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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 10 maja 2024. Database contains 4753 unique substances/entries.

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Wyświetlanie 1 401 - 1 500 z 4 753 rezultatów.

Substance Name	EC No.	CAS No.	EU CLP (1272/2008)	EU_BA Directive 2000/54/EC	EU REACH: List of SVHC
bis-(6-hydroxy-4-methyl-5-(3-methylimidazolium-1-yl)-3-(4-phenylazo)-1H-pyridin-2-one)ethylene dilactate	421-560-6	-	STOT RE 2; Eye Dam. 1
bis-[4-(2,3-epoxipropoxi)phenyl]propane	216-823-5	1675-54-3	Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
bis[(1-methylimidazol)-(2-ethyl-hexanoate)], zinc complex TK 10891; XB 4458; XW 528; ZK XB 4458	405-635-0	-	Skin Irrit. 2; Eye Dam. 1
bis[4-(ethenyloxy)butyl] 1,3-benzenedicarboxylate VECTOMER E2200	413-930-0	130066-57-8	Skin Sens. 1
bis[[2,2',2''-nitrilotris-[ethanolato]]-1-N,O]-bis[2-(2-methoxyethoxy)ethoxy]-titanium TITANCHELAT ETAM	410-500-4	357921-97-2	Eye Dam. 1
bis[tributyl 4-(methylbenzyl)ammonium] 1,5-naphthalenedisulfonate MCP-304	415-210-1	160236-81-7	Acute Tox. 4; Eye Dam. 1
bisphenol A; 4,4'-isopropylidenediphenol	201-245-8	80-05-7	Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1		yes
BK and JC viruses	-	-		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.
Blastomyces dermatitidis	-	-		F Fungi
Borate(2-), tetrahydroxybis[μ-(peroxy-κO1:κO2)]di-, sodium (1:2)	-	90568-23-3			yes
Borate(2-), tetrahydroxybis[μ-(peroxy-κO1:κO2)]di-, sodium, hydrate (1:2:6)	-	125022-34-6			yes
bordeaux mixture; reaction products of copper sulphate with calcium dihydroxide	616-932-1	8011-63-0	Acute Tox. 4; Eye Dam. 1
Bordetella bronchiseptica	-	-		B Bacteria and similar species
Bordetella parapertussis	-	-		B Bacteria and similar species
Bordetella pertussis	-	-		B Bacteria and similar species
boric acid	233-139-2	10043-35-3	Repr. 1B		yes
boric acid	234-343-4	11113-50-1	Repr. 1B		yes
boron tribromide	233-657-9	10294-33-4	Acute Tox. 2; Skin Corr. 1A
boron trichloride	233-658-4	10294-34-5	Press. Gas; Acute Tox. 2; Skin Corr. 1B
boron trifluoride	231-569-5	7637-07-2	Press. Gas; Acute Tox. 2; Skin Corr. 1A
Borrelia burgdorferi	-	-		B Bacteria and similar species
Borrelia duttonii	-	-		B Bacteria and similar species
Borrelia recurrentis	-	-		B Bacteria and similar species
Borrelia spp.	-	-		B Bacteria and similar species
Bovine spongiform encephalopathy (BSE) and other related animal TSEs	-	-		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.
bromadiolone (ISO); 3-[3-(4'-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H-chromen-2-one	249-205-9	28772-56-7	Repr. 1B; Acute Tox. 1; STOT RE 1
bromelain, juice	232-572-4	9001-00-7	Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
bromine	231-778-1	7726-95-6	Acute Tox. 2; Skin Corr. 1A
bromoacetic acid	201-175-8	79-08-3	Acute Tox. 3; Skin Corr. 1A; Skin Sens. 1
bromobenzene	203-623-8	108-86-1	Flam. Liq. 3; Skin Irrit. 2
bromobenzylbromotoluene, reaction mass of isomers DBBT	402-210-1	99688-47-8	STOT RE 2; Skin Sens. 1
bromoethane; ethyl bromide	200-825-8	74-96-4	Flam. Liq. 2; Carc. 2; Acute Tox. 4
bromoethylene	209-800-6	593-60-2	Press. Gas; Flam. Gas 1; Carc. 1B
bromofenoxim (ISO); 3,5-dibromo-4-hydroxybenzaldehyde-O-(2,4-dinitrophenyl)-oxime	236-129-6	13181-17-4	Acute Tox. 4
bromoform; tribromomethane	200-854-6	75-25-2	Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
bromomethane; methylbromide	200-813-2	74-83-9	Press. Gas; Muta. 2; Acute Tox. 3; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
bromophos (ISO); O-4-bromo-2,5-dichlorophenyl O,O-dimethyl phosphorothioate	218-277-3	2104-96-3	Acute Tox. 4
bromophos-ethyl (ISO); O-4-bromo-2,5-dichlorophenyl; O,O-diethyl phosphorothioate	225-399-0	4824-78-6	Acute Tox. 3; Acute Tox. 4
bromoxynil (ISO) 3,5-dibromo-4-hydroxybenzonitrile; bromoxynil phenol show/hide 2,6-dibromo-4-cyanophenyl octanoate EC / List no: 216-885-3 \| CAS no: 1689-99-2 2,6-dibromo-4-cyanophenyl heptanoate EC / List no: 260-300-4 \| CAS no: 56634-95-8 3,5-dibromo-4-hydroxybenzonitrile EC / List no: 216-882-7 \| CAS no: 1689-84-5 2,6-dibromo-4-cyanophenyl butyrate EC / List no: 223-374-9 \| CAS no: 3861-41-4	216-882-7	1689-84-5	Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
bromoxynil heptanoate (ISO); 2,6-dibromo-4-cyanophenyl heptanoate	260-300-4	56634-95-8	Repr. 2; Acute Tox. 4; Skin Sens. 1
