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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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.

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Last updated 18 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
Nonylphenol, ethoxylated (EO = 10)
939-993-9
-
yes
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP)
939-460-0
1471311-26-8
yes
Nonylphenol, ethoxylated (polymer)
938-618-6
-
yes
Zirconia Aluminosilicate Refractory Ceramic Fibres
936-037-2
-
yes
proteases with the exception of those specified elsewhere in this Annex
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Proteinase, Bacillus polymyxa neutral EC / List no: 255-914-4 | CAS no: 42613-33-2
Proteinase, serine EC / List no: 253-431-3 | CAS no: 37259-58-8
Proteinase, Bothrops atrox serine EC / List no: 232-918-4 | CAS no: 9039-61-6
Proteinase, microbial acid EC / List no: 256-862-5 | CAS no: 50936-52-2
Amylase, mixed with proteinase, Bacillus thuringiensis-fermented EC / List no: - | CAS no: 68909-36-4
Proteinase, Aspergillus neutral EC / List no: 278-588-5 | CAS no: 77000-13-6
Proteinase, aspartic EC / List no: 278-856-1 | CAS no: 78169-47-8
Proteinase, Bacillus neutral EC / List no: 278-547-1 | CAS no: 76774-43-1
Proteinase, Agkistrodon serine EC / List no: 232-933-6 | CAS no: 9046-56-4
Proteinase, Endothia aspartic EC / List no: 253-395-9 | CAS no: 37205-60-0
Proteinase, Aspergillus niger neutral EC / List no: 254-422-7 | CAS no: 39346-39-9
Proteinase, rhizopus acid EC / List no: 812-486-9 | CAS no: 9074-09-3
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Bacillus megaterium protease fermentation product EC / List no: - | CAS no: 68909-17-1
Proteinase, Streptomyces griseus EC / List no: 232-909-5 | CAS no: 9036-06-0
Proteinase, Myxobacter α-lytic EC / List no: 253-448-6 | CAS no: 37288-76-9
Proteinase, Bacillus subtilis EC / List no: 257-520-8 | CAS no: 51931-23-8
Proteinase, submandibular gland serine, A EC / List no: 279-893-6 | CAS no: 82047-85-6
Aspergillin M EC / List no: - | CAS no: 42615-60-1
Proteinase, Bacillus subtilis metallo- EC / List no: 232-991-2 | CAS no: 9080-56-2
Proteinase, Myxobacter AL-1, II EC / List no: 276-716-4 | CAS no: 72561-05-8
Proteinase, microbial alkaline EC / List no: 256-863-0 | CAS no: 50936-53-3
Myxobacteralphalyticproteinase EC / List no: - | CAS no: 12585-31-8
Proteinase, Aspergillus oryzae neutral EC / List no: 232-990-7 | CAS no: 9080-55-1
Proteinase, Mucor aspartic EC / List no: 232-975-5 | CAS no: 9073-79-4
Proteinase, Bacillus subtilis serine EC / List no: 266-557-9 | CAS no: 67051-83-6
Proteinase, Staphylococcus aureus serine EC / List no: 259-611-8 | CAS no: 55354-32-0
Proteinase, bacterial E 30 serine EC / List no: - | CAS no: 39369-34-1
Proteinase, oryzin EC / List no: 232-992-8 | CAS no: 9081-30-5
Proteinase, Aspergillus parasiticus neutral EC / List no: 254-418-5 | CAS no: 39335-09-6
Proteinase, Bacillus subtilis, sutilain EC / List no: 235-390-3 | CAS no: 12211-28-8
Proteinase, Aspergillus alkaline EC / List no: 232-977-6 | CAS no: 9074-07-1
Proteinase, Aspergillus melleus, semialkaline EC / List no: - | CAS no: 76106-83-7
Proteinase, Bacillus alcalophilus serine EC / List no: 306-090-0 | CAS no: 95979-76-3
Proteinase, microbial neutral EC / List no: 232-966-6 | CAS no: 9068-59-1
Proteinase, Aspergillus acid EC / List no: 232-796-2 | CAS no: 9025-49-4
Proteinase, pancreatic EC / List no: 232-626-7 | CAS no: 9001-72-3
Proteinase, serine (Tritirachium album) EC / List no: 686-165-5 | CAS no: 102925-54-2
Proteinase, Bacillus licheniformis serine EC / List no: 279-361-3 | CAS no: 79986-26-8
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Proteinase, Bacillus alkaline EC / List no: 232-972-9 | CAS no: 9073-77-2
Thrombin EC / List no: 232-648-7 | CAS no: 9002-04-4
Proteinase, Serratia extracellular EC / List no: 253-457-5 | CAS no: 37312-62-2
Proteinase, Tritirachium album serine EC / List no: 254-457-8 | CAS no: 39450-01-6
934-013-6
39450-01-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Nonylphenolpolyglycolether
932-998-7
-
yes
Nonylphenol, ethoxylated (15-EO) (9016-45-9)
931-756-8
-
yes
Nonylphenol, ethoxylated (10-EO) (9016-45-9)
931-755-2
-
yes
Nonylphenol, ethoxylated (8-EO) (9016-45-9)
931-754-7
-
yes
Nonylphenol, ethoxylated (6,5-EO) (9016-45-9)
931-753-1
-
yes
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate; reaction mass of DOTE and MOTE
915-270-3
-
yes
(2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol; mefentrifluconazole
