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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 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
Sin Nombre
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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.
Sindbis virus
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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.
SIV
-
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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.
Slack wax (petroleum), acid-treated; Slack wax [A complex combination of hydrocarbons obtained as a raffinate by treatment of a petroleum slack wax fraction with sulfuric acid treating process. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.]
A complex combination of hydrocarbons obtained as a raffinate by treatment of a petroleum slack wax fraction with sulfuric acid treating process. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
292-659-8
90669-77-5
Carc. 1B
Slack wax (petroleum), carbon-treated; Slack wax [A complex combination of hydrocarbons obtained by treatment of petroleum slack wax with activated charcoal for the removal of trace polar constituents and impurities.]
A complex combination of hydrocarbons obtained by treatment of petroleum slack wax with activated charcoal for the removal of trace polar constituents and impurities.
309-723-9
100684-49-9
Carc. 1B
Slack wax (petroleum), clay-treated; Slack wax [A complex combination of hydrocarbons obtained by treatment of a petroleum slack wax fraction with natural or modified clay in either a contacting or percolation process. It consists predomi nantly of saturated straight and branched hydrocarbons having carbon numbers predominantly greater than C20.]
A complex combination of hydrocarbons obtained by treatment of a petroleum slack wax fraction with natural or modified clay in either a contacting or percolation process. It consists predominantly of saturated straight and branched hydrocarbons having carbon numbers predominantly greater than C20.
292-660-3
90669-78-6
Carc. 1B
Slack wax (petroleum), hydrotreated; Slack wax [A complex combination of hydrocarbons obtained by treating slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.]
A complex combination of hydrocarbons obtained by treating slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
295-523-6
92062-09-4
Carc. 1B
Slack wax (petroleum), low-melting, carbon-treated; Slack wax [A complex combination of hydrocarbons obtained by the treatment of low-melting slack wax with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of low-melting slack wax with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-155-9
97863-04-2
Carc. 1B
Slack wax (petroleum), low-melting, clay-treated; Slack wax [A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with bentonite for removal of trace polar constituents and impur ities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with bentonite for removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-156-4
97863-05-3
Carc. 1B
Slack wax (petroleum), low-melting, hydrotreated; Slack wax [A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predomi nantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-525-7
92062-11-8
Carc. 1B
Slack wax (petroleum), low-melting, silicic acid-treated; Slack wax [A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-158-5
97863-06-4
Carc. 1B
Slack wax (petroleum), low-melting; Slack wax [A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-524-1
92062-10-7
Carc. 1B
Slack wax (petroleum); Slack wax [A complex combination of hydrocarbons obtained from a petroleum fraction by solvent crystallization (solvent dewaxing) or as a distillation fraction from a very waxy crude. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.]
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent crystallization (solvent dewaxing) or as a distillation fraction from a very waxy crude. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
265-165-5
64742-61-6
Carc. 1B
slimes and sludges, copper electrolyte refining, decopperised
Substance obtained as a powdery cathodic precipitate during the electrolytic decoppering stage of copper refining electrolysis. Consists primarily of copper with antimony, arsenic, lead and nickel in metallic form as well as oxides and sulfates.
305-433-1
94551-87-8
Carc. 1A; Muta. 2; Repr. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
slimes and sludges, copper electrolytic refining, decopperised, nickel sulfate
Product obtained from recycling of the end electrolyte of copper refining electrolysis followed by evaporation to separate the residual sulfuric acid. Consists primarily of nickel and iron sulfates with small amounts of the sulfates of zinc, alkali earths and alkali metals.
295-859-3
92129-57-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
sodium
