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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 23 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
mecarbam (ISO); N-ethoxycarbonyl-N-methylcarbamoylmethyl O, O-diethyl phosphorodithioate
219-993-9
2595-54-2
Acute Tox. 3
Measles 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.
MCPA-thioethyl (ISO); S-ethyl (4-chloro-2-methylphenoxy)ethanethioate; S-ethyl 4-chloro-o-tolyloxythioacetate
246-831-4
25319-90-8
Acute Tox. 4
MCPA (ISO); 4-chloro-o-tolyloxyacetic acid
202-360-6
94-74-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Mayaro 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.
Marburg 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.
Mansonella perstans
-
-
P Parasites
Mansonella ozzardi
-
-
P Parasites
mannitol hexanitrate; nitromannite;mannitol hexanitrate; nitromannite;[>40 % phlegmatiser]
239-924-6
15825-70-4
Unst. Expl.
mannitol hexanitrate; nitromannite;mannitol hexanitrate; nitromannite;[>40 % phlegmatiser]
239-924-6
15825-70-4
Expl. 1.1
manganese sulphate
232-089-9
7785-87-7
STOT RE 2
manganese dioxide
215-202-6
1313-13-9
Acute Tox. 4
maneb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric)
235-654-8
12427-38-2
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt
616-995-5
8018-01-7
Repr. 2; Skin Sens. 1
malononitrile
203-703-2
109-77-3
Acute Tox. 3
maleic anhydride
203-571-6
108-31-6
Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1A
maleic acid
203-742-5
110-16-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
malathion (ISO); 1,2-bis(ethoxycarbonyl)ethyl O, O-dimethyl phosphorodithioate [containing ≤ 0,03 % isomalathion]
204-497-7
121-75-5
Acute Tox. 4; Skin Sens. 1
malachite green oxalate
219-441-7
2437-29-8
Repr. 2; Acute Tox. 4; Eye Dam. 1
malachite green hydrochloride
209-322-8
569-64-2
Repr. 2; Acute Tox. 4; Eye Dam. 1
Main component: acetoacetic acid anilide/3-amino-1-hydroxybenzene (ATAN-MAP): trisodium {6-[(2 or 3 or 4)-amino-(4 or 5 or 6)-hydroxyphenylazo]-5'-(phenylsulfamoyl)-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato}-{6''-[1-(phenylcarbamoyl)ethylazo]-5'-(phenylsulfamoyl)-3-sulfonatonaphthalene-2''-azobenzene-1'',2'''-diolato}chromate (III); by-product 1: acetoacetic acid anilide/acetoacetic acid anilide (ATAN-ATAN): trisodium bis{6-[1-(phenylcarbamoyl)ethylazo]-5'''-(phenylsulfonyl)-3''-sulfonatonaphthalene-2-azobenzene-1,2'-diolato}chromate (III); by-product 2: 3-amino-1-hydroxybenzene/3-amino-1-hydroxybenzene (MAP-MAP): trisodium bis{6-[(2 or 3 or 4)-amino-(4 or 5 or 6)-hydroxyphenylazo]-5'-(phenylsulfamoyl)-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato}chromate (III)
BLACK JR 578
419-230-1
-
Skin Sens. 1
main component 6 (isomer): asym. 1:2 Cr(III)-complex of: A: 3-hydroxy-4-(2-hydroxy-naphthalene-1-ylazo)naphthalene-1-sulfonic acid, Na-salt and B: 1-[2-hydroxy-5-(4-methoxy-phenylazo)phenylazo]naphthalene-2-ol; main component 8 (isomer):; asym. 1:2 Cr-complex of: A:; 3-hydroxy-4-(2-hydroxy-naphthalene-1-ylazo)-naphthalene-1-sulfonic acid, Na-salt and B: 1-[2-hydroxy-5-(4-methoxy-phenylazo)-phenylazo]-naphthalene-2-ol
BLACK UL 1253
417-280-9
30785-74-1
Eye Dam. 1
main component 1 (isomer 1):; 2-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonapht-7-ylamino]-1,3,5-triazin-2-ylamino}-3-{6-fluoro-4-[3-(1,5-disulfonaphth-2-ylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt; main component 1 (isomer 2):; 2-{6-fluoro-4-[3-(2,5-disulfophenylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-3-{6-fluoro-4-[3(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt; main component 2: 2,3-bis-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt; main component 3: 2,3-bis-{6-fluoro-4-[3-(1,5-disulfonaphth-2-ylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt
422-610-1
-
Eye Dam. 1
magnesium powder (pyrophoric);magnesium, powder or turnings
231-104-6
7439-95-4
Flam. Sol. 1; Water-react. 2; Self-heat. 1
magnesium powder (pyrophoric);magnesium, powder or turnings
231-104-6
7439-95-4
Water-react. 1; Pyr. Sol. 1
magnesium phosphide; trimagnesium diphosphide
235-023-7
12057-74-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
magnesium hexafluorosilicate
241-022-2
16949-65-8
Acute Tox. 3
magnesium bis((R)-2-(2,4-dichlorophenoxy)propionate)
DUPLOSAN-DP-MAGNESIUM
413-360-2
164058-21-3
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
magnesium alkyls
-
-
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
Madurella mycetomatis
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-
F Fungi
Madurella grisea
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-
F Fungi
Machupo 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.