822-682-6
1417782-03-6
Skin Sens. 1
(RS)-4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole; medetomidine
811-718-6
86347-14-0
Acute Tox. 2; STOT SE 3; STOT SE 1; STOT RE 1
sulfoxaflor (ISO); [methyl(oxo) {1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ6-sulfanylidene]cyanamide
807-366-8
946578-00-3
Acute Tox. 4
4-{[(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amino}furan-2(5H)-one; flupyradifurone
804-373-8
951659-40-8
Acute Tox. 4; STOT RE 2
Tris(4-nonylphenyl, branched) phosphite
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Phenol, p-isononyl-, phosphite (3:1) EC / List no: - | CAS no: 31631-13-7
Phenol, p-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
Phenol, 4-nonyl-, phosphite (3:1) EC / List no: 608-492-4 | CAS no: 3050-88-2
tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 | CAS no: -
Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
799-976-5
-
yes
Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety
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dioctyltin dilaurate; stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: - | CAS no: -
Stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: 293-901-5 | CAS no: 91648-39-4
Dioctyltin dilaurate EC / List no: 222-883-3 | CAS no: 3648-18-8
799-973-9
-
yes
metaflumizone (ISO); (EZ)-2-[2-(4-cyanophe-nyl)-1-(a,a,a -trifluoro-m-tolyl)ethylidene]-[4-(tri-fluoromethoxy)phenyl] carbanilohydrazide [E-iso-mer > 90 %, Z-isomer <10 % relative content]; [1] (E)-2-[2-(4-cyanophenyl)-1-(a,a,a -trifluoro-m-tolyl) ethylidene]-[4-(trifluoro-methoxy)phenyl]carbani-lohydrazide [2]
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 2
phenol, 3-dodecyl-, branched
701-107-1
1801269-77-1
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
phenol, 2-dodecyl-, branched
701-105-0
1801269-80-6
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate
700-242-3
62037-80-3
yes
2-methyl-1,2-benzothiazol-3(2H)-one; [MBIT]
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide
691-719-4
1072957-71-1
Acute Tox. 3
2-{2-[4-(3,6-dimethylheptan-3-yl)phenoxy]ethoxy}ethanol
687-833-9
1119449-38-5
yes
2-[4-(3,6-dimethylheptan-3-yl)phenoxy]ethanol
687-832-3
1119449-37-4
yes
di-L-para-menthene
686-814-2
34363-01-4
Skin Irrit. 2; Skin Sens. 1
tetracopper hexahydroxide sulphate hydrate
682-362-5
12527-76-3
Acute Tox. 4
amisulbrom (ISO); 3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
cyflumetofen (ISO); 2-methoxyethyl (RS)-2-(4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate
642-974-5
400882-07-7
Carc. 2; Skin Sens. 1A
hydroxyisohexyl 3-cyclohexene carboxaldehyde (INCI); reaction mass of 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
641-410-5
130066-44-3
Skin Sens. 1A
Cadmium chloride, hydrate (2:5)
640-998-0
7790-78-5
yes
phenol, 4-dodecyl-, branched
640-104-9
210555-94-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 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
4-(3-ethylheptan-2-yl)phenol
635-696-0
186825-39-8
yes
4-(3,6-dimethylheptan-3-yl)phenol
635-391-2
142731-63-3
yes
4-(3,5-dimethylheptan-3-yl)phenol
635-389-1
186825-36-5
yes
4-(2,6-dimethylheptan-2-yl)phenol
635-388-6
521947-27-3
yes
pinoxaden (ISO); 8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
methacrifos (ISO); methyl (E)-3-[(dimethoxyphosphinothioyl)oxy]methacrylate
630-448-8
62610-77-9
Acute Tox. 4; Skin Sens. 1
Sulphuric acid, cadmium salt (1:1), unspecified hydration rate
626-360-4
15244-35-6
yes
4-tert-Octylphenol monoethoxylate
621-345-9
2315-67-5
yes
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated
621-341-7
2315-61-9
yes
erionite
620-440-2
12510-42-8
Carc. 1A
diclobutrazole (ISO);(R*, R*)-(±)-β-[(2,4-dichlorop henyl)methyl]-α-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol; (2RS, 3RS)-1-(2,4-dichlorophenyl)-4,4-dimethyl-2- (1H—1,2,4-triazol-1yl)pentan-3-ol
620-436-0
75736-33-3
Eye Irrit. 2
propylenethiourea
620-432-9
2122-19-2
Repr. 2; Acute Tox. 4
guazatine (ISO)
620-427-1
108173-90-6
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
azafenidin (ISO); 2-(2,4-dichloro-5-prop-2-ynyloxyphenyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyridine-3(2H)-one
620-425-0
68049-83-2
Repr. 1B; STOT RE 2
dinosam (ISO); 2-(1-methylbutyl)-4,6-dinitrophenol
620-422-4
4097-36-3
Acute Tox. 3
2,4,6-trinitroanisole
620-419-8
606-35-9
Expl. 1.1; Acute Tox. 4
8,9-dinorborn-5-ene-2,3-dicarboxylic anhydride
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
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