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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
Brugia pahangi
-
-
P Parasites
bufa-4,20,22-trienolide, 6-(acetyloxy)-3-(β-D-glucopyranosyloxy)-8,14-dihydroxy-, (3β, 6β)-; red squill; scilliroside
208-077-4
507-60-8
Acute Tox. 2
bufencarb (ISO); reaction mass of 3-(1-methylbutyl)phenyl N-methylcarbamate and 3-(1-ethylpropyl)phenyl N-methylcarbamate
620-359-2
8065-36-9
Acute Tox. 3
Buffalopox virus
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
bunsenite
-
34492-97-2
Carc. 1A; STOT RE 1; Skin Sens. 1
Bunyamwera virus
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
bupirimate (ISO); 5-butyl-2-ethylamino-6-methylpyrimidin-4-yl dimethylsulphamate
255-391-2
41483-43-6
Carc. 2; Skin Sens. 1B
Burkholderia mallei
-
-
B Bacteria and similar species
Burkholderia pseudomallei
-
-
B Bacteria and similar species
but-1-ene
203-449-2
106-98-9
Flam. Gas 1; Press. Gas
but-2-yne-1,4-diol; 2-butyne-1,4-diol
203-788-6
110-65-6
Skin Corr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
butan-1-ol; n-butanol
200-751-6
71-36-3
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
butane;butane (containing ≥ 0,1 % butadiene (203-450-8))
203-448-7
106-97-8
Flam. Gas 1; Press. Gas
butane;butane (containing ≥ 0,1 % butadiene (203-450-8))
203-448-7
106-97-8
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime
202-496-6
96-29-7
Carc. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3; STOT SE 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
butanone; ethyl methyl ketone
201-159-0
78-93-3
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
butene, mixed-1-and-2-isomers
203-452-9
107-01-7
Flam. Gas 1; Press. Gas
butocarboxim (ISO); 3-(methylthio)-2-butanone O-[(methylamino)carbonyl]oxime
252-139-3
34681-10-2
Flam. Liq. 3; Acute Tox. 3; Eye Irrit. 2
butroxydim (ISO); 5-(3-butyryl-2,4,6-trimethylphenyl)-2-[1-(ethoxyimino)propyl]-3-hydroxycyclohex-2-en-1-one
BUTROXYDIM; ICIA0500
414-790-3
138164-12-2
Repr. 2; Acute Tox. 4; Skin Irrit. 2
butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium (trialkyloxy)titanium phosphate
TILCOM CA35; TILCOM IA10; TYTAN AP 100; TYTAN CA 100; TYTAN CX 35; TYZOR IAM
401-100-0
109037-78-7
Flam. Liq. 2; Eye Irrit. 2
Butyl 4-hydroxybenzoate
202-318-7
94-26-8
yes
butyl butyrate
203-656-8
109-21-7
Flam. Liq. 3
butyl chloroformate; chloroformic acid butyl ester
209-750-5
592-34-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
butyl formate
209-772-5
592-84-7
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
butyl glycidyl ether; butyl 2,3-epoxypropyl ether
219-376-4
2426-08-6
Flam. Liq. 3; Carc. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Sens. 1
butyl nitrite
208-862-1
544-16-1
Flam. Liq. 2; Acute Tox. 3
butylamine
203-699-2
109-73-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
butyltricyclohexylstannane
230-358-5
7067-44-9
Acute Tox. 4
butyraldehyde
204-646-6
123-72-8
Flam. Liq. 2
butyraldehyde oxime
203-792-8
110-69-0
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
butyric acid
203-532-3
107-92-6
Skin Corr. 1B
butyryl chloride
205-498-5
141-75-3
Flam. Liq. 2; Skin Corr. 1B
C,C'-azodi(formamide)
204-650-8
123-77-3
Resp. Sens. 1
yes
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
Carc. 2; Acute Tox. 4; Eye Dam. 1
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
yes
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
Carc. 1B; Acute Tox. 4; Eye Dam. 1
C.I. Disperse Yellow 3; N-[4-[(2-hydroxy-5-methylphenyl)azo]phenyl]acetamide
220-600-8
2832-40-8
Carc. 2; Skin Sens. 1
C.I. Solvent Yellow 14; 1-phenylazo-2-naphthol
212-668-2
842-07-9
Carc. 2; Muta. 2; Skin Sens. 1
C12-14-tert-alkyl ammonium 1-amino-9,10-dihydro-9,10-dioxo-4-(2,4,6-trimethylanilino)-anthracen-2-sulfonate
ORASOL BLAU 761B
414-110-5
1379678-96-2
Eye Dam. 1
C12-14-tert-alkylamine, methylphosphonic acid salt
CD 23-404
404-750-3
119415-07-5
Acute Tox. 4; Skin Corr. 1B
C8-10 alkyl dimethyl hydroxyethyl ammoniumchloride (chain < C8: <3 %, chain = C8: 15 %-70 %, chain = C10: 30 %- 85 %, chain > C10: <3 %)
417-360-3
1379678-84-8
Acute Tox. 4; Skin Irrit. 2
C8-18 alkylbis(2-hydroxyethyl)ammonium bis(2-ethylhexyl)phosphate
INTERSEPT
404-690-8
68132-19-4
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
cadmium carbonate
208-168-9
513-78-0
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
cadmium chloride
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cadmium chloride (CdCl2), hydrate (2:5) EC / List no: 640-998-0 | CAS no: 7790-78-5
233-296-7
10108-64-2
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
Cadmium chloride, hydrate (2:5)
640-998-0
7790-78-5
yes
cadmium compounds, with the exception of cadmium sulphoselenide (xCdS.yCdSe), reaction mass of cadmium sulphide with zinc sulphide (xCdS.yZnS), reaction mass of cadmium sulphide with mercury sulphide (xCdS.yHgS), and those specified elsewhere in this Annex
-
-
Acute Tox. 4
cadmium cyanide
208-829-1
542-83-6
Acute Tox. 2; Acute Tox. 1; Carc. 2; STOT RE 2
cadmium diformate; cadmiumformate
224-729-0
4464-23-7
Acute Tox. 3; Carc. 2; STOT RE 2
cadmium fluoride
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
cadmium hydroxide; cadmium dihydroxide
244-168-5
21041-95-2
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
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