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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 25 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
Yersinia pseudotuberculosis
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B Bacteria and similar species
Yersinia spp.
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B Bacteria and similar species
zinc chromates including zinc potassium chromate
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Zinc dichromate EC / List no: 237-843-0 | CAS no: 14018-95-2
Potassium hydroxyoctaoxodizincatedichromate(1-) EC / List no: 234-329-8 | CAS no: 11103-86-9
C.I. Pigment Yellow 36 EC / List no: 609-398-6 | CAS no: 37300-23-5
Zinc chromate EC / List no: 236-878-9 | CAS no: 13530-65-9
Pentazinc chromate octahydroxide EC / List no: 256-418-0 | CAS no: 49663-84-5
Chromic acid, potassium zinc salt EC / List no: 255-252-6 | CAS no: 41189-36-0
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Carc. 1A; Acute Tox. 4; Skin Sens. 1
'amyl nitrite', mixed isomers
203-770-8
110-46-3
Flam. Liq. 2; Acute Tox. 4
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
214-619-0
1166-46-7
Carc. 2; Acute Tox. 4; STOT SE 2
(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate
256-032-2
42978-66-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
(1α,2α,3β,6β)-1,2,3,6-tetrahydro-3,6-methanophthalic anhydride
220-384-5
2746-19-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
(2-ethylhexanoato-O)(isodecanoato-O)nickel
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(2-ethylhexanoato-O)(isononanoato-O)nickel
287-470-2
85508-45-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(2R,6aS,12aS)-1,2,6,6a,12,12a-hexahydro-2-isopropenyl-8,9-dimethoxychromeno[3,4-b]furo[2,3-h]chromen-6-one, rotenone
201-501-9
83-79-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
(3-chloro-2-hydroxypropyl); trimethylammonium chloride ...%
222-048-3
3327-22-8
Carc. 2
(4-ammonio-m-tolyl)ethyl(2-hydroxyethyl)ammonium sulphate; 4-(N-ethyl-N-2-hydroxyethyl)-2-methylphenylenediamine sulphate
247-162-0
25646-77-9
Acute Tox. 3; STOT RE 2; Skin Sens. 1
(benzothiazol-2-ylthio)methyl thiocyanate; TCMTB
244-445-0
21564-17-0
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
(E)-2-butenal; (E)-crotonaldehyde
204-647-1
123-73-9
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
(E)-2-methoxy-4-(prop-1-enyl)phenol
227-678-2
5932-68-3
Skin Sens. 1A
(E)-but-2-ene
210-855-3
624-64-6
Flam. Gas 1; Press. Gas
(isodecanoato-O)(isononanoato-O)nickel
284-348-0
84852-36-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(isodecanoato-O)(isooctanoato-O)nickel
285-909-2
85166-19-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(isononanoato-O)(isooctanoato-O)nickel
287-471-8
85508-46-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(isononanoato-O)(neodecanoato-O)nickel
287-592-6
85551-28-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(isooctanoato-O)(neodecanoato-O)nickel
284-347-5
84852-35-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(R)-4-hydroxy-3-(3-oxo-1-phenylbutyl)-2-benzopyrone
226-908-9
5543-58-8
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
(R)-butan-2-ol
238-967-8
14898-79-4
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
(R)-p-mentha-1,8-diene; d-limonene
227-813-5
5989-27-5
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
(R)-sec-butylamine; (R)-2-aminobutane
236-232-6
13250-12-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
(S)-4-hydroxy-3-(3-oxo-1-phenylbutyl)-2-benzopyrone
226-907-3
5543-57-7
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
(S)-butan-2-ol
224-168-1
4221-99-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
(S)-p-mentha-1,8-diene; l-limonene
227-815-6
5989-54-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
(S)-sec-butylamine; (S)-2-aminobutane
208-164-7
513-49-5
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
(Z)-1,3-dichloropropene
233-195-8
10061-01-5
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
(Z)-2-methoxy-4-(prop-1-enyl)phenol
227-633-7
5912-86-7
Skin Sens. 1A
(Z)-but-2-ene
209-673-7
590-18-1
Flam. Gas 1; Press. Gas
(Z)-octadec-9-enylamine
204-015-5
112-90-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
(±)-1-[2-(allyloxy)ethyl-2-(2,4- dichlorophenyl)]-1H-imid azolium hydrogen sulphate
281-291-3
83918-57-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
(±)-1-[2-(allyloxy)ethyl-2-(2,4- dichlorophenyl)]-1H-imid azolium hydrogen sulphate
281-291-3
83918-57-4
Acute Tox. 4; Skin Sens. 1
(±)-1-methyl-4-(1-methylvinyl)cyclohexene;dipentene; limonene
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
(±)-1-methyl-4-(1-methylvinyl)cyclohexene;dipentene; limonene
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
(±)-butan-2-ol;butan-2-ol
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
(±)-butan-2-ol;butan-2-ol
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
1,1',1'-nitrilotripropan-2-ol; triisopropanolamine
204-528-4
122-20-3
Eye Irrit. 2
1,1'-dioxybiscyclohexan-1-ol [> 91 % solution];1,1'-dioxybiscyclohexan-1-ol [≤ 91 % solution]
219-306-2
2407-94-5
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
1,1'-dioxybiscyclohexan-1-ol [> 91 % solution];1,1'-dioxybiscyclohexan-1-ol [≤ 91 % solution]
219-306-2
2407-94-5
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
1,1'-iminodipropan-2-ol; di-isopropanolamine
203-820-9
110-97-4
Eye Irrit. 2
1,1,1-trichloroethane; methyl chloroform
200-756-3
71-55-6
Acute Tox. 4
1,1,2,2-tetrabromoethane
201-191-5
79-27-6
Acute Tox. 2; Eye Irrit. 2
1,1,2,2-tetrachloroethane
201-197-8
79-34-5
Acute Tox. 2; Acute Tox. 1
1,1,2-trichloroethane
201-166-9
79-00-5
Carc. 2; Acute Tox. 4
1,1-dichloro-1-nitroethane
209-854-0
594-72-9
Acute Tox. 3
1,1-dichloroethane
200-863-5
75-34-3
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
1,1-dichloroethylene; vinylidene chloride
200-864-0
75-35-4
Flam. Liq. 1; Carc. 2; Acute Tox. 4
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