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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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.

Last updated 27 December 2024. Database contains 4753 unique substances/entries.

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Showing 1 - 50 of 4,753 results.

Substance Name	EC No.	CAS No.	EU CLP (1272/2008)	EU REACH: List of SVHC
'amyl nitrite', mixed isomers	203-770-8	110-46-3	Flam. Liq. 2; Acute Tox. 4
((4-phenylbutyl)hydroxyphosphoryl)acetic acid SQ 26999	412-170-7	83623-61-4	STOT RE 2; Eye Dam. 1; Skin Sens. 1
(+)-(1S, 2S, 3S, 5R)-2,6,6-trimethylbicyclo[3.1.1]heptane-3-spiro-1'-(cyclohex-2'-en-4'-one)	430-460-1	133636-82-5	Skin Corr. 1B; Skin Sens. 1
(+/–)-(R,R)-6-fluoro-3,4-dihydro-2-oxiranyl-2H-1-benzopyran; 6-fluoro-2-(2-oxiranyl)chromane	419-620-1	-	Skin Sens. 1
(-)(3S, 4R)-4-(4-fluorophenyl)-3-(3,4-methylenedioxy-phenoxymethyl)-N-benzylpiperidine hydrochloride	432-360-3	105813-13-6	Acute Tox. 4; Skin Sens. 1
(-)-trans-4-(4'-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine BRL 29226	406-030-4	105812-81-5	Acute Tox. 4; Eye Dam. 1
(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-hydroxydodecylidene)diphosphonic acid KELCOR; LIPOKEL; SEQUOL	425-230-2	16610-63-2	Skin Corr. 1B
(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
(1R, 4R)-4-methoxy-2,2,7,7-tetramethyltricyclo(6.2.1.0(1,6))undec-5-ene	444-480-3	393517-29-8	Skin Irrit. 2
(1R,3S,7R,8R,10R,13R)-5,5,7,9,9,13-hexamethyl-4,6-dioxatetracyclo[6.5.1.01,10.03,7]tetradecane	427-580-1	211299-54-6	Skin Irrit. 2
(1R,4S)-2-azabicyclo[2.2.1]hept-5-en-3-one 1418U90	418-530-1	79200-56-9	Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(1S)-2-methyl-2,5-diazobicyclo[2.2.1]heptanes dihydrobromide CP-84,203-4; DFX-5S	411-000-9	125224-62-6	Skin Sens. 1
(1S,2S,5R,6R,9S,10S,13R,14R)-1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.1⁶,⁹.0²,¹³.0⁵,¹⁰]octadeca-7,15-diene	-	135821-03-3		yes
(1S,2S,5S,6S,9R,10R,13R,14R)-1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.1⁶,⁹.0²,¹³.0⁵,¹⁰]octadeca-7,15-diene	-	135821-74-8		yes
(1S,3S,5R,6R)-(4-nitrophenylmethyl)-1-dioxo-6-phenylacetamido-penam-3-carboxylate P-NITROBENZYLESTER PGSO	412-670-5	54275-93-3	Resp. 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
(1S-cis)-4-(2-amino-6-chloro-9H-purin-9-yl)-2-cyclopentene-1-methanol hydrochloride	426-200-1	172015-79-1	STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine 2-hydroxy-2-phenylacetate SERTRALINE STEP 2	420-560-3	79617-97-3	Eye Dam. 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
(1α5α6α)-6-nitro-3-benzyl-3-azabicyclo[3.1.0]hexane methanesulfonate salt CP-141,845-27	426-740-8	256369-40-1	Acute Tox. 4; Eye Dam. 1
(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(-3-(diethylammonio)propylamino)1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate BLUE 10 25 964	407-240-9	159604-94-1	Skin Sens. 1
(2,3,5,6-tetrafluorophenyl)methanol	443-840-7	4084-38-2	Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
(2,3-dimethylbut-2-yl)-trimethoxysilane	439-360-2	142877-45-0	Skin Irrit. 2; Eye Dam. 1
(2,4-diaminopteridin-6-yl)methanol hydrobromide	430-620-0	76145-91-0	STOT RE 2; Skin Sens. 1
