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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 March 2023. Database contains 4753 unique substances/entries.

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Showing 1 - 50 of 4,753 results.

Substance Name	EC No.	CAS No.	EU CLP (1272/2008)	EU_BA Directive 2000/54/EC	EU REACH: List of SVHC
ε-caprolactam	203-313-2	105-60-2	Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
α[2-[[[(2-hydroxyethyl)methylamino]acetyl]amino]propyl]-ω nonylphenoxy)poly[oxo(methyl-1,2-ethanediyl)] PC-709	413-420-8	144736-29-8	Skin Corr. 1B; Skin Sens. 1
α-hydroxypoly(methyl-(3-(2,2,6,6-tetramethylpiperidin-4-yloxy)propyl)siloxane)	639-478-6	182635-99-0	Acute Tox. 4; Skin Corr. 1B
α-cypermethrin (ISO); racemate comprising (R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate; (S)-α-cyano-3-phenoxybenzyl(1R, 3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate	614-054-3	67375-30-8	Acute Tox. 3; STOT RE 2; STOT SE 3
α-chlorotoluene; benzyl chloride	202-853-6	100-44-7	Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
α-bromotoluene; benzyl bromide	202-847-3	100-39-0	Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
α-[3-(1-oxoprop-2-enyl)l-1-oxypropyl]dimethoxysilyloxy-ω-[3(1-oxoprop-2-enyl)-1-oxypropyl]dimethoxysilyl poly(dimethylsiloxane) ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE	415-290-8	193159-06-7	Skin Sens. 1
α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol; C.I. Solvent Blue 4	229-851-8	6786-83-0			yes
α, α-dimethylbenzyl hydroperoxide; cumene hydroperoxide	201-254-7	80-15-9	Org. Perox. E; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
α, α-dichlorotoluene; benzylidene chloride; benzal chloride	202-709-2	98-87-3	Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
α, α, α-trifluorotoluene; benzotrifluoride	202-635-0	98-08-8	Flam. Liq. 2
α, α, α-trichlorotoluene; benzotrichloride	202-634-5	98-07-7	Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
α, α, α,4-tetrachlorotoluene; p-chlorobenzotrichloride	226-009-1	5216-25-1	Carc. 1B; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
zoxamide (ISO); (RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide	605-037-1	156052-68-5	Skin Sens. 1
zirconium powder (pyrophoric);zirconium powder, dry (non pyrophoric)	231-176-9	7440-67-7	Water-react. 1; Pyr. Sol. 1
zirconium powder (pyrophoric);zirconium powder, dry (non pyrophoric)	231-176-9	7440-67-7	Self-heat. 1
Zirconia Aluminosilicate Refractory Ceramic Fibres are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.1 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and fulfil the three following conditions: a) oxides of aluminium, silicon and zirconium are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (µm). c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight show/hide Refractories, fibers, aluminosilicate EC / List no: 604-314-4 \| CAS no: 142844-00-6	-	-			yes
ziram (ISO); zinc bis dimethyldithiocarbamate	205-288-3	137-30-4	Acute Tox. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
zineb (ISO); zinc ethylenebis(dithiocarbamate) (polymeric)	235-180-1	12122-67-7	STOT SE 3; Skin Sens. 1
zinc-bis(4-(n-octyloxycarbonylamino)salicylate) dihydrate	417-130-2	1379689-21-0	Eye Dam. 1
zinc sulphate (hydrous) (mono-, hexa-and hepta hydrate)	616-096-8	7446-19-7	Acute Tox. 4; Eye Dam. 1
zinc sulphate (anhydrous)	231-793-3	7733-02-0	Acute Tox. 4; Eye Dam. 1
zinc powder — zinc dust (pyrophoric)	231-175-3	7440-66-6	Water-react. 1; Pyr. Sol. 1
zinc hexacyanocobaltate(III), tertiary butyl alcohol/polypropylene glycol complex	425-240-7	-	Eye Dam. 1
zinc chromates including zinc potassium chromate show/hide Pentazinc chromate octahydroxide EC / List no: 256-418-0 \| CAS no: 49663-84-5 Zinc chromate EC / List no: 236-878-9 \| CAS no: 13530-65-9 Zinc chromate oxide (Zn2(CrO4)O), monohydrate EC / List no: - \| CAS no: 15930-94-6 Zinc dichromate EC / List no: 237-843-0 \| CAS no: 14018-95-2 Potassium hydroxyoctaoxodizincatedichromate(1-) EC / List no: 234-329-8 \| CAS no: 11103-86-9 Chromic acid, potassium zinc salt EC / List no: 255-252-6 \| CAS no: 41189-36-0 C.I. Pigment Yellow 36 EC / List no: 609-398-6 \| CAS no: 37300-23-5	-	-	Carc. 1A; Acute Tox. 4; Skin Sens. 1
zinc chloride	231-592-0	7646-85-7	Acute Tox. 4; Skin Corr. 1B
zinc bis(diethyldithiocarbamate)	238-270-9	14324-55-1	Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
zinc bis(dibutyldithiocarbamate)	205-232-8	136-23-2	Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
zinc 2-hydroxy-5-C13-18 alkylbenzoate Z-6	402-280-3	149144-82-1	Eye Irrit. 2; Skin Irrit. 2
Yersinia spp.	-	-		B Bacteria and similar species
Yersinia pseudotuberculosis	-	-		B Bacteria and similar species
Yersinia pestis	-	-		B Bacteria and similar species
Yersinia enterocolitica	-	-		B Bacteria and similar species
Yellow fever	-	-		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.
Yatapox 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.
xylylcarb (ISO); 3,4-dimethylphenyl N-methylcarbamate; 3,4-xylyl methylcarbamate; MPMC	219-364-9	2425-10-7	Acute Tox. 4
xylidines with the exception of those specified elsewhere in this Annex; dimethyl anilines with the exception of those specified elsewhere in this Annex	215-091-4	1300-73-8	Acute Tox. 3; STOT RE 2
xylenol	215-089-3	1300-71-6	Acute Tox. 3; Skin Corr. 1B
xylene	215-535-7	1330-20-7	Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
XMC; 3,5-xylyl methylcarbamate	607-955-8	2655-14-3	Acute Tox. 4
Wuchereria bancrofti	-	-		P Parasites
Whitepox 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.
white phosphorus	601-810-2	12185-10-3	Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
Western equine encephalomyelitis	-	-		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.
West Nile fever 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.
Wesselsbron 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.
Waste solids, coal-tar pitch coking; Coal Tar Solids Residue [The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.] The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.	295-549-8	92062-34-5	Carc. 1B
warfarin (ISO); 4-hydroxy-3-(3-oxo-1-phenylbutyl)-2H-chromen-2-one;	201-377-6	81-81-2	Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
vinyl chloride; chloroethylene	200-831-0	75-01-4	Press. Gas; Flam. Gas 1; Carc. 1A
vinyl acetate	203-545-4	108-05-4	Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 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 24 March 2023. Database contains 4753 unique substances/entries.

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