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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 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
(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
(R)-2-chloro-N-(2-ethyl-6-methyl-phenyl)-N-(2-methoxy-1-methyl-ethyl)-acetamide (0-20 %)	-	178961-20-1	Skin Sens. 1
1,1-dimethyl-3-phenyluronium trichloroacetate; fenuron-TCA	-	4482-55-7	Skin Irrit. 2
1,2,3,4-tetranitrocarbazole	-	6202-15-9	Expl. 1.1; Acute Tox. 4
1,2-dimethylhydrazine	-	540-73-8	Carc. 1B; Acute Tox. 3
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 (''Dechlorane Plus''™) including any of its individual anti- and syn-isomers or any combination thereof	-	-			yes
1-(3,4-dichlorophenylimino); thiosemicarbazide	-	5836-73-7	Acute Tox. 2
2,2-dichlorovinyl 2-ethylsulphinylethyl methyl phosphate	-	7076-53-1	Acute Tox. 3
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (1R,3R)-2,2-dimethyl-3-[(1Z)-prop-1-en-1-yl]cyclopropanecarboxylate; epsilon-metofluthrin	-	240494-71-7	Acute Tox. 4; Acute Tox. 3; STOT SE 1; STOT RE 2
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (Z)-(1R,3R)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate; epsilon-momfluorothrin	-	1065124-65-3	Acute Tox. 4; STOT SE 2
2,3-epoxypropyl-2-ethylcyclohexyl ether; ethylcyclohexylglycidyl ether	-	130014-35-6	Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,4,5-trimethylaniline hydrochloride	-	21436-97-5	Carc. 1B; Acute Tox. 3
2,7-naphthalenedisulfonic acid, nickel(II) salt	-	72319-19-8	Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
3-chloro-6-cyano-bicyclo(2,2,1)heptan-2-one-O-(N-methylcarbamoyl)oxime; triamid	-	15271-41-7	Acute Tox. 2; Acute Tox. 3
3-methylpyrazol-5-yl-dimethylcarbamate; monometilan	-	2532-43-6	Acute Tox. 3
4,4'-oxydianiline and its salts; p-aminophenyl ether	-	-	Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3		yes
4,4'-thiodianiline and its salts	-	-	Carc. 1B; Acute Tox. 4
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated	-	-			yes
4-Heptylphenol, branched and linear	-	-			yes
4-Nonylphenol, branched and linear	-	-			yes
4-Nonylphenol, branched and linear, ethoxylated	-	-			yes
5-(3,6,9-trioxa-2-undecy loxy)benzo(d)-1,3-dioxolane; sesamex	-	51-14-9	Acute Tox. 4
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane	-	-			yes
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]	-	-			yes
5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane	-	-			yes
8,9,10-trinorborn-2-yl acrylate	-	10027-06-2	Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
Absettarov	-	-		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.
Acanthamoeba castellani	-	-		P Parasites
Actinomadura madurae	-	-		B Bacteria and similar species
Actinomadura pelletieri	-	-		B Bacteria and similar species
Actinomyces gerencseriae	-	-		B Bacteria and similar species
Actinomyces israelii	-	-		B Bacteria and similar species
Actinomyces pyogenes	-	-		B Bacteria and similar species
Actinomyces spp.	-	-		B Bacteria and similar species
Acute haemorrhagic conjunctivitis 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.
Acyl Halides of 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid	-	-			yes
Adenoviridae	-	-		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.
Adinobacillus actinomycetemcomitans	-	-		B Bacteria and similar species
alkali salts and alkali earth salts of thiocyanic acid, with the exception of those specified elsewhere in this Annex	-	-	Acute Tox. 4
aluminium alkyls	-	-	Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
amidithion (ISO); 2-methoxyethylcarbamoylmethyl O,O-dimethyl phosphorodithioate	-	919-76-6	Acute Tox. 4
Ammonium salts of perfluorononan-1-oic-acid	-	4149-60-4	Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1		yes
amylases with the exception of those specified elsewhere in this Annex show/hide Amylase, β- EC / List no: 232-566-1 \| CAS no: 9000-91-3 Amylase, α- EC / List no: 232-565-6 \| CAS no: 9000-90-2 Amylase, α-, Aspergillus oryzae EC / List no: 232-588-1 \| CAS no: 9001-19-8 Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - \| CAS no: 68909-35-3 Amylase, fungal EC / List no: 232-742-8 \| CAS no: 9013-01-8 Amylase, gluco-, Rhizopus oryzae EC / List no: - \| CAS no: 152923-55-2 Amylase EC / List no: 232-567-7 \| CAS no: 9000-92-4 Amylase, iso- EC / List no: 232-956-1 \| CAS no: 9067-73-6 Amylase, alpha-, Bacillus amyloliquefaciens EC / List no: - \| CAS no: 152923-48-3 Amylase, bacterial EC / List no: 232-560-9 \| CAS no: 9000-85-5 Bacteria, complex with amylase and proteinase EC / List no: - \| CAS no: 68920-42-3 Amylase, mixed with proteinase, Bacillus thuringiensis-fermented EC / List no: - \| CAS no: 68909-36-4 Amylase, mixture with proteinase EC / List no: 685-079-5 \| CAS no: 9001-11-0 Amylase, gluco- EC / List no: 232-877-2 \| CAS no: 9032-08-0	-	-	Resp. Sens. 1
Ancylostoma duodenale	-	-		P Parasites
Angiostrongylus cantonensis	-	-		P Parasites
Angiostrongylus costaricensis	-	-		P Parasites
antimony compounds, with the exception of the tetroxide (Sb2O4), pentoxide (Sb2O5), trisulphide (Sb2S3), pentasulphide (Sb2S5) and those specified elsewhere in this Annex	-	-	Acute Tox. 4
Arcanobacterium haemolyticum	-	-		B Bacteria and similar species
arsenic acid and it salts with the exception of those specified elsewhere in this Annex	-	-	Carc. 1A; Acute Tox. 3

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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 19 April 2024. Database contains 4753 unique substances/entries.

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