(2,5-dioxopyrrolidin-1-yl)-9H-fluoren-9-ylmethyl carbonate	433-520-5	82911-69-1	Acute Tox. 4; Skin Sens. 1
(2,6-xylyloxy) acetic acid	430-910-7	13335-71-2	Acute Tox. 4; Eye Dam. 1
(2-(1,3-dioxolan-2-yl)ethyl)triphenylphosphonium bromide DWS	404-940-6	86608-70-0	Acute Tox. 4; Eye Dam. 1; STOT RE 2
(2-(aminomethyl)phenyl)acetylchloride hydrochloride X-17-17	417-410-4	61807-67-8	Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
(2-butyl-5-nitrobenzofuran-3-yl)[4-(3-dibutylaminopropoxy)phenyl]methanone BUTAMINONITRODARONE; SR33581	444-800-1	141645-23-0	Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
(2-chloroethyl)(3-hydroxypropyl)ammonium chloride CLETOPROPAMINHYDROCHLORID	429-740-6	40722-80-3	Carc. 1B; Muta. 1B; STOT RE 2; 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
(2-methylpropyl)lithium; isobutyllithium	440-620-2	920-36-5	Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A; STOT SE 3
(2R)-2-amino-2-phenylacetamide	420-370-0	6485-67-2	Eye Irrit. 2; Skin Sens. 1
(2R, 3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (1R)-10-camphorsulfonate UK-103,449-BV	427-100-0	-	Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(2R, 3S, 4R, 5R, 7R, 9R, 10R,11S, 12S, 13R)-10-[(4-dimethylamino-3-hydroxy-6-methyltetrahydropyran-2-yl)oxy]-2-ethyl-3,4,12-trihydroxy-9-methoxy-3,5,7,9,11,13-hexamethyl-6,14-dioxo-1-oxacyclotetradecane	433-820-6	118058-74-5	Eye Irrit. 2
(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
(2R,3S)-N-(3-amino-2-hydroxy-4-phenylbutyl)-N-isobutyl-4-nitrobenzenesulfonamide hydrochloride	425-260-6	244634-31-9	STOT RE 2; Eye Dam. 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
(2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol; mefentrifluconazole	822-682-6	1417782-03-6	Skin Sens. 1
(2S)-5-(benzyloxy)-2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)-5-oxopentanoic acid	443-560-5	88784-33-2	Eye Irrit. 2
(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
(3'-carboxymethyl-5-(2-(3-ethyl-3H-benzothiazol-2-ylidene)-1-methyl-ethylidene)-4,4'-dioxo-2'-thioxo-(2,5')bithiazolidinyliden-3-yl)-acetic acid CIN 10094329; SENSIBILISATOR KF 693 PINA; SENSITIZER KF 693 PINA	422-240-9	166596-68-5	Eye Dam. 1; Skin Sens. 1
(3-aminophenyl)pyridin-3-ylmethanone	428-230-0	79568-06-2	STOT RE 2
(3-chloro-2-hydroxypropyl); trimethylammonium chloride ...%	222-048-3	3327-22-8	Carc. 2
(3-chlorophenyl)-(4-methoxy-3-nitrophenyl)methanone T 1569; T001569	423-290-4	66938-41-8	Muta. 2
(3S, 4aS, 8aS)-N-tert-butyldecahydro-3-isoquinolinecarboxamide	420-380-5	136465-81-1	Acute Tox. 4; Eye Dam. 1
(3S, 6R, 9S, 12R, 15S, 18R, 21S,24R)-6,18-dibenzyl-3,9,15,21-tetraisobutyl-4,10,12,16,22,24-hexamethyl-1,7,13,19-tetraoxa-4,10,16,22-tetraazacyclo-tetracosane-2,5,8,11,14,17,20,23-octaone	444-350-6	133413-70-4	Eye Irrit. 2
(3S,4aS,8aS)-2-[(2R,3S)-3-amino-2-hydroxy-4-phenylbutyl]-N-tert-butyldecahydroisoquinoline-3-carboxamide PTH-AA	430-230-0	136522-17-3	Acute Tox. 4

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EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1

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

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Last updated 27 December 2024. Database contains 4753 unique substances/entries.

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