231-132-9
7440-23-5
Water-react. 1; Skin Corr. 1B
sodium ((N-(3-trimethylammoniopropyl)sulfamoyl)methylsulfonatophthalocyaninato)copper(II)
C.I. BASIC BLUE 163
407-340-2
124719-24-0
Eye Dam. 1
sodium (1,0-1,95)/lithium (0,051) 5-((5-((5-chloro-6-fluoro-pyrimidin-4-yl)amino)-2-sulfonatophenyl)azo)-1,2-dihydro-6-hydroxy-1,4-dimethyl-2-oxo-3-pyridinemethylsulfonate
LEVAFIX GELB FC 47859; REACTIVE YELLOW FC 47859
413-470-0
134595-59-8
Skin Sens. 1
sodium (1-(5-(4-(4-anilino-3-sulphophenylazo)-2-methyl-5-methylsulphonamidophenylazo)4-hydroxy-2-oxido-3-(phenylazo)phenylazo)-5-nitro-4-sulphonato-2-naphtholato)iron(II)
SÄUREBRAUN 6230
401-220-3
-
Acute Tox. 4
sodium (6R-trans)-7-amino-8-oxo-3-[[[1-(sulfomethyl)-1H-tetrazol-5-yl]thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monohydrate
426-520-1
71420-85-4
Skin Sens. 1
sodium (n-butyl)x(ethyl)y-1,5-dihydro)aluminate x = 0,5 y =1,5
EURESYNTH(R) 5010
418-720-2
-
Flam. Sol. 1; Water-react. 1; Pyr. Sol. 1; Acute Tox. 4; Skin Corr. 1A
sodium (R)-2-(2,4-dichlorophenoxy)propionate
DUPLOSAN-DP-NATRIUM; DUPOLSON-DP-NATRIUM
413-340-3
119299-10-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
sodium (Z)-3-chloro-3-(4-chlorophenyl)-1-hydroxy-2-propene-1-sulfonate
420-800-7
1379804-37-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
sodium 1,1,2,2,3,3,4,4,4-nonafluoro-1-butanesulfinate
422-100-7
102061-82-5
Eye Dam. 1; Skin Sens. 1
sodium 1,2-bis[4-[4-{4-(4-sulfophenylazo)-2-sulfophenylazo}-2-ureido-phenyl-amino]-6-fluoro-1,3,5-triazin-2-ylamino]-propane, sodium salt
REACTIVE ORANGE TZ 3931
413-990-8
149850-31-7
Skin Sens. 1
sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethonolate; sodium dehydracetate
224-580-1
4418-26-2
Acute Tox. 4
sodium 2-(4-(4-fluoro-6-(2-sulfo-ethylamino)-[1,3,5]triazin-2-ylamino)-2-ureido-phenylazo)-5-(4-sulfophenylazo)benzene-1-sulfonate
FAT 40'436; FAT 40'436/A; REACTIVE ORANGE TZ 3538
410-770-3
146177-84-6
Skin Sens. 1
sodium 2-(nonanoyloxy)benzenesulfonate
434-360-9
91125-43-8
Eye Dam. 1; Skin Sens. 1
sodium 2-[[4-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]phenyl]sulfonyl]ethyl sulfate
430-890-1
81992-66-7
Skin Sens. 1
sodium 2-anilino-5-(2-nitro-4-(N-phenylsulfamoyl))anilinobenzenesulfonate
NSGBB; YELLOW BROWN E-GLN
412-320-1
31361-99-6
Eye Dam. 1
sodium 2-benzoyloxy-1-hydroxyethane-sulfonate
BENZOYL BISULFITE
410-680-4
1379676-76-2
Skin Sens. 1
sodium 2-biphenylate; 2-phenylphenol, sodium salt
205-055-6
132-27-4
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
sodium 2-ethylhexanolate
NA-2-ETHYLHEXANOLAT
406-150-7
38411-13-1
Flam. Sol. 1; Skin Corr. 1B
sodium 3,5-bis(3-(2,4-di-tert-pentylphenoxy)propylcarbamoyl)benzenesulfonate
AF-365
405-510-0
121216-78-2
Skin Irrit. 2; Skin Sens. 1
sodium 3,5-bis(tetradecyloxycarbonyl)benzenesulfinate
AF-390
407-720-8
155160-86-4
Skin Sens. 1
sodium 3,5-dichloro-2-(5-cyano-2,6-bis(3-hydroxypropylamino)-4-methylpyridin-3-ylazo)benzenesulphonate
H: SÄUREGELB 2829
401-870-8
115035-41-1
Eye Dam. 1
sodium 3-(2-acetamido-4-(4-(2-hydroxybutoxy)phenylazo)phenylazo)benzenesulfonate
YELLOW E-JD 3442
410-150-2
147703-65-9
Skin Sens. 1
sodium 3-(2H-benzotriazol-2- yl)-5-sec-butyl-4-hydroxyben zenesulfonate
BENZTRIAZOL UV ABSORBER BUK 4499; BUK 4499; UV ABSORBER BUK 4499
403-080-9
92484-48-5
Eye Dam. 1
sodium 3-(methoxycarbonyl)-4-oxo-3,4,5,6-tetrahydro-2-pyridinolate
418-410-7
139122-78-4
Eye Irrit. 2
sodium 3-acetoacetylamino-4-methoxytolyl-6-sulfonate
ACETESSIG-KRESIDINSULFOSÄURES NATRIUMSALZ
411-680-7
133167-77-8
Skin Sens. 1
sodium 3-chloroacrylate
-
4312-97-4
Acute Tox. 4
sodium 3-nitrobenzenesulphonate
204-857-3
127-68-4
Eye Irrit. 2; Skin Sens. 1
sodium 4-(2,4,4-trimethylpentylcarbonyloxy)benzenesulfonate
ACTIZONE; PG 85; PHENOLESTER C; PHENOLESTER C/S
400-030-8
94612-91-6
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1
sodium 4-(4-chloro-6-(N-ethylanilino)-1,3,5-triazin-2-ylamino)-2-(1-(2-chlorophenyl)-5-hydroxy-3-methyl-1H-pyrazol-4-ylazo)benzenesulfonate
ACID YELLOW HT 2803; MONOAZO YELLOW HT 2803
407-800-2
136213-75-7
Skin Sens. 1
sodium 4-[4-(4-hydroxyphenylazo)phenylamino]-3-nitrobenzenesulfonate
ORANGE JOG 365
416-370-5
156738-27-1
Skin Sens. 1
sodium 4-chloro-1-hydroxybutane-1-sulfonate
BISULPHITE ADDUCT; GR59658A
406-190-5
54322-20-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
sodium 4-hydroxy-3-(N'-(2-(2-hydroxyethylenesulfonyl)ethylene)ureido)-5-nitrobenzenesulfonate
425-460-3
1379676-84-2
Skin Sens. 1
sodium 4-sulfophenyl-6-((1-oxononyl)amino)hexanoate
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
sodium 5-[2-chloro-4-(trifluoromethyl) phenoxy]-2-nitrobenzoate; acifluorfen-sodium
263-560-7
62476-59-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
sodium 5-n-butylbenzotriazole
COBRATEC 435
404-450-2
118685-34-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
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