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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
salts of nicotine	-	-	Acute Tox. 2; Acute Tox. 1
salts of mecoprop	-	-	Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
salts of ioxynil with the exception of those specified elsewhere in this Annex show/hide 3,5-Diiodo-4-hydroxybenzonitrile, lithium salt EC / List no: - \| CAS no: 2961-61-7 Sodium 4-hydroxy-3,5-diiodophenylcyanide EC / List no: 220-995-7 \| CAS no: 2961-62-8	-	-	Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
salts of hyoscyamine	-	-	Acute Tox. 2
salts of hyoscine	-	-	Acute Tox. 2; Acute Tox. 1
salts of hydrogen cyanide with the exception of complex cyanides such as ferrocyanides, ferricyanides and mercuric oxycyanide and those specified elsewhere in this Annex	-	-	Acute Tox. 2; Acute Tox. 1
salts of hydrazine show/hide Hydrazine, dinitrate EC / List no: - \| CAS no: 13464-98-7 Hydrazine dihydrobromide EC / List no: 245-543-6 \| CAS no: 23268-00-0 Dithiocarbazic acid, compound with hydrazine (1:1) EC / List no: 243-844-7 \| CAS no: 20469-71-0 Hydrazinium chloride EC / List no: 220-154-4 \| CAS no: 2644-70-4 Hydrazine difluoride EC / List no: - \| CAS no: 13537-45-6 Hydrazine, sulfate EC / List no: - \| CAS no: 1184-66-3 Hydrazine tartrate EC / List no: 211-211-4 \| CAS no: 634-62-8 Hydrazinium dihydrogen phosphate EC / List no: 239-919-9 \| CAS no: 15823-35-5 Hydrazinium sulphamate EC / List no: 254-708-1 \| CAS no: 39935-03-0 Hydrazinium nitrate EC / List no: 236-690-7 \| CAS no: 13464-97-6 Hydrazine, sulfate (2:1), monohydrate EC / List no: - \| CAS no: 66375-32-4 Hydrazine, nitrate EC / List no: - \| CAS no: 37836-27-4 Hydrazine, dihydrobromide, dihydrate EC / List no: - \| CAS no: 40849-90-9 Hydrazine Acetate EC / List no: 629-465-3 \| CAS no: 13255-48-6 Hydrazine perchlorate EC / List no: - \| CAS no: 27978-54-7 Hydrazine dihydrochloride EC / List no: 226-283-2 \| CAS no: 5341-61-7 Hydrazinium acetate EC / List no: 230-845-2 \| CAS no: 7335-65-1 Hydrazine, diperchlorate, dihydrate EC / List no: - \| CAS no: 73497-82-2 Hydrazine, diperchlorate EC / List no: - \| CAS no: 13812-39-0 Hydrazine, monohydriodide EC / List no: - \| CAS no: 10039-55-1 Compound of carbonic acid with hydrazine(1:2) EC / List no: - \| CAS no: 112077-84-6 Hydrazinium(2+) sulphate EC / List no: 233-110-4 \| CAS no: 10034-93-2 Hydrazine, phosphate EC / List no: - \| CAS no: 23488-13-3 Thiocyanic acid, compd. with hydrazine (1:1) EC / List no: - \| CAS no: 24786-78-5 Hydrazine, hydriodide (3:2) EC / List no: - \| CAS no: 10034-92-1 Nitroformic acid, compound with hydrazine (1:1) EC / List no: 244-023-6 \| CAS no: 20773-28-8 Hydrazine, phosphate (2:1) EC / List no: - \| CAS no: 59779-45-2 Hydrazine, hydrochloride EC / List no: - \| CAS no: 14011-37-1 1,2,4-triazolidine-3,5-dione, compound with hydrazine (1:1) EC / List no: 264-246-2 \| CAS no: 63467-96-9 Dihydrazinium sulphate EC / List no: 236-688-6 \| CAS no: 13464-80-7 Hydrazinium bromide EC / List no: 237-412-7 \| CAS no: 13775-80-9 Hydrazine selenate EC / List no: - \| CAS no: 73506-32-8 Hydrazine, monohydrofluoride EC / List no: - \| CAS no: 18220-64-9	-	-	Carc. 1B; Acute Tox. 3; Skin Sens. 1