m-xylene
203-576-3
108-38-3
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
m-tolylidene diisocyanate; toluene-diisocyanate
247-722-4
26471-62-5
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
m-toluidine; 3-aminotoluene
203-583-1
108-44-1
Acute Tox. 3; STOT RE 2
m-phenylenediamine dihydrochloride
208-790-0
541-69-5
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
m-phenylenediamine
203-584-7
108-45-2
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
m-nitroaniline
202-729-1
99-09-2
Acute Tox. 3; STOT RE 2
m-mentha-1,3(8)-diene
PRODUCT 5899
404-150-1
17092-80-7
Skin Irrit. 2
m-cresol
203-577-9
108-39-4
Acute Tox. 3; Skin Corr. 1B
m-bis(2,3-epoxypropoxy)benzene; resorcinol diglycidyl ether
202-987-5
101-90-6
Carc. 1B; Muta. 2; Acute Tox. 3; Acute Tox. 4; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
Lymphocytic choriomeningitis virus (other strains)
-
-
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.
Lymphocytic (strains)
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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.
lufenuron (ISO); N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide
CGA 184699
410-690-9
103055-07-8
Skin Sens. 1
Lubricating oils; Baseoil — unspecified [ complex combination of hydrocarbons obtained from solvent extraction and dewaxing processes. It consists predominantly of saturated hydrocarbons having carbon numbers in the range C15 through C50.]
A complex combination of hydrocarbons obtained from solvent extraction and dewaxing processes. It consists predominantly of saturated hydrocarbons having carbon numbers in the range C15 through C50.
278-012-2
74869-22-0
Carc. 1B
Lubricating oils (petroleum), hydrocracked nonarom. solvent-deparaffined; Baseoil — unspecified
295-424-8
92045-43-7
Carc. 1B
Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated; Baseoil — unspecified [ complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of vacuum distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C25 and produces a finished oil with a viscosity in the order of 32cSt to 37cSt at 100 °C (212 °F).]
A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of vacuum distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C25 and produces a finished oil with a viscosity in the order of 32cSt to 37cSt at 100°C (212°F).
309-874-0
101316-69-2
Carc. 1B
Lubricating oils (petroleum), C24-50, solvent-extd., dewaxed, hydrogenated; Baseoil — unspecified [ complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C24 through C50 and produces a finished oil with a viscosity in the order of 16cSt to 75cSt at 40 °C (104 °F).]
A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C24 through C50 and produces a finished oil with a viscosity in the order of 16cSt to 75cSt at 40°C (104°F).
309-877-7
101316-72-7
Carc. 1B
Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based; Baseoil — unspecified [ complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of approximately 32cSt at 40 °C. It contains a relatively large proportion of saturated hydrocarbons.]
A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of approximately 32cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-738-4
72623-87-1
Carc. 1B
Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity; Baseoil — unspecified [ complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil, and; solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of approximately 112cSt at 40 °C. It contains a relatively large proportion of saturated hydrocarbons.]
A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil, and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of approximately 112cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-736-3
72623-85-9
Carc. 1B
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