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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 24 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
S-metolachlor; reaction mass of (S)-2-chloro-N-(2-ethyl-6-methyl-phenyl)-N-(2-methoxy-1-methyl-ethyl)-acetamide (80-100 %)
618-004-1
87392-12-9
Skin Sens. 1
S-ethyl N-(dimethylaminopropyl)thiocarbamatehydrochloride; prothiocarb hydrochloride
243-193-9
19622-19-6
Acute Tox. 4
S-bioallethrin; [3]; (S)-3-allyl-2-methyl-4-oxocyclopent-2-enyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
249-013-5
28434-00-6
Acute Tox. 4
S-[2-(isopropylsulphinyl)ethyl] O,O-dimethyl phosphorothioate
-
2635-50-9
Acute Tox. 3
S-[2-(ethylsulphinyl)ethyl] O,O-dimethyl phosphorodithioate
620-370-2
2703-37-9
Acute Tox. 2; Acute Tox. 1
S-(chlorophenylthiomethyl) O,O-dimethylphosphorodithioate; methylcarbophenothione
-
953-17-3
Acute Tox. 3
S-(3-trimethoxysilyl)propyl 19-isocyanato-11-(6-isocyanatohexyl)-10,12-dioxo-2,9,11,13-tetraazanonadecanethioate
ALKYL ISOCYANATE SILANE SCD 617
402-290-8
85702-90-5
Flam. Liq. 3; Resp. Sens. 1; Skin Sens. 1
S-(3-(triethoxysilyl)propyl)octanethioate
436-690-9
220727-26-4
Skin Sens. 1
R—2,3-epoxy-1-propanol
R-GLYCIDOL
404-660-4
57044-25-4
Self-react. C; Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
Russian spring-summer encephalitis
-
-
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.
Rubivirus
-
-
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.
Ross River 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.
rosin; colophony
277-299-1
73138-82-6
Skin Sens. 1
rosin; colophony
A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
232-484-6
8052-10-6
Skin Sens. 1
rosin; colophony
A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.
232-475-7
8050-09-7
Skin Sens. 1
Rocio
-
-
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.
Rift Valley 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.
Rickettsia typhi
-
-
B Bacteria and similar species
Rickettsia tsutsugamushi
-
-
B Bacteria and similar species
Rickettsia spp.
-
-
B Bacteria and similar species
Rickettsia rickettsii
-
-
B Bacteria and similar species
Rickettsia prowazekii
-
-
B Bacteria and similar species
Rickettsia montana
-
-
B Bacteria and similar species
Rickettsia conorii
-
-
B Bacteria and similar species
Rickettsia canada
-
-
B Bacteria and similar species
Rickettsia akari
-
-
B Bacteria and similar species
Rhodococcusequi
-
-
B Bacteria and similar species
Rhinoviruses
-
-
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.
Reuviruses
-
-
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.
Respiratory syncytial 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.
resorcinol; 1,3-benzenediol
203-585-2
108-46-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
resmethrin (ISO);5-benzyl-3-furylmethyl (±)-cis-trans-chrysanthemate
233-940-7
10453-86-8
Acute Tox. 4
Residues,(petroleum), heavy coker gas oil and vacuum gas oil; Heavy Fuel oil [A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and vacuum gas oil. It predomi nantly consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230 °C (446 °F).]
A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and vacuum gas oil. It predominantly consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
270-796-4
68478-17-1
Carc. 1B
Residues, steam cracked, thermally treated; Heavy Fuel oil [A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180°C (356°F).]
A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180°C (356°F).
308-733-0
98219-64-8
Carc. 1B
Residues(petroleum), light vacuum; Heavy Fuel oil [A complex residuum from the vacuum distillation of the residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230 °C (446 °F).]
A complex residuum from the vacuum distillation of the residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
270-984-6
68512-62-9
Carc. 1B
Residues(petroleum), coker scrubber, Condensed-ring-arom.-contg.; Heavy Fuel oil [A very complex combination of hydrocarbons produced as the residual fraction from the distillation of vaccum residuum and the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C (662 °F). This stream is likely to contain 5 wt.% or more of 4-to 6-membered condensed rind aromatic hydrocarbons.]
A very complex combination of hydrocarbons produced as the residual fraction from the distillation of vacuum residuum and the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
272-187-9
68783-13-1
Carc. 1B
Residues (petroleum), vacuum, light; Heavy Fuel oil [A complex residuum from the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C24 and boiling above approximately 390 °C (734 °F).]
A complex residuum from the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C24 and boiling above approximately 390°C (734°F).
292-658-2
90669-76-4
Carc. 1B
Residues (petroleum), topping plant, low-sulfur; Heavy Fuel oil [A low-sulfur complex combination of hydrocarbons produced as the residual fraction from the topping plant distillation of crude oil. It is the residuum after the straight-run gasoline cut, kerosene cut and gas oil cut have been removed.]
A low-sulfur complex combination of hydrocarbons produced as the residual fraction from the topping plant distillation of crude oil. It is the residuum after the straight-run gasoline cut, kerosene cut and gas oil cut have been removed.
271-763-7
68607-30-7
Carc. 1B
Residues (petroleum), thermal cracked; Heavy Fuel oil [A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662 °F). This stream is likely to contain 5 wt. % or more of 4-to 6-membered condensed ring aromatic hydrocarbons.]