salts of fenoprop; salts of 2-(2,4,5-trichlorophenoxy)propionic acid	-	-	Acute Tox. 4
salts of ephedrine	-	-	Acute Tox. 4
salts of dinitrophenol	-	-	Acute Tox. 3; STOT RE 2
salts of dichlorprop	-	-	Acute Tox. 4
salts of bromoxynil with the exception of those specified elsewhere in this Annex show/hide Sodium 3,5-dibromo-4-hydroxyphenylcyanide EC / List no: 220-997-8 \| CAS no: 2961-67-3 Potassium 3,5-dibromo-4-hydroxyphenylcyanide EC / List no: 220-998-3 \| CAS no: 2961-68-4	-	-	Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
salts of biphenyl-4-ylamine; salts of xenylamine; salts of 4-aminobiphenyl	-	-	Carc. 1A; Acute Tox. 4
salts of benzidine	252-984-8	36341-27-2	Carc. 1A; Acute Tox. 4
salts of benzidine	244-236-4	21136-70-9	Carc. 1A; Acute Tox. 4
salts of benzidine	208-520-1	531-86-2	Carc. 1A; Acute Tox. 4
salts of benzidine	208-519-6	531-85-1	Carc. 1A; Acute Tox. 4
salts of atropine	-	-	Acute Tox. 2
salts of aniline show/hide Anilinium dihydrogen phosphate EC / List no: 253-680-8 \| CAS no: 37832-42-1 Anilinium p-tolylsulphonate EC / List no: 237-870-8 \| CAS no: 14034-57-2 Anilinium acetate EC / List no: 208-802-4 \| CAS no: 542-14-3 Phthalic acid, compound with aniline (1:1) EC / List no: 256-856-2 \| CAS no: 50930-79-5 Anilinium bromide EC / List no: 208-801-9 \| CAS no: 542-11-0 Benzenesulfonic acid, 2(or 4)-methyl-, compd. with benzenamine (1:1) EC / List no: - \| CAS no: 70788-38-4 Anilinium chloride EC / List no: 205-519-8 \| CAS no: 142-04-1 Anilinetrifluoroboron EC / List no: 211-539-8 \| CAS no: 660-53-7 Benzenesulfonic acid, 2,2'-dithiobis(5-methyl-, compd. with benzenamine (1:2) EC / List no: - \| CAS no: 63468-80-4 Aniline EC / List no: 200-539-3 \| CAS no: 62-53-3 Dianilinium sulphate EC / List no: 208-805-0 \| CAS no: 542-16-5	-	-	Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
salts of aconitine	-	-	Acute Tox. 2
salts of 4,4'-carbonimidoylbis[N, N-dimethylaniline] show/hide Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, mono(dodecylbenzenesulfonate) EC / List no: - \| CAS no: 82794-01-2 4,4'-carbonimidoylbis(N,N-dimethylaniline) monohydrochloride EC / List no: 219-567-2 \| CAS no: 2465-27-2 4,4'-carbonimidoylbis[N,N-dimethylanilinium] sulphate EC / List no: 282-562-9 \| CAS no: 84255-16-3 4,4'-bis[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo][1,1'-biphenyl]-2,2'-disulphonic acid, compound with 4,4'-carbonimidoylbis[N,N-dimethylphenylamine] (1:2) EC / List no: 277-106-0 \| CAS no: 72939-51-6 4,4'-carbonimidoylbis[N,N-dimethylaniline] nitrate EC / List no: 282-561-3 \| CAS no: 84255-15-2 Decyl hydrogen sulphate, compound with 4,4'-carbonimidoylbis[N,N-dimethylaniline] (1:1) EC / List no: 281-828-1 \| CAS no: 84030-53-5 Benzenesulfonic acid, 4-dodecyl-, compd. with 4,4'-carbonimidoylbis(N,N-dimethylbenzenamine) (1:1) EC / List no: - \| CAS no: 63589-43-5 4,4'-carbonimidoylbis[N,N-dimethylaniline] acetate EC / List no: 225-801-4 \| CAS no: 5089-20-3 Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, monohydrochloride, (2-methoxyethoxy)acetate EC / List no: - \| CAS no: 82941-28-4 Methanaminium, N-(4-(amino(4-(dimethylamino)phenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-methyl-, dodecyl(sulfophenoxy)benzenesulfonate (2:1) EC / List no: - \| CAS no: 63428-09-1 Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, monohydrochloride, 2-hydroxyethanesulfonate EC / List no: - \| CAS no: 86157-51-9	-	-	Carc. 2; Acute Tox. 4; Eye Irrit. 2
