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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 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
carboxin (ISO); 2-methyl-N-phenyl-5,6-dihydro-1,4-oxathiine-3-carboxamide; 5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide	226-031-1	5234-68-4	STOT RE 2; Skin Sens. 1
Cardiobacterium hominis	-	-		B Bacteria and similar species
cartap hydrochloride	239-309-2	15263-52-2	Acute Tox. 4
carvone (ISO); 2-methyl-5-(prop-1-en-2-yl)cyclohex-2-en-1-one	202-759-5	99-49-0	Skin Sens. 1
cellobiohydrolase, exo-	253-465-9	37329-65-0	Resp. Sens. 1
cellulase	232-734-4	9012-54-8	Resp. Sens. 1
cellulases with the exception of those specified elsewhere in this Annex	-	-	Resp. Sens. 1
cellulose nitrate; nitrocellulose	618-392-2	9004-70-0	Expl. 1.1
Central European tick-borne encephalitis 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.
Chikungunya 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.
Chlamydia pneumoniae	-	-		B Bacteria and similar species
Chlamydia psittaci (avian strains)	-	-		B Bacteria and similar species
Chlamydia psittaci (other strains)	-	-		B Bacteria and similar species
Chlamydia trachomatis	-	-		B Bacteria and similar species
chloral hydrate; 2,2,2-trichloroethane-1,1-diol	206-117-5	302-17-0	Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
chloralose (INN); (R)-1,2-O-(2,2,2-trichloroethylidene)-α-D-glucofuranose; glucochloralose; anhydroglucochloral	240-016-7	15879-93-3	Acute Tox. 4; Acute Tox. 3; STOT SE 3
chlordane (ISO); 1,2,4,5,6,7,8,8-octachloro-3a,4,7,7a-tetrahydro-4,7-methanoindan	200-349-0	57-74-9	Carc. 2; Acute Tox. 4
chlordecone (ISO); perchloropentacyclo[5,3,0,02,6,03,9,0 4,8]decan-5-one; decachloropentacyclo[5,2,1,02,6,03,9,05,8]decan-4-one	205-601-3	143-50-0	Carc. 2; Acute Tox. 3
chlordimeform (ISO); N2-(4-chloro-o-tolyl)-N1,N1-dimethylformamidine	228-200-5	6164-98-3	Carc. 2; Acute Tox. 4
chlordimeform hydrochloride; N'-(4-chloro-o-tolyl)-N,N-dimethylformamidine monohydrochloride; N2-(4-chloro-o-tolyl)-N1,N1-dimethylformamidine hydorchloride	243-269-1	19750-95-9	Carc. 2; Acute Tox. 4
chlorfenac(ISO); 2,3,6-trichlorophenylacetic acid	201-599-3	85-34-7	Acute Tox. 4
chlorfenapyr (ISO); 4-bromo-2-(4-chlorophenyl)-1-ethoxymethyl-5-trifluoromethylpyrrole-3-carbonitrile	602-782-4	122453-73-0	Acute Tox. 3; Acute Tox. 4
chlorfenethol (ISO); 1,1-bis (4-chlorophenyl) ethanol	201-246-3	80-06-8	Acute Tox. 4
chlorfenprop-methyl; methyl 2-chloro-3-(4-chlorophenyl)propionate	238-413-5	14437-17-3	Acute Tox. 4
chlorfenson (ISO); 4-chlorophenyl 4-chlorobenzenesulfonate	201-270-4	80-33-1	Acute Tox. 4; Skin Irrit. 2
chlorfenvinphos (ISO); 2-chloro-1-(2,4 dichlorophenyl)vinyl diethyl phosphate	207-432-0	470-90-6	Acute Tox. 2; Acute Tox. 3
chloridazon (ISO); 5-amino-4-chloro-2-phenylpyridazine-3-(2H)-one; pyrazon	216-920-2	1698-60-8	Skin Sens. 1
chlorine	231-959-5	7782-50-5	Ox. Gas 1; Press. Gas; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
chlorine dioxide;chlorine dioxide ... %	233-162-8	10049-04-4	Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
