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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 16 May 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
cadmium nitrate; cadmium dinitrate	233-710-6	10325-94-7	Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
Cadmium nitrate	-	-			yes
cadmium iodide	232-223-6	7790-80-9	Acute Tox. 3; Carc. 2; STOT RE 2
cadmium hydroxide; cadmium dihydroxide	244-168-5	21041-95-2	Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1		yes
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 diformate; cadmiumformate	224-729-0	4464-23-7	Acute Tox. 3; Carc. 2; STOT RE 2
cadmium cyanide	208-829-1	542-83-6	Acute Tox. 2; Acute Tox. 1; Carc. 2; STOT RE 2
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 chloride, hydrate (2:5)	640-998-0	7790-78-5			yes
cadmium chloride show/hide 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 carbonate	208-168-9	513-78-0	Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1		yes
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
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
C12-14-tert-alkylamine, methylphosphonic acid salt CD 23-404	404-750-3	119415-07-5	Acute Tox. 4; Skin Corr. 1B
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
C.I. Solvent Yellow 14; 1-phenylazo-2-naphthol	212-668-2	842-07-9	Carc. 2; Muta. 2; Skin Sens. 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. 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,C'-azodi(formamide)	204-650-8	123-77-3	Resp. Sens. 1		yes
butyryl chloride	205-498-5	141-75-3	Flam. Liq. 2; Skin Corr. 1B
butyric acid	203-532-3	107-92-6	Skin Corr. 1B
butyraldehyde oxime	203-792-8	110-69-0	Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
butyraldehyde	204-646-6	123-72-8	Flam. Liq. 2
butyltricyclohexylstannane	230-358-5	7067-44-9	Acute Tox. 4
butylamine	203-699-2	109-73-9	Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
butyl nitrite	208-862-1	544-16-1	Flam. Liq. 2; Acute Tox. 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 formate	209-772-5	592-84-7	Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
butyl chloroformate; chloroformic acid butyl ester	209-750-5	592-34-7	Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
butyl butyrate	203-656-8	109-21-7	Flam. Liq. 3
Butyl 4-hydroxybenzoate	202-318-7	94-26-8			yes
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
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
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
butene, mixed-1-and-2-isomers	203-452-9	107-01-7	Flam. Gas 1; Press. Gas
butanone; ethyl methyl ketone	201-159-0	78-93-3	Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
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
butane;butane (containing ≥ 0,1 % butadiene (203-450-8))	203-448-7	106-97-8	Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
butane;butane (containing ≥ 0,1 % butadiene (203-450-8))	203-448-7	106-97-8	Flam. Gas 1; Press. Gas
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
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
but-1-ene	203-449-2	106-98-9	Flam. Gas 1; Press. Gas
Burkholderia pseudomallei	-	-		B Bacteria and similar species
Burkholderia mallei	-	-		B Bacteria and similar species
bupirimate (ISO); 5-butyl-2-ethylamino-6-methylpyrimidin-4-yl dimethylsulphamate	255-391-2	41483-43-6	Carc. 2; Skin Sens. 1B
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.
bunsenite	-	34492-97-2	Carc. 1A; STOT RE 1; Skin Sens. 1
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.

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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 16 May 2024. Database contains 4753 unique substances/entries.

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