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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 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
Naphtha (petroleum),heavy steam-cracked, hydrogenated; Low boiling point hydrogen treated naphtha
295-432-1
92045-51-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha (petroleum),light steam-cracked, debenzenized; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 80o C to 218o C (176°F to 424°F).]
A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 80°C to 218°C (176°F to 424°F).
271-266-5
68527-26-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha(petroleum), acid-treated; Low boilingpoint naphtha -unspecified [ complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90 o C to 230 o C (194 °F to 446 °F).]
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90°C to 230°C (194°F to 446°F).
265-115-2
64742-15-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Naphtha; Low boiling point naphtha [Refined, partly refined, or unrefined petroleum products produced by the distillation of natural gas. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C6 and boiling in the range of approximately 100o C to 200o C (212°F to 392°F).]
Refined, partly refined, or unrefined petroleum products produced by the distillation of natural gas. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C6 and boiling in the range of approximately 100°C to 200°C (212°F to 392°F).
232-443-2
8030-30-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Natural gas (petroleum), raw liq. mix; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons separated as a liquid from natural gas in a gas recycling plant by processes such as refrigeration or absorption. It consists mainly of saturated aliphatic hydrocarbons having carbon numbers in the range of C2 through C8.]
A complex combination of hydrocarbons separated as a liquid from natural gas in a gas recycling plant by processes such as refrigeration or absorption. It consists mainly of saturated aliphatic hydrocarbons having carbon numbers in the range of C2 through C8.
265-048-9
64741-48-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Natural gas condensates (petroleum); Low boiling point naphtha -unspecified [ complex combination of hydrocarbons separated as a liquid from natural gas in a surface separator by retrograde condensation. It consists mainly of hydrocarbons having carbon numbers predominantly in the range of C2 to C20. It is a liquid at atmospheric temperature and pressure.]
A complex combination of hydrocarbons separated as a liquid from natural gas in a surface separator by retrograde condensation. It consists mainly of hydrocarbons having carbon numbers predominantly in the range of C2 to C20. It is a liquid at atmospheric temperature and pressure.
265-047-3
64741-47-5
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
Petroleum products, hydrofiner-powerformer reformates; Low boiling point cat-reformed naphtha [he complex combination of hydrocarbons obtained in a hydrofiner-powerformer process and boiling in a range of approximately 27 °C to 210 °C (80°F to 410°F).]
The complex combination of hydrocarbons obtained in a hydrofiner-powerformer process and boiling in a range of approximately 27°C to 210°C (80°F to 410°F).
271-058-4
68514-79-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.; Low boiling point modified naphtha [ complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.]
A complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.
270-088-5
68410-71-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Raffinates (petroleum), reformer, Lurgi unit-sepd.; Low boiling point modified naphtha [he complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.]
The complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.
270-349-3
68425-35-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Residual oils (petroleum), deisobutanizer tower; Low boiling point naphtha -unspecified [ complex residuum from the atmospheric distillation of the butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.]
A complex residuum from the atmospheric distillation of the butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.
270-795-9
68478-16-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Residues (petroleum), butane splitter bottoms; Low boiling point naphtha -unspecified [ complex residuum from the distillation of butane stream. It consists of aliphatic hydro carbons having carbon numbers predominantly in the range of C4 through C6.]
A complex residuum from the distillation of butane stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.
270-791-7
68478-12-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Residues (petroleum), C6-8 catalytic reformer; Low boiling point cat-reformed naphtha [ complex residuum from the catalytic reforming of C6-8 feed. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C6.]
A complex residuum from the catalytic reforming of C6-8 feed. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C6.
270-794-3
68478-15-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
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
Solvent naphtha (petroleum), hydrotreated light naphthenic; Low boiling point hydrogen treated naphtha [ complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of cycloparaffinic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approxi mately 73o C to 85o C (163 °F to 185 °F).]
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of cycloparaffinic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 73°C to 85°C (163°F to 185°F).
295-529-9
92062-15-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Solvent naphtha (petroleum), light aliph.; Low boiling point naphtha [ complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 35o C to 160o C (95°F to 320°F).]
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 35°C to 160°C (95°F to 320°F).
265-192-2
64742-89-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Solvent naphtha (petroleum), light arom., hydrotreated; Low boiling point hydrogen treated naphtha [ complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approxi mately 135 °C to 210 °C (275°F to 410°F).]
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135°C to 210°C(275°F to 410°F).
