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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
4-ethoxyaniline; p-phenetidine
205-855-5
156-43-4
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
4-ethyl-2-methyl-2-isopentyl-1,3-oxazolidine
ZOLDINE (R) MS-52
410-470-2
137796-06-6
Skin Corr. 1B; Skin Sens. 1
4-ethylamino-3-nitrobenzoic acid
RO 827
412-090-2
2788-74-1
Acute Tox. 4; Skin Sens. 1
4-fluoro-3-trifluoromethylphenol
432-560-0
61721-07-1
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
4-formylphenylboronic acid
438-670-5
87199-17-5
Skin Sens. 1
4-Heptylphenol
217-862-0
1987-50-4
yes
4-Heptylphenol, branched and linear
-
-
yes
4-hexadecyl-1-phenylpyrazolidin-3-one
430-840-7
202483-63-4
Skin Sens. 1
4-hydroxy-3-(3-(4'-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin; brodifacoum
259-980-5
56073-10-0
Repr. 1A; Acute Tox. 1; STOT RE 1
4-hydroxy-4-methylpentan-2-one; diacetone alcohol
204-626-7
123-42-2
Eye Irrit. 2
4-hydroxy-7-(2-aminoethyl)-1,3-benzothiazol-2(3H)-one hydrochloride
432-470-1
189012-93-9
Eye Dam. 1; Skin Sens. 1
4-isocyanatosulphonyltoluene; tosyl isocyanate
223-810-8
4083-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
4-mesyl-2-nitrotoluene
430-550-0
1671-49-4
Repr. 2; Acute Tox. 4; Skin Sens. 1
4-methoxy-4-methylpentan-2-one
203-512-4
107-70-0
Flam. Liq. 3; Acute Tox. 4
4-methoxy-N,6-dimethyl-1,3,5- triazin-2-ylamine
2-METHOXY-4-METHYL-6-METHYLAMINO-1,3,5-TRIAZIN; DPX-L5296; L5296
401-360-5
5248-39-5
Acute Tox. 4; STOT RE 2
4-methyl-3-oxo-N-phenyl-2-(phenylmethylene)pentanamide
425-860-8
125971-57-5
Skin Sens. 1
4-methyl-8-methylenetricyclo[3.3.1.1 3,7]decan-2-ol
PRISMANTOL
406-330-5
122760-84-3
Skin Irrit. 2; Skin Sens. 1
4-methyl-8-methylenetricyclo[3.3.1.13,7]dec-2-yl acetate
PRISMYLATE
406-560-6
122760-85-4
Skin Irrit. 2; Skin Sens. 1
4-methyl-m-phenylene diisocyanate; toluene-2,6-di-isocyanate
209-544-5
584-84-9
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
202-453-1
95-80-7
yes
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
4-methyl-N-(methylsulfonyl)benzenesulfonamide
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
4-methylheptane
209-650-1
589-53-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
4-methylpent-3-en-2-one; mesityl oxide
205-502-5
141-79-7
Flam. Liq. 3; Acute Tox. 4
4-methylpentan-2-ol; methyl isobutyl carbinol
203-551-7
108-11-2
Flam. Liq. 3; STOT SE 3
4-methylpentan-2-one; isobutyl methyl ketone
203-550-1
108-10-1
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
4-methylpyridine; 4-picoline
203-626-4
108-89-4
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
4-nitrobiphenyl
202-204-7
92-93-3
Carc. 1B
4-nitrophenol; p-nitrophenol
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
4-nitrosoaniline
211-535-6
659-49-4
Acute Tox. 4
4-nitrosophenol
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
4-nitrotoluene
202-808-0
99-99-0
Acute Tox. 3; STOT RE 2
4-nonylphenol, branched
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
4-Nonylphenol, branched and linear
-
-
yes
4-Nonylphenol, branched and linear, ethoxylated
-
-
yes
4-Nonylphenol, branched, ethoxylated (1 - 2.5 moles ethoxylated)
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
4-Nonylphenol, ethoxylated (1 - 2.5 moles ethoxylated)
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
4-nonylphenol, reaction products with formaldehyde and dodecane-1-thiol
POLYSTAY K; WINGSTAY K
404-160-6
164907-73-7
Skin Sens. 1
4-o-tolylazo-o-toluidine; 4-amino-2',3-dimethylazobenzene; fast garnet GBC base; AAT; o-aminoazotoluene
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
4-oxo-4-(p-tolyl)butyric acid adduct with 4-ethylmorpholine
419-240-6
171054-89-0
Eye Dam. 1
4-phenylbut-1-ene
4-PHENYL-1-BUTENE; SQ 31,175; SQ31175
405-980-7
768-56-9
Skin Irrit. 2
4-propylcyclohexanone
BICH-3 STUFE 3
406-810-4
40649-36-3
Skin Irrit. 2
4-tert-butylbenzoic acid
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
4-tert-butylphenol
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
4-tert-Octylphenol monoethoxylate
621-345-9
2315-67-5
yes
4-vinylcyclohexene
202-848-9
100-40-3
Carc. 2
4-{[(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amino}furan-2(5H)-one; flupyradifurone
804-373-8
951659-40-8
Acute Tox. 4; STOT RE 2
4H-3,1-benzoxazine-2,4(1H)-dione
204-255-0
118-48-9
Eye Irrit. 2; Skin Sens. 1
5(or 6)-tert-butyl-2'-chloro-6'-ethylamino-3',7'-dimethylspiro(isobenzofuran-1(1H),9'-xanthene)-3-one
R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
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