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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
(2R,3R)-3-((R)-1-(tert-butyldimethylsiloxy)ethyl)-4-oxoazetidin-2-yl acetate
4-AA; AOSA; AZETIDONE-KANEKA; GR91990X
408-050-9
76855-69-1
Eye Irrit. 2; Skin Sens. 1
3-(2-(diaminomethyleneamino)thiazol-4-ylmethylthio)propionitrile
TPN
403-710-2
76823-93-3
Acute Tox. 4; Skin Sens. 1
sodium metabisulphite
231-673-0
7681-57-4
Acute Tox. 4; Eye Dam. 1
sodium hypochlorite, solution... % Cl active
231-668-3
7681-52-9
Skin Corr. 1B; Eye Dam. 1
sodium fluoride
231-667-8
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
sodium hydrogensulphate
231-665-7
7681-38-1
Eye Dam. 1
4-phenylbut-1-ene
4-PHENYL-1-BUTENE; SQ 31,175; SQ31175
405-980-7
768-56-9
Skin Irrit. 2
paclobutrazol (ISO); (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pentan-3-ol
616-379-6
76738-62-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
diniconazole (ISO);(E)-β-[(2,4-dichlorophenyl)methylene]-α-(1,1-dimethylethyl)-1H—1,2,4-triazol-1- ethanol;(E)-(RS)-1-(2,4-dichlorophenyl)-4,4-dimethyl-2-(1H—1,2,4- triazol-1-yl)pent-1-en-3-ol
617-485-5
76714-88-0
Acute Tox. 4
(2S, 5R)-6,6-dibromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide
427-200-4
76646-91-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
sulphuric acid ... %
231-639-5
7664-93-9
Skin Corr. 1A
ammonia, anhydrous
231-635-3
7664-41-7
Flam. Gas 2; Press. Gas; Acute Tox. 3; Skin Corr. 1B
hydrofluoric acid ... %;hydrogen fluoride
231-634-8
7664-39-3
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1A
hydrofluoric acid ... %;hydrogen fluoride
231-634-8
7664-39-3
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1A
phosphoric acid ... %, orthophosphoric acid ... %
231-633-2
7664-38-2
Skin Corr. 1B
hexasodium 2,2'-vinylenebis((3- sulfonato-4,1-pheny lene)imino(6-(N-cyanoethyl-N-(2-hydroxypropyl)amino)-1,3,5-triazine-4,2-diyl)imino)dibenzene-1,4-disulfonate
BRIGHTENER SM 1018 CONC.; LEUCOPHOR BCR
405-280-1
76508-02-6
Eye Irrit. 2
antimony pentachloride
231-601-8
7647-18-9
Skin Corr. 1B
hydrochloric acid ... %;hydrogen chloride
231-595-7
7647-01-0
Press. Gas; Acute Tox. 3; Skin Corr. 1A
hydrochloric acid ... %;hydrogen chloride
231-595-7
7647-01-0
Skin Corr. 1B; STOT SE 3
potassium hydrogensulphate
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
zinc chloride
231-592-0
7646-85-7
Acute Tox. 4; Skin Corr. 1B
cobalt dichloride
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
tin tetrachloride; stannic chloride
231-588-9
7646-78-8
Skin Corr. 1B
sodium hydride
231-587-3
7646-69-7
Water-react. 1
1,4-dichlorobut-2-ene
212-121-8
764-41-0
Carc. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
boron trifluoride
231-569-5
7637-07-2
Press. Gas; Acute Tox. 2; Skin Corr. 1A
Sodium peroxometaborate;sodium peroxometaborate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium peroxometaborate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Sodium peroxometaborate;sodium peroxometaborate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium peroxometaborate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
231-556-4
7632-04-4
yes
Sodium peroxometaborate;sodium peroxometaborate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium peroxometaborate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
sodium nitrite
231-555-9
7632-00-0
Ox. Sol. 3; Acute Tox. 3
sodium hydrogensulphite ... %; sodium bisulphite . . . %
231-548-0
7631-90-5
Acute Tox. 4
tert-butyl formate
212-105-0
762-75-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
(2,4-diaminopteridin-6-yl)methanol hydrobromide
430-620-0
76145-91-0
STOT RE 2; Skin Sens. 1
(1S,4R,6R,7R)-(4-nitrophenylmethyl)3-methylene-1-oxo-7-phenylacetamido-cepham-4-carboxylateido-penam-3-carboxylate
G-EXOMETHYLENE SULFOXIDE ESTER
412-800-0
76109-32-5
Resp. Sens. 1
perchloric acid ... %
231-512-4
7601-90-3
Ox. Liq. 1; Skin Corr. 1A
sodium perchlorate
231-511-9
7601-89-0
Ox. Sol. 1; Acute Tox. 4
fentin hydroxide (ISO); triphenyltin hydroxide
200-990-6
76-87-9
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
heptachlor (ISO); 1,4,5,6,7,8,8-heptachloro-3a,4,7,7a-tetrahydro-4,7-methanoindene
200-962-3
76-44-8
Carc. 2; Acute Tox. 3; STOT RE 2
trichloronitromethane; chloropicrin
200-930-9
76-06-2
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
trifluoroacetic acid . . . %
200-929-3
76-05-1
Acute Tox. 4; Skin Corr. 1A
TCA (ISO); trichloroacetic acid
200-927-2
76-03-9
Skin Corr. 1A
pentachloroethane
200-925-1
76-01-7
Carc. 2; STOT RE 1
diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
278-355-8
75980-60-8
Repr. 2
EPTC (ISO); S-ethyl dipropylthiocarbamate
212-073-8
759-94-4
Acute Tox. 4
di-n-octylaluminium iodide
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
2-ethylhexanoic acid, nickel salt
231-480-1
7580-31-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
diclobutrazole (ISO);(R*, R*)-(±)-β-[(2,4-dichlorop henyl)methyl]-α-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol; (2RS, 3RS)-1-(2,4-dichlorophenyl)-4,4-dimethyl-2- (1H—1,2,4-triazol-1yl)pentan-3-ol
620-436-0
75736-33-3
Eye Irrit. 2
dichloroacetylene
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
chrysoidine monoacetate; 4-(phenylazo)benzene-1,3-diamine monoacetate
278-290-5
75660-25-2
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
iodine
231-442-4
7553-56-2
Acute Tox. 4
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