salts of 4,4'-bi-o-toluidine; salts of 3,3'-dimethylbenzidine; salts of o-tolidine	277-985-0	74753-18-7	Carc. 1B; Acute Tox. 4
salts of 4,4'-bi-o-toluidine; salts of 3,3'-dimethylbenzidine; salts of o-tolidine	265-294-7	64969-36-4	Carc. 1B; Acute Tox. 4
salts of 4,4'-bi-o-toluidine; salts of 3,3'-dimethylbenzidine; salts of o-tolidine	210-322-5	612-82-8	Carc. 1B; Acute Tox. 4
salts of 3,3'-dimethoxybenzidine; salts of o-dianisidine show/hide [1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, bis(2-hydroxy-3,5-dinitrobenzoate) EC / List no: - \| CAS no: 92415-49-1 [1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, mono(3,5-dinitrobenzoate) EC / List no: - \| CAS no: 92415-53-7 (1,1'-Biphenyl)-4,4'-diamine, 3,3'-dimethoxy-, sulfate EC / List no: - \| CAS no: 56436-30-7 (1,1'-Biphenyl)-4,4'-diamine, 3,3'-dimethoxy-, monohydrochloride EC / List no: - \| CAS no: 111984-09-9 3,3'-dimethoxybiphenyl-4,4'-ylenediammonium dichloride EC / List no: 243-737-5 \| CAS no: 20325-40-0 [1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, bis(3,5-dinitrobenzoate) EC / List no: - \| CAS no: 92415-38-8 [1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, mono(2-hydroxy-3,5-dinitrobenzoate) EC / List no: - \| CAS no: 92415-48-0	-	-	Carc. 1B; Acute Tox. 4
salts of 3,3'-dichlorobenzidine; salts of 3,3'-dichlorobiphenyl-4,4'-ylenediamine	-	-	Carc. 1B; Acute Tox. 4; Skin Sens. 1
salts of 2-naphthylamine	210-313-6	612-52-2	Carc. 1A; Acute Tox. 4
salts of 2-naphthylamine	209-030-0	553-00-4	Carc. 1A; Acute Tox. 4
salts of 2,4-DB	-	-	Acute Tox. 4; Eye Dam. 1
salts of 2,4-D show/hide Tris(2-hydroxyethyl)ammonium (o,p-dichlorophenoxy)acetate EC / List no: 219-911-1 \| CAS no: 2569-01-9 Tetradecylammonium (o,p-dichlorophenoxy)acetate EC / List no: 249-156-3 \| CAS no: 28685-18-9 1-[bis(2-hydroxypropyl)amino]propan-2-ol;2-(2,4-dichlorophenoxy)acetic acid EC / List no: 639-766-1 \| CAS no: 18584-79-7 Sodium 2,4-dichlorophenoxyacetate EC / List no: 220-290-4 \| CAS no: 2702-72-9 Dodecylammonium (o,p-dichlorophenoxy)acetate EC / List no: 218-660-5 \| CAS no: 2212-54-6 Trimethylammonium 2,4-dichlorophenoxyacetate EC / List no: 229-132-9 \| CAS no: 6416-73-5 Zinc bis[(2,4-dichlorophenoxy)acetate] EC / List no: 250-495-4 \| CAS no: 31166-17-3 Diethylammonium (o,p-dichlorophenoxy)acetate EC / List no: 244-120-3 \| CAS no: 20940-37-8 Ammonium 2,4-dichlorophenoxyacetate EC / List no: 218-986-8 \| CAS no: 2307-55-3 Acetic acid, (2,4-dichlorophenoxy)-, copper(2) salt EC / List no: - \| CAS no: 63034-89-9 2,4-D-lithium EC / List no: 693-035-1 \| CAS no: 3766-27-6 (2,4-Dichlorophenoxy)acetic acid triethylamine salt EC / List no: - \| CAS no: 2646-78-8 (2,4-Dichlorophenoxy)acetic acid isopropylamine