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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 24 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
bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP
204-211-0
117-81-7
Repr. 1B
yes
bis(2-methoxyethyl) ether
203-924-4
111-96-6
Flam. Liq. 3; Repr. 1B
yes
bis(2-methoxyethyl) phthalate
204-212-6
117-82-8
Repr. 1B
yes
bis(3-(trimethoxysilyl)propyl)amine
280-084-5
82985-35-1
Eye Dam. 1
bis(4-hydroxy-N-methylanilinium) sulphate
200-237-1
55-55-0
Acute Tox. 4; STOT RE 2; Skin Sens. 1
bis(8-hydroxyquinolinium) sulphate
205-137-1
134-31-6
Acute Tox. 4
bis(chloromethyl) ether; oxybis(chloromethane)
208-832-8
542-88-1
Flam. Liq. 2; Carc. 1A; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
bis(d-gluconato-O1,O2)nickel
276-205-6
71957-07-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
bis(hydroxylammonium) sulfate; hydroxylamine sulfate (2:1)
233-118-8
10039-54-0
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
bis(N-hydroxy-N-nitrosocyclohexylaminato-O,O')copper; bis(N-cyclohexyl-diazenium-dioxy)-copper; [Cu-HDO]
239-703-4
15627-09-5
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
Bis(pentabromophenyl) ether; decabromodiphenyl ether; DecaBDE
214-604-9
1163-19-5
yes
bis(piperidinothiocarbonyl) disulphide
202-328-1
94-37-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Bis(tributyltin)oxide; TBTO
200-268-0
56-35-9
yes
bis(α,α-dimethylbenzyl) peroxide
201-279-3
80-43-3
Org. Perox. F; Repr. 1B; Skin Irrit. 2; Eye Irrit. 2
bis-[4-(2,3-epoxipropoxi)phenyl]propane
216-823-5
1675-54-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
bisphenol A; 4,4'-isopropylidenediphenol
201-245-8
80-05-7
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
yes
boric acid
234-343-4
11113-50-1
Repr. 1B
yes
boric acid
233-139-2
10043-35-3
Repr. 1B
yes
boron tribromide
233-657-9
10294-33-4
Acute Tox. 2; Skin Corr. 1A
boron trichloride
233-658-4
10294-34-5
Press. Gas; Acute Tox. 2; Skin Corr. 1B
boron trifluoride
231-569-5
7637-07-2
Press. Gas; Acute Tox. 2; Skin Corr. 1A
bromadiolone (ISO); 3-[3-(4'-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H-chromen-2-one
249-205-9
28772-56-7
Repr. 1B; Acute Tox. 1; STOT RE 1
bromelain, juice
232-572-4
9001-00-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
bromine
231-778-1
7726-95-6
Acute Tox. 2; Skin Corr. 1A
bromoacetic acid
201-175-8
79-08-3
Acute Tox. 3; Skin Corr. 1A; Skin Sens. 1
bromobenzene
203-623-8
108-86-1
Flam. Liq. 3; Skin Irrit. 2
bromoethane; ethyl bromide
200-825-8
74-96-4
Flam. Liq. 2; Carc. 2; Acute Tox. 4
bromoethylene
209-800-6
593-60-2
Press. Gas; Flam. Gas 1; Carc. 1B
bromofenoxim (ISO); 3,5-dibromo-4-hydroxybenzaldehyde-O-(2,4-dinitrophenyl)-oxime
236-129-6
13181-17-4
Acute Tox. 4
bromoform; tribromomethane
200-854-6
75-25-2
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
bromomethane; methylbromide
200-813-2
74-83-9
Press. Gas; Muta. 2; Acute Tox. 3; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
bromophos (ISO); O-4-bromo-2,5-dichlorophenyl O,O-dimethyl phosphorothioate
218-277-3
2104-96-3
Acute Tox. 4
bromophos-ethyl (ISO); O-4-bromo-2,5-dichlorophenyl; O,O-diethyl phosphorothioate
225-399-0
4824-78-6
Acute Tox. 3; Acute Tox. 4
bromoxynil (ISO) 3,5-dibromo-4-hydroxybenzonitrile; bromoxynil phenol
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2,6-dibromo-4-cyanophenyl octanoate EC / List no: 216-885-3 | CAS no: 1689-99-2
2,6-dibromo-4-cyanophenyl butyrate EC / List no: 223-374-9 | CAS no: 3861-41-4
2,6-dibromo-4-cyanophenyl heptanoate EC / List no: 260-300-4 | CAS no: 56634-95-8
3,5-dibromo-4-hydroxybenzonitrile EC / List no: 216-882-7 | CAS no: 1689-84-5
216-882-7
1689-84-5
Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
bromoxynil heptanoate (ISO); 2,6-dibromo-4-cyanophenyl heptanoate
260-300-4
56634-95-8
Repr. 2; Acute Tox. 4; Skin Sens. 1
bromoxynil octanoate (ISO); 2,6-dibromo-4-cyanophenyl octanoate
216-885-3
1689-99-2
Repr. 2; Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
bronopol (INN); 2-bromo-2-nitropropane-1,3-diol
200-143-0
52-51-7
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
brucine nitrate
227-317-9
5786-97-0
Acute Tox. 2
brucine sulphate
225-432-9
4845-99-2
Acute Tox. 2
brucine; 2,3-dimethoxystrychnine
206-614-7
357-57-3
Acute Tox. 2
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
bupirimate (ISO); 5-butyl-2-ethylamino-6-methylpyrimidin-4-yl dimethylsulphamate
255-391-2
41483-43-6
Carc. 2; Skin Sens. 1B
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
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