A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-081-9
64741-80-6
Carc. 1B
Residues (petroleum), steam-cracked; Heavy Fuel oil [A complex combination of hydrocarbons obtained as the residual fraction from the distillation of the products of a steam cracking process (including steam cracking to produce ethylene). It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C14 and boiling above approximately 260 °C (500 °F). This stream is likely to contain 5 wt. % or more of 4-to 6-memberedcondensed ring aromatic hydrocarbons.]
A complex combination of hydrocarbons obtained as the residual fraction from the distillation of the products of a steam cracking process (including steam cracking to produce ethylene). It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C14 and boiling above approximately 260°C (500°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-193-8
64742-90-1
Carc. 1B
Residues (petroleum), steam-cracked, resinous; Heavy Fuel oil [A complex residuum from the distillation of steam-cracked petroleum residues.]
A complex residuum from the distillation of steam-cracked petroleum residues.
273-272-3
68955-36-2
Carc. 1B
Residues (petroleum), steam-cracked, distillates; Heavy Fuel oil [A complex combination of hydrocarbons obtained during the production of refined petroleum tar by the distillation of steam cracked tar. It consists predominantly of aromatic and other hydrocarbons and organic sulfur compounds.]
A complex combination of hydrocarbons obtained during the production of refined petroleum tar by the distillation of steam cracked tar. It consists predominantly of aromatic and other hydrocarbons and organic sulfur compounds.
292-657-7
90669-75-3
Carc. 1B
Residues (petroleum), steam-cracked naphtha distn.; Cracked gasoil [ complex combination of hydrocarbons obtained as a column bottom from the separation of effluents from steam cracking naphtha at a high temperature. It boils in the range of approximately 147 °C to 300 °C (297 °F to 572 °F) and produces a finished oil having a viscosity of 18cSt at 50 °C.]
A complex combination of hydrocarbons obtained as a column bottom from the separation of effluents from steam cracking naphtha at a high temperature. It boils in the range of approximately 147°C to 300°C (297°F to 572°F) and produces a finished oil having a viscosity of 18cSt at 50°C.
295-517-3
92062-04-9
Carc. 1B
Residues (petroleum), steam-cracked light; Heavy Fuel oil [A complex residuum from the distillation of the products from a steam-cracking process. It consists predominantly of aromatic and unsaturated hydrocarbons having carbon numbers greater than C7 and boiling in the range of approximately 101°C to 555 °C (214 °F to 1030°F).]
A complex residuum from the distillation of the products from a steam-cracking process. It consists predominantly of aromatic and unsaturated hydrocarbons having carbon numbers greater than C7 and boiling in the range of approximately 101°C to 555°C (214°F to 1030°F).
271-013-9
68513-69-9
Carc. 1B
Residues (petroleum), steam-cracked light, arom.; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained by the distillation of the products of steamcracking or similar processes after taking off the very light products resulting in a residue starting with hydrocarbons having carbon numbers greater than C5. It consists predominantly of aromatic hydrocarbons having carbon numbers greater than C5 and boiling above approximately 40o C (104°F).]
A complex combination of hydrocarbons obtained by the distillation of the products of steam cracking or similar processes after taking off the very light products resulting in a residue starting with hydrocarbons having carbon numbers greater than C5. It consists predominantly of aromatic hydrocarbons having carbon numbers greater than C5 and boiling above approximately 40°C (104°F).
310-057-6
102110-55-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Residues (petroleum), steam-cracked heat-soaked naphtha; Cracked gasoil [ complex combination of hydrocarbons obtained as residue from the distillation of steam cracked heat soaked naphtha and boiling in the range of approximately 150 °C to 350 °C (302 °F to 662 °F).]
A complex combination of hydrocarbons obtained as residue from the distillation of steam cracked heat soaked naphtha and boiling in the range of approximately 150°C to 350°C (302°F to 662°F).
297-905-8
93763-85-0
Carc. 1B
Residues (petroleum), hydrogenated steam-cracked naphtha; Cracked gasoil [ complex combination of hydrocarbons obtained as a residual fraction from the distillation of hydrotreated steam-cracked naphtha. It consists predominantly of hydrocarbons boiling in the range of approximately 200°C to 350°C (32 °F to 662 °F).]
A complex combination of hydrocarbons obtained as a residual fraction from the distillation of hydrotreated steam-cracked naphtha. It consists predominantly of hydrocarbons boiling in the range of approximately 200°C to 350°C (32°F to 662°F).
295-514-7
92062-00-5
Carc. 1B
Residues (petroleum), hydrodesulfurized atmospheric tower; Heavy Fuel oil [A complex combination of hydrocarbons obtained by treating an atmospheric tower residuum with hydrogen in the presence of a catalyst under conditions primarily to remove organic sulfur compounds. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C (662 °F). This stream is likely to contain 5 wt. % or more of 4-to 6-membered condensed ring aromatic hydrocarbons.]
A complex combination of hydrocarbons obtained by treating an atmospheric tower residuum with hydrogen in the presence of a catalyst under conditions primarily to remove organic sulfur compounds. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-181-2
64742-78-5
Carc. 1B
Residues (petroleum), hydrocracked; Heavy Fuel oil [A complex combination of hydrocarbons produced as the residual fraction from distillation of the products of a hydrocracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approxi mately 350°C (662 °F).]
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products of a hydrocracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F).
265-076-1
64741-75-9
Carc. 1B
Residues (petroleum), heavy coker and light vacuum; Heavy Fuel oil [A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and light vacuum gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230 °C (446 °F).]
A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and light vacuum gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C(446°F).
270-983-0
68512-61-8
Carc. 1B
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