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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 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
barium perchlorate
236-710-4
13465-95-7
Ox. Sol. 1; Acute Tox. 4
barium peroxide
215-128-4
1304-29-6
Ox. Sol. 2; Acute Tox. 4
barium polysulphides
256-814-3
50864-67-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
barium sulphide
244-214-4
21109-95-5
Acute Tox. 4
BBP; benzyl butyl phthalate e
201-622-7
85-68-7
Repr. 1B
yes
benazolin (ISO); 4-chloro-2,3-dihydro-2-oxo-1,3-benzothiazol-3-ylacetic acid
223-297-0
3813-05-6
Eye Irrit. 2; Skin Irrit. 2
bendiocarb (ISO); 2,2-dimethyl-1,3-benzodioxol-4-yl N-methylcarbamate
245-216-8
22781-23-3
Acute Tox. 3; Acute Tox. 2
benomyl (ISO);methyl 1-(butylcarbamoyl)benzimidazol-2-ylcarbamate
241-775-7
17804-35-2
Muta. 1B; Repr. 1B; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
benquinox (ISO); p-benzoquinone 1-benzoylhydrazone 4-oxime
207-807-9
495-73-8
Acute Tox. 3; Acute Tox. 4
bensulide (ISO); O, O-diisopropyl 2-phenylsulphonylaminoethyl phosphorodithioate
212-010-4
741-58-2
Acute Tox. 4
bentazone (ISO);3-isopropyl-2,1,3-benzothiadiazine-4-one-2,2-dioxide
246-585-8
25057-89-0
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
benz[a]anthracene
200-280-6
56-55-3
Carc. 1B
yes
benz[e]acephenanthrylene
205-911-9
205-99-2
Carc. 1B
benzaldehyde
202-860-4
100-52-7
Acute Tox. 4
benzene
200-753-7
71-43-2
Flam. Liq. 2; Carc. 1A; Muta. 1B; STOT RE 1; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2
benzene-1,2,4-tricarboxylic acid 1,2-anhydride; trimellitic anhydride
209-008-0
552-30-7
STOT SE 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
benzene-1,2:4,5-tetracarboxylic dianhydride; benzene-1,2:4,5-tetracarboxylic dianhydride; pyromellitic dianhydride
201-898-9
89-32-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
benzene-1,4-diamine dihydrochloride; p-phenylenediamine dihydrochloride
210-834-9
624-18-0
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
benzidine; 1,1'-biphenyl-4,4'-diamine; 4,4'-diaminobiphenyl; biphenyl-4,4'-ylenediamine
202-199-1
92-87-5
Carc. 1A; Acute Tox. 4
benzo[a]pyrene; benzo[def]chrysene
200-028-5
50-32-8
Carc. 1B; Muta. 1B; Repr. 1B; Skin Sens. 1
yes
benzo[e]pyrene
205-892-7
192-97-2
Carc. 1B
Benzo[ghi]perylene
205-883-8
191-24-2
yes
benzo[j]fluoranthene
205-910-3
205-82-3
Carc. 1B
benzo[k]fluoranthene
205-916-6
207-08-9
Carc. 1B
yes
benzo[rst]pentaphene
205-877-5
189-55-9
Carc. 1B; Muta. 2
benzoic acid
200-618-2
65-85-0
STOT RE 1; Skin Irrit. 2; Eye Dam. 1
Benzol forerunnings (coal); Light Oil Redistillate, low boiling [The distillate from coke oven light oil having an approximate distillation range below 100 o C (212 °F). Composed primarily of C4 to C6 aliphatic hydrocarbons.]
The distillate from coke oven light oil having an approximate distillation range below 100°C (212°F). Composed primarily of C4 to C6 aliphatic hydrocarbons.
266-023-5
65996-88-5
Carc. 1B; Muta. 1B
benzonitrile
202-855-7
100-47-0
Acute Tox. 4
benzophenone-3,3',4,4'-tetracarboxylic dianhydride; 4,4'-carbonyldi(phthalic anhydride)
219-348-1
2421-28-5
Eye Irrit. 2; STOT SE 3
benzothiazole-2-thiol
205-736-8
149-30-4
Skin Sens. 1
benzoyl chloride
202-710-8
98-88-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
benzthiazuron (ISO); 1-benzothiazol-2-yl-3-methylurea
217-685-9
1929-88-0
Acute Tox. 4
benzyl alcohol
202-859-9
100-51-6
Acute Tox. 4
benzyl benzoate
204-402-9
120-51-4
Acute Tox. 4
benzyl chloroformate
207-925-0
501-53-1
Skin Corr. 1B
benzyl violet 4B; α-[4-(4-dimethylamino-α-{4-[ethyl(3-sodiosulphonato benzyl)amino] phenyl}benzylidene)cyclohexa-2,5-dienylidene(ethyl)ammonio]toluene-3-sulphonate
216-901-9
1694-09-3
Carc. 2
benzylamine
202-854-1
100-46-9
Acute Tox. 4; Skin Corr. 1B
benzyldimethylamine
203-149-1
103-83-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
beryllium
231-150-7
7440-41-7
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
beryllium oxide
215-133-1
1304-56-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
binapacryl (ISO); 2-sec-butyl-4,6-dinitrophenyl-3-methylcrotonate
207-612-9
485-31-4
Repr. 1B; Acute Tox. 4
biphenyl-2-ylamine
201-990-9
90-41-5
Carc. 2; Acute Tox. 4
biphenyl-3,3', 4,4'-tetrayltetraamine; diaminobenzidine
202-110-6
91-95-2
Carc. 1B; Muta. 2
biphenyl-4-ylamine; xenylamine; 4-aminobiphenyl
202-177-1
92-67-1
Carc. 1A; Acute Tox. 4
yes
biphenyl; diphenyl
202-163-5
92-52-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
bis(1,2,3-trithiacyclohexyldimethylammonium) oxalate; thiocyclam-oxalate
250-859-2
31895-22-4
Acute Tox. 4
bis(2,4,6-trinitrophenyl)amine; hexyl
205-037-8
131-73-7
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme
205-594-7
143-24-8
Repr. 1B
yes
bis(2-chloroethyl) ether
203-870-1
111-44-4
Carc. 2; Acute Tox. 2; Acute Tox. 1
bis(2-dimethylaminoethyl)(methyl)amine
221-201-1
3030-47-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
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