salt EC / List no: 690-142-5 \| CAS no: 5742-17-6 (2-hydroxyethyl)ammonium (o,p-dichlorophenoxy)acetate EC / List no: 222-752-0 \| CAS no: 3599-58-4 Potassium (2,4-dichlorophenoxy)acetate EC / List no: 238-070-1 \| CAS no: 14214-89-2 Aluminium tris(2,4-dichlorophenoxyacetate) EC / List no: 250-497-5 \| CAS no: 31166-18-4 Acetic acid, (2,4-dichlorophenoxy)-, compd. with 2-[2-[2-(octadecylamino)ethoxy]ethoxy]ethanol(1:1) EC / List no: - \| CAS no: 37937-04-5 Dimethylammonium 2,4-dichlorophenoxyacetate EC / List no: 217-915-8 \| CAS no: 2008-39-1 Bis(2-hydroxyethyl)ammonium 2,4-dichlorophenoxyacetate EC / List no: 227-256-8 \| CAS no: 5742-19-8	-	-	Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Salts of 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid	-	-			yes
salts of 2,2'-dichloro-4,4'-methylenedianiline; salts of 4,4'-methylenebis(2-chloroaniline)	-	-	Carc. 1B; Acute Tox. 4
salts and esters of MCPB	-	-	Acute Tox. 4
salts and esters of MCPA	-	-	Acute Tox. 4
salts and esters of dinoterb show/hide 2-tert-butyl-4,6-dinitrophenyl acetate EC / List no: 221-706-7 \| CAS no: 3204-27-1	-	-	Repr. 1B; Acute Tox. 2; Acute Tox. 3
salts and esters of dinoseb, with the exception of those specified elsewhere in this Annex show/hide Dinoseb acetate EC / List no: 220-560-1 \| CAS no: 2813-95-8 Sodium 2-(1-methylpropyl)-4,6-dinitrophenolate EC / List no: 252-331-7 \| CAS no: 35040-03-0 Ammonium 2-sec-butyl-4,6-dinitrophenolate EC / List no: 228-858-3 \| CAS no: 6365-83-9 2-sec-butyl-4,6-dinitrophenol, compound with 1-aminopropan-2-ol (1:1) EC / List no: 275-931-0 \| CAS no: 71735-19-8 2-sec-butyl-4,6-dinitrophenol, compound with 2,2'-iminodiethanol (1:1) EC / List no: 258-532-6 \| CAS no: 53404-43-6 Binapacryl EC / List no: 207-612-9 \| CAS no: 485-31-4 2-sec-butyl-4,6-dinitrophenol, compound with 2,2',2''-nitrilotriethanol (1:1) EC / List no: 229-166-4 \| CAS no: 6420-47-9	-	-	Repr. 1B; Acute Tox. 3; Eye Irrit. 2
salts and esters of dinosam	-	-	Acute Tox. 3
salts and esters of dinex	-	-	Acute Tox. 3
salts and esters of 2,4,5-T; salts and esters of 2,4,5-trichlorophenoxy acetic acid	-	-	Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
salt of: (1S-cis)-1-amino-2,3-dihydro-1H-inden-2-ol and [R-[RR]]-2,3-dihydroxybutanedioic acid	425-210-3	169939-84-8	Skin Sens. 1
Salmonella typhimurium	-	68583-35-7		B Bacteria and similar species
Salmonella typhi	-	-		B Bacteria and similar species
Salmonella paratyphi A, B, C	-	-		B Bacteria and similar species
Salmonella enteritidis	-	-		B Bacteria and similar species
Salmonella arizonae	-	-		B Bacteria and similar species
Salmonella (other serovars)	-	-		B Bacteria and similar species
salicylic acid	200-712-3	69-72-7	Repr. 2; Acute Tox. 4; Eye Dam. 1
safrole; 5-allyl-1,3-benzodioxole	202-345-4	94-59-7	Carc. 1B; Muta. 2; Acute Tox. 4
Sabia 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.
sabadilla (ISO);veratrine	617-100-0	8051-02-3	Eye Irrit. 2; STOT SE 3; Skin Irrit. 2

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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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