chlorine dioxide;chlorine dioxide ... %	233-162-8	10049-04-4	Acute Tox. 3; Skin Corr. 1B
chlormephos (ISO); S-chloromethyl O,O-diethyl phosphorodithioate	246-538-1	24934-91-6	Acute Tox. 1; Acute Tox. 2
chlormequat chloride (ISO); 2-chloroethyltrimethylammonium chloride	213-666-4	999-81-5	Acute Tox. 4
chlormethyl methyl ether; chlorodimethyl ether	203-480-1	107-30-2	Flam. Liq. 2; Carc. 1A; Acute Tox. 4
chloro(3-(3-chloro-4-fluorophenyl)propyl)dimethylsilane SILAN MCS	410-270-5	770722-46-8	Skin Corr. 1A
chloro-1-ethylcyclohexyl carbonate	444-950-8	99464-83-2	Muta. 2; Skin Sens. 1
chloro-N, N-dimethylformiminium chloride SEL DE VILSMEIER-HAACK	425-970-6	3724-43-4	Repr. 1B; Acute Tox. 4; Skin Corr. 1A
chloroacetaldehyde	203-472-8	107-20-0	Carc. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
chloroacetic acid	201-178-4	79-11-8	Acute Tox. 3; Skin Corr. 1B
chloroacetonitrile	203-467-0	107-14-2	Acute Tox. 3
chloroacetyl chloride	201-171-6	79-04-9	Acute Tox. 3; STOT RE 1; Skin Corr. 1A
chloroanilines (with exception of those specified elsewhere in this Annex)	-	-	Acute Tox. 3; STOT RE 2
chlorobenzene	203-628-5	108-90-7	Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
chlorobenzilate (ISO); ethyl 2,2-di(4-chlorophenyl)-2-hydroxyacetate; ethyl 4,4'-dichlorobenzilate	208-110-2	510-15-6	Acute Tox. 4
chlorocresol; 4-chloro-m-cresol; 4-chloro-3-methylphenol	200-431-6	59-50-7	Acute Tox. 4; Skin Corr. 1C; Eye Dam. 1; STOT SE 3; Skin Sens. 1B
chlorodinitrobenzene	247-109-1	25567-67-3	Acute Tox. 3; STOT RE 2
chloroethane	200-830-5	75-00-3	Flam. Gas 1; Press. Gas; Carc. 2
chloroform; trichloromethane	200-663-8	67-66-3	Carc. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
chloromethane; methyl chloride	200-817-4	74-87-3	Flam. Gas 1; Press. Gas; Carc. 2; STOT RE 2
chloronitroanilines with the exception of those specified elsewhere in this Annex show/hide Benzenamine, 4-chloro-N-nitro- EC / List no: - \| CAS no: 69732-97-4 2-chloro-4-nitroaniline EC / List no: 204-502-2 \| CAS no: 121-87-9 Benzenamine, 3-chloro-5-nitro- EC / List no: - \| CAS no: 5344-44-5 4-chloro-2-nitroaniline EC / List no: 201-925-4 \| CAS no: 89-63-4 3-chloro-2-nitroaniline EC / List no: 261-782-9 \| CAS no: 59483-54-4 Benzenamine, 2-chloro-3-nitro- EC / List no: - \| CAS no: 3970-41-0 2-chloro-5-nitroaniline EC / List no: 228-498-7 \| CAS no: 6283-25-6 3-chloro-4-nitroaniline EC / List no: 642-644-0 \| CAS no: 825-41-2 4-chloro-3-nitroaniline EC / List no: 211-231-3 \| CAS no: 635-22-3 Benzenamine, chloronitro- EC / List no: - \| CAS no: 41587-36-4 5-chloro-2-nitroaniline EC / List no: 216-661-5 \| CAS no: 1635-61-6 N-chloro-2-nitroaniline EC / List no: - \| CAS no: 59483-60-2 2-chloro-6-nitroaniline EC / List no: 212-204-9 \| CAS no: 769-11-9	-	-	Acute Tox. 2; Acute Tox. 1; STOT RE 2
chlorophacinone (ISO); 2-(2-(4-chlorophenyl)phenylacetyl)indan-1,3-dione	223-003-0	3691-35-8	Repr. 1B; Acute Tox. 1; STOT RE 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 24 april 2024. Database contains 4753 unique substances/entries.

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