ethanol; DEGHE; diethylene glycol monohexyl ether; 3,6-dioxa-1-dodecanol; hexyl carbitol; 3,6-dioxadodecan-1-ol
203-988-3
112-59-4
Acute Tox. 4; Eye Dam. 1
2-(2-methoxyethoxy)ethanol; diethylene glycol monomethyl ether
203-906-6
111-77-3
Repr. 2
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol; UV-328
247-384-8
25973-55-1
yes
2-(2H-Benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol; UV-350
253-037-1
36437-37-3
yes
2-(3,4-dichlorophenyl)-4-methyl-1,2,4-oxadiazolidinedione; methazole
243-761-6
20354-26-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2-(4-chloro-2-methylphenoxy)propionic acid;mecoprop (ISO); 2-(4-chloro-o-tolyloxy)propionic acid; (RS)-2-(4-chloro-o-tolyloxy)propionic acid
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
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