270-988-8
68512-78-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Solvent naphtha (petroleum), light arom.; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135 °C to 210 °C (275°F to 410°F).]
A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135°C to 210°C (275°F to 410°F).
265-199-0
64742-95-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
potassium chromate
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
1,2-dibromo-3-chloropropane
202-479-3
96-12-8
Carc. 1B; Muta. 1B; Repr. 1A; Acute Tox. 3; STOT RE 2
N-[6,9-dihydro-9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6-oxo-1H-purin-2-yl]acetamide
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
cadmium chloride
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cadmium chloride (CdCl2), hydrate (2:5) EC / List no: 640-998-0 | CAS no: 7790-78-5
233-296-7
10108-64-2
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
cadmium fluoride
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
Cadmium sulphate;cadmium sulphate
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Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
233-331-6
10124-36-4;31119-53-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
sodium chromate
231-889-5
7775-11-3
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
benzo[a]pyrene; benzo[def]chrysene
200-028-5
50-32-8
Carc. 1B; Muta. 1B; Repr. 1B; Skin Sens. 1
yes
4,4'-oxydianiline and its salts; p-aminophenyl ether
-
-
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
4,4'-oxydianiline and its salts; p-aminophenyl ether
202-977-0
101-80-4
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
acrylamide; prop-2-enamide
201-173-7
79-06-1
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
yes
2-nitrotoluene
201-853-3
88-72-2
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 4
N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA]
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
naphtha (petroleum), hydrodesulphurized heavy; Low boiling point hydrogen treated naphtha [A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90o C to 230o C (194°F to 446 °F).]
A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90°C to 230°C (194°F to 446°F).
265-185-4
64742-82-1
Carc. 1B; Muta. 1B; STOT RE 1; Asp. Tox. 1
stoddard solvent; Low boiling point naphtha —; unspecified [ colourless, refined petroleum distillate that is free from rancid or objectionable odours and that boils in a range of approximately 148,8 °C to 204,4 o C (300°F to 400°F).]
A colorless, refined petroleum distillate that is free from rancid or objectionable odors and that boils in a range of approximately 148.8°C to 204.4°C (300°F to 400°F).
232-489-3
8052-41-3
Carc. 1B; Muta. 1B; STOT RE 1; Asp. Tox. 1
(2-chloroethyl)(3-hydroxypropyl)ammonium chloride
CLETOPROPAMINHYDROCHLORID
429-740-6
40722-80-3
Carc. 1B; Muta. 1B; STOT RE 2; Skin Sens. 1
methyl acrylamidoglycolate (containing ≥ 0,1 % acrylamide)
MAGME(R) 200 MONOMER
403-230-3
77402-05-2
Carc. 1B; Muta. 1B; Skin Corr. 1B; Skin Sens. 1
reaction mass of: dimethyl (2-(hydroxymethylcarbamoyl)ethyl)phosphonate; diethyl (2-(hydroxymethylcarbamoyl)ethyl)phosphonate; methyl ethyl (2-(hydroxymethylcarbamoyl)ethyl)phosphonate
435-960-3
-
Carc. 1B; Muta. 1B; Skin Sens. 1
benzo[rst]pentaphene
205-877-5
189-55-9
Carc. 1B; Muta. 2
biphenyl-3,3', 4,4'-tetrayltetraamine; diaminobenzidine
202-110-6
91-95-2
Carc. 1B; Muta. 2
chrysene
205-923-4
218-01-9
Carc. 1B; Muta. 2
yes
dibenzo[b,def]chrysene; dibenzo[a,h]pyrene
205-878-0
189-64-0
Carc. 1B; Muta. 2
dibenzo[def,p]chrysene; dibenzo[a,l]pyrene
205-886-4
191-30-0
Carc. 1B; Muta. 2
dimethyl sulphate
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
2-methoxyaniline; o-anisidine
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
4-chloro-o-toluidine
202-441-6
95-69-2
Carc. 1B; Muta. 2; Acute Tox. 3
4-chloro-o-toluidine hydrochloride
221-627-8
3165-93-3
Carc. 1B; Muta. 2; Acute Tox. 3
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
1,2-dihydroxybenzene; pyrocatechol
204-427-5
120-80-9
Carc. 1B; Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
phenylhydrazine
202-873-5
100-63-0
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
phenylhydrazine hydrochloride
248-259-0
27140-08-5
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
phenylhydrazinium chloride
200-444-7
59-88-1
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
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