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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
monocrotophos (ISO); dimethyl-1-methyl-2-(methylcarbamoyl)vinyl phosphate
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
1-ethyl-1-methylpyrrolidinium bromide
MEP
418-200-5
69227-51-6
Muta. 2
2,2-dibromo-2-nitroethanol
PERMACHEM N21
412-380-9
69094-18-4
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Skin Sens. 1
2,3-dichloro-5-trifluoromethyl- pyridine
DCTFMP
410-340-5
69045-84-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-fluoro-5-trifluoromethylpyridine
G.1417
400-290-2
69045-82-5
Flam. Liq. 3; Skin Sens. 1
3-(2'-phenoxyethoxy)propylamine
427-870-8
6903-18-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
nickel matte
Product of blowing smelted nickel ore in a converter to lower the iron content.
273-749-6
69012-50-6
Carc. 1A; STOT RE 1; Skin Sens. 1
[Phthalato(2-)]dioxotrilead
273-688-5
69011-06-9
yes
salicylic acid
200-712-3
69-72-7
Repr. 2; Acute Tox. 4; Eye Dam. 1
Tar, coal, high-temp., high-solids; Coal Tar Solids Residue [The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700 °C (1292 °F)) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal-type materials.]
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal- and coke-type materials.
273-615-7
68990-61-4
Carc. 1B
Gases (petroleum), crude distn. and catalytic cracking; Refinery gas [ complex combination produced by crude distillation and catalytic cracking processes. It consists of hydrogen, hydrogen sulfide, nitrogen, carbon monoxide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.]
A complex combination produced by crude distillation and catalytic cracking processes. It consists of hydrogen, hydrogen sulfide, nitrogen, carbon monoxide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
273-563-5
68989-88-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
2,4,6-tri-n-propyl-2,4,6-trioxo-1,3,5,2,4,6-trioxatriphosphorinane
T3P
422-210-5
68957-94-8
Skin Corr. 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
Naphtha (petroleum), catalytic reformed; Low boiling point cat-reformed naphtha [ complex combination of hydrocarbons produced by the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30 °C to 220 °C (90°F to 430°F). It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 vol. % or more benzene.]
A complex combination of hydrocarbons produced by the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30°C to 220°C (90°F to 430°F). It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 vol. % or more benzene.
273-271-8
68955-35-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Gases (petroleum), straight-run naphtha catalytic reformer stabilizer overhead; Petroleum gas [ complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and the frac tionation of the total effluent.; It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.]
A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and the fractionation of the total effluent. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.
273-270-2
68955-34-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), sponge absorber off, fluidized catalytic cracker and gas oil desulfurizer overhead fractionation; Refinery gas [ complex combination obtained by the fractionation of products from the fluidized catalytic cracker and gas oil desulfurizer. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.]
A complex combination obtained by the fractionation of products from the fluidized catalytic cracker and gas oil desulfurizer. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
273-269-7
68955-33-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Distillates (petroleum), light thermal cracked, debutanized arom.; Low boiling point thermally cracked naphtha [ complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists predominantly of aromatic hydrocarbons, primarily benzene.]
A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists predominantly of aromatic hydrocarbons, primarily benzene.
273-266-0
68955-29-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Gases (petroleum, light steam-cracked, butadiene conc.; Petroleum gas [ complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists of hydrocarbons having a carbon number predominantly of C4.]
A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists of hydrocarbons having a carbon number predominantly of C4.
273-265-5
68955-28-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Distillates (petroleum), petroleum residues vacuum; Heavy Fuel oil [A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from the atmospheric distillation of crude oil.]
A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from the atmospheric distillation of crude oil.
273-263-4
68955-27-1
Carc. 1B
Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabilizer, petroleum coking; Petroleum gas [ complex combination of hydrocarbons obtained from the fractionation stabilization of thermal cracked hydrocarbons from petroleum coking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.]
A complex combination of hydrocarbons obtained from the fractionation stabilization of thermal cracked hydrocarbons from petroleum coking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
273-176-1
68952-82-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber; petroleum gas [ complex combination of hydrocarbons obtained from the separation of thermal-cracked distillates, naphtha and gas oil. It consists pedrominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.]
A complex combination of hydrocarbons obtained from the separation of thermal-cracked distillates, naphtha and gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
273-175-6
68952-81-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Tail gas (petroleum), straight-run naphtha hydrodesulfurizer; Refinery gas [ complex combination obtained from the hydrodesulfurization of straight-run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.]
A complex combination obtained from the hydrodesulfurization of straight-run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
273-174-0
68952-80-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Tail gas (petroleum), catalytic hydrodesulfurized naphtha separator; Refinery gas [ complex combination of hydrocarbons obtained from the hydrodesulfurization of naphtha. It consists of hydrogen, methane, ethane, and propane.]
A complex combination of hydrocarbons obtained from the hydrodesulfurization of naphtha. It consists of hydrogen, methane, ethane, and propane.
273-173-5
68952-79-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Tail gas (petroleum), catalytic cracked distillate and naphtha stabilizer; Petroleum gas [ complex combination of hydrocarbons obtained by the fractionation of catalytic cracked naphtha and distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.]
A complex combination of hydrocarbons obtained by the fractionation of catalytic cracked naphtha and distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
273-170-9
68952-77-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), catalytic cracked naphtha debutanizer; Petroleum gas [ complex combination of hydrocarbons obtained from fractionation of catalytic cracked naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.]
A complex combination of hydrocarbons obtained from fractionation of catalytic cracked naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
273-169-3
68952-76-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Extract oils (coal), tar base, collidine fraction; Distillate Bases [The extract produced by the acidic extraction of bases from crude coal tar aromatic oils, neutralization, and distillation of the bases. Composed primarily of collidines, aniline, toluidines, lutidines, xylidines.]
The extract produced by the acidic extraction of bases from crude coal tar aromatic oils, neutralization, and distillation of the bases. Composed primarily of collidines, aniline, toluidines, lutidines, xylidines.
273-077-3
68937-63-3
Carc. 1B; Muta. 1B
Distillates (petroleum), naphtha unifiner stripper; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons produced by stripping the products from the naphtha unifiner. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.]
A complex combination of hydrocarbons produced by stripping the products from the naphtha unifiner. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.
272-932-8
68921-09-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), light straight-run gasoline frac tionation stabilizer overheads; Low boiling point naphtha [ complex combination of hydrocarbons obtained by the fractionation of light straight-run gasoline. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in he range of C3 through C6.]
A complex combination of hydrocarbons obtained by the fractionation of light straight-run gasoline. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C6.
272-931-2
68921-08-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Natural gas condensates; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons separated and/or condensed from natural gas during transportation and collected at the wellhead and/or from the production, gathering, transmission, and distribution pipelines in deeps, scrubbers, etc. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C2 through C8.]
A complex combination of hydrocarbons separated and/or condensed from natural gas during transportation and collected at the wellhead and/or from the production, gathering, transmission, and distribution pipelines in deeps, scrubbers, etc. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C2 through C8.
272-896-3
68919-39-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum), full-range reformed; Low boiling point cat-reformed naphtha [ complex combination of hydrocarbons produced by the distillation of the products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 35°C to 230 °C (95°F to 446°F).]
A complex combination of hydrocarbons produced by the distillation of the products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 35°C to 230°C (95°F to 446°F).
272-895-8
68919-37-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Gases(petroleum), fluidized catalytic cracker splitter overheads; Petroleum gas [ complex combination of hydrocarbons produced by the fractionation of the charge to the C3-C4 splitter. It consists predominantly of C3 hydrocarbons.]
A complex combination of hydrocarbons produced by the fractionation of the charge to the C3-C4 splitter. It consists predominantly of C3 hydrocarbons.
272-893-7
68919-20-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), unifiner stripper off; Refinery gas [ combination of hydrogen and methane obtained by fractionation of the products from the unifiner unit.]
A combination of hydrogen and methane obtained by fractionation of the products from the unifiner unit.
272-885-3
68919-12-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), tar stripper off; Refinery gas [ complex combination obtained by the fractionation of reduced crude oil. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.]
A complex combination obtained by the fractionation of reduced crude oil. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
272-884-8
68919-11-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), straight-run stabilizer off; Petroleum gas [ complex combination of hydrocarbons obtained from the fractionation of the liquid from the first tower used in the distillation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.]
A complex combination of hydrocarbons obtained from the fractionation of the liquid from the first tower used in the distillation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
272-883-2
68919-10-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), straight-run naphtha catalytic reforming off; Petroleum gas [ complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and fractionation of the total effluent. It consists of methane, ethane, and propane.]
A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and fractionation of the total effluent. It consists of methane, ethane, and propane.
272-882-7
68919-09-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), preflash tower off, crude distn.; Refinery gas [ complex combination produced from the first tower used in the distillation of crude oil. It consists of nitrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.]
A complex combination produced from the first tower used in the distillation of crude oil. It consists of nitrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-881-1
68919-08-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), platformer stabilizer off, light ends fractionation; Refinery gas [ complex combination obtained by the fractionation of the light ends of the platinum reactors of the platformer unit. It consists of hydrogen, methane, ethane and propane.]
A complex combination obtained by the fractionation of the light ends of the platinum reactors of the platformer unit. It consists of hydrogen, methane, ethane, and propane.
272-880-6
68919-07-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), naphtha unifiner desulfurization stripper off; Petroleum gas [ complex combination of hydrocarbons produced by a naphtha unifiner desulfurization process and stripped from the naphtha product. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.]
A complex combination of hydrocarbons produced by a naphtha unifiner desulfurization process and stripped from the naphtha product. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
272-879-0
68919-06-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), light straight run gasoline fractionation stabilizer off; Petroleum gas [ complex combination of hydrocarbons obtained by the fractionation of light straight-run gasoline. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.]
A complex combination of hydrocarbons obtained by the fractionation of light straight-run gasoline. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-878-5
68919-05-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), heavy distillate hydrotreater desulfurization stripper off; Refinery gas [ complex combination stripped from the liquid product of the heavy distillate hydrotreater desulfurization process. It consists of hydrogen, hydrogen sulfide, and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.]
A complex combination stripped from the liquid product of the heavy distillate hydrotreater desulfurization process. It consists of hydrogen, hydrogen sulfide, and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-876-4
68919-04-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), fluidized catalytic cracker scrubbing secondary absorber off; Refinery gas [ complex combination produced by scrubbing the overhead gas from the fluidized catalytic cracker. It consists of hydrogen, nitrogen, methane, ethane and propane.]
A complex combination produced by scrubbing the overhead gas from the fluidized catalytic cracker. It consists of hydrogen, nitrogen, methane, ethane and propane.
272-875-9
68919-03-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), fluidized catalytic cracker fractionation off; Refinery gas [ complex combination produced by the fractionation of the overhead product of the fluidized catalytic cracking process. It consists of hydrogen, hydrogen sulfide, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.]
A complex combination produced by the fractionation of the overhead product of the fluidized catalytic cracking process. It consists of hydrogen, hydrogen sulfide, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-874-3
68919-02-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), distillate unifiner desulfurization stripper off; Refinery gas [ complex combination stripped from the liquid product of the unifiner desulfurization process. It consists of hydrogen sulfide, methane, ethane, and propane.]
A complex combination stripped from the liquid product of the unifiner desulfurization process. It consists of hydrogen sulfide, methane, ethane, and propane.
272-873-8
68919-01-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), dehexanizer off; Petroleum gas [ complex combination of hydrocarbons obtained by the Fractionation of combined naphtha streams. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.]
A complex combination of hydrocarbons obtained by the fractionation of combined naphtha streams. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-872-2
68919-00-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), crude oil fractionation off; Petroleum gas [ complex combination of hydrocarbons produced by the fractionation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.]
A complex combination of hydrocarbons produced by the fractionation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-871-7
68918-99-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), hydrotreated sour kerosine flash drum; Refinery gas [ complex combination obtained from the flash drum of the unit treating sour kerosine with hydrogen in the presence of a catalyst. It consists primarily of hydrogen and methane with various small amounts of nitrogen, carbon monoxide, and hydrocarbons having carbon numbers predominantly in the range of C2 through C5.]
A complex combination obtained from the flash drum of the unit treating sour kerosine with hydrogen in the presence of a catalyst. It consists primarily of hydrogen and methane with various small amounts of nitrogen, carbon monoxide, and hydrocarbons having carbon numbers predominantly in the range of C2 through C5.
272-776-0
68911-59-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Gases (petroleum), hydrotreated sour kerosine depentanizer stabilizer off; Refinery gas [he complex combination obtained from the depentanizer stabilization of hydrotreated kerosine. It consists primarily of hydrogen, methane, ethane, and propane with various small amounts of nitrogen, hydrogen sulfide, carbon monoxide and hydrocarbons having carbon numbers predominantly in the range of C4 through C5.]
The complex combination obtained from the depentanizer stabilization of hydrotreated kerosine. It consists primarily of hydrogen, methane, ethane, and propane with various small amounts of nitrogen, hydrogen sulfide, carbon monoxide and hydrocarbons having carbon numbers predominantly in the range of C4 through C5.
272-775-5
68911-58-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
1,1-dimethylpropyl 3,5,5-trimethylperoxyhexanoate
LUPEROX 570
431-610-9
68860-54-8
Org. Perox. D; Skin Sens. 1
Tar acids, cresylic, sodium salts, caustic solns.; Alkaline Extract
272-361-4
68815-21-4
Carc. 1B; Muta. 1B
Gases (petroleum), platformer products separator off; Refinery gas [ complex combination obtained from the chemical reforming of naphthenes to aromatics. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.]
A complex combination obtained from the chemical reforming of naphthenes to aromatics. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.
272-343-6
68814-90-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
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