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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
Tail gas (petroleum), catalytic cracked naphtha stabilization absorber; Petroleum gas [ complex combination of hydrocarbons obtained from the stabilization of catalytic cracked naphtha. It consists predomi nantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.]
A complex combination of hydrocarbons obtained from the stabilization of catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-803-0
68478-22-8
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
Tail gas (petroleum), catalytic cracked distillate and catalytic cracked naphtha fractionation absorber; Petroleum gas [he complex combination of hydrocarbons from the distillation of the products from catalytic cracked distillates and catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C4.]
The complex combination of hydrocarbons from the distillation of the products from catalytic cracked distillates and catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C4.
269-617-2
68307-98-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Tail gas (petroleum), catalytic cracked clarified oil and thermal cracked vacuum residue fractionation reflux drum; Petroleum gas [ complex combination of hydrocarbons obtained from fractionation of catalytic cracked clarified oