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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 23 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
basic phenylmercury nitrate	620-403-0	8003-05-2	Acute Tox. 3; STOT RE 1; Skin Corr. 1B
BBP; benzyl butyl phthalate e	201-622-7	85-68-7	Repr. 1B		yes
Bebaru 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.
behenamidopropyl-dimethyl-(dihydroxypropyl) ammonium chloride LEXQUAT AMG-BEO (CONCENTRATE)	423-420-1	136920-10-0	Eye Dam. 1; Skin Sens. 1
Belgrade	-	-		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.
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
benfuracarb (ISO); ethyl N-[2,3-dihydro-2,2-dimethylbenzofuran-7-yloxycarbonyl(methyl)aminothio]-N-isopropyl-β-alaninate	617-356-3	82560-54-1	Repr. 2; Acute Tox. 3; Acute Tox. 4
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
bensultap (ISO); 1,3-bis(phenylsulfonylthio)-2-(N,N-dimethylamino)propane	605-769-1	17606-31-4	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
benzenesulfonic acid, 3,3'-(methylenebis((dihydroxyphenylene)azo)) bis-, potassium sodium salt; potassium sodium 3-[(E)-(6{3,4-dihydroxy-2-}(Z)-(3-sulfonatophenyl)diazenyl]benzyl}-2,3-dihydroxyphenyl)diazenyl]benzenesulfonate HWL-158	432-590-4	243869-48-9	Eye Irrit. 2
benzidine based azo dyes; 4,4'-diarylazobiphenyl dyes, with the exception of those specified elsewhere in this Annex	-	-	Carc. 1B
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
benzoic acid, N-tert-butyl-N'-(4-chlorobenzoyl)hydrazide	431-600-4	112226-61-6	Skin Sens. 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
benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide	691-719-4	1072957-71-1	Acute Tox. 3
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 2,4-dibromobutanoate B2,4DBB	420-710-8	23085-60-1	Repr. 2; Skin Irrit. 2; Skin Sens. 1
benzyl [hydroxy-(4-phenylbutyl)phosphinyl] acetate SQ 28,355; SQ 28355	416-050-5	87460-09-1	Eye Dam. 1
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
benzyl(S)-2-[(2'-cyanobiphenyl-4-ylmethyl)pentanoylamino]-3-methylbutyrate	427-470-3	137864-22-3	Acute Tox. 4; Skin Sens. 1
benzyl-2-hydroxydodecyldi; methylammonium benzoate B 2049	402-610-6	113694-52-3	Skin Corr. 1B; Acute Tox. 4
benzyl-N-(2-(2-methoxyphenoxy)ethyl)amine hydrochloride BM 96.0258.HCL	428-290-8	120606-08-8	Acute Tox. 4; Eye Dam. 1
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
benzyldimethyloctadecylammonium 3-nitrobenzenesulfonate CA10	405-330-2	124088-59-1	Skin Irrit. 2; Eye Dam. 1

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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 23 april 2024. Database contains 4753 unique substances/entries.

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