bromoxynil octanoate (ISO); 2,6-dibromo-4-cyanophenyl octanoate	216-885-3	1689-99-2	Repr. 2; Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
bronopol (INN); 2-bromo-2-nitropropane-1,3-diol	200-143-0	52-51-7	Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Brucella abortus	-	-		B Bacteria and similar species
Brucella canis	-	-		B Bacteria and similar species
Brucella melitensis	-	-		B Bacteria and similar species
Brucella suis	-	-		B Bacteria and similar species
brucine nitrate	227-317-9	5786-97-0	Acute Tox. 2
brucine sulphate	225-432-9	4845-99-2	Acute Tox. 2
brucine; 2,3-dimethoxystrychnine	206-614-7	357-57-3	Acute Tox. 2
Brugia malayi	-	-		P Parasites
Brugia pahangi	-	-		P Parasites
bufa-4,20,22-trienolide, 6-(acetyloxy)-3-(β-D-glucopyranosyloxy)-8,14-dihydroxy-, (3β, 6β)-; red squill; scilliroside	208-077-4	507-60-8	Acute Tox. 2
bufencarb (ISO); reaction mass of 3-(1-methylbutyl)phenyl N-methylcarbamate and 3-(1-ethylpropyl)phenyl N-methylcarbamate	620-359-2	8065-36-9	Acute Tox. 3
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.
bunsenite	-	34492-97-2	Carc. 1A; STOT RE 1; Skin Sens. 1
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.
bupirimate (ISO); 5-butyl-2-ethylamino-6-methylpyrimidin-4-yl dimethylsulphamate	255-391-2	41483-43-6	Carc. 2; Skin Sens. 1B
Burkholderia mallei	-	-		B Bacteria and similar species
Burkholderia pseudomallei	-	-		B Bacteria and similar species
but-1-ene	203-449-2	106-98-9	Flam. Gas 1; Press. Gas
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
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
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
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
butanone; ethyl methyl ketone	201-159-0	78-93-3	Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
butene, mixed-1-and-2-isomers	203-452-9	107-01-7	Flam. Gas 1; Press. Gas
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
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
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
Butyl 4-hydroxybenzoate	202-318-7	94-26-8			yes
butyl butyrate	203-656-8	109-21-7	Flam. Liq. 3
butyl chloroformate; chloroformic acid butyl ester	209-750-5	592-34-7	Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
butyl formate	209-772-5	592-84-7	Flam. Liq. 2; Eye Irrit. 2; STOT SE 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 nitrite	208-862-1	544-16-1	Flam. Liq. 2; Acute Tox. 3
butylamine	203-699-2	109-73-9	Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
butyltricyclohexylstannane	230-358-5	7067-44-9	Acute Tox. 4
butyraldehyde	204-646-6	123-72-8	Flam. Liq. 2
butyraldehyde oxime	203-792-8	110-69-0	Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
butyric acid	203-532-3	107-92-6	Skin Corr. 1B
butyryl chloride	205-498-5	141-75-3	Flam. Liq. 2; Skin Corr. 1B
C,C'-azodi(formamide)	204-650-8	123-77-3	Resp. Sens. 1		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			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.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. 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. Solvent Yellow 14; 1-phenylazo-2-naphthol	212-668-2	842-07-9	Carc. 2; Muta. 2; Skin Sens. 1
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
C12-14-tert-alkylamine, methylphosphonic acid salt CD 23-404	404-750-3	119415-07-5	Acute Tox. 4; Skin Corr. 1B
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
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
cadmium carbonate	208-168-9	513-78-0	Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1		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 chloride, hydrate (2:5)	640-998-0	7790-78-5			yes
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 cyanide	208-829-1	542-83-6	Acute Tox. 2; Acute Tox. 1; Carc. 2; STOT RE 2
cadmium diformate; cadmiumformate	224-729-0	4464-23-7	Acute Tox. 3; Carc. 2; STOT RE 2
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 hydroxide; cadmium dihydroxide	244-168-5	21041-95-2	Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1		yes

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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 10 maja 2024. Database contains 4753 unique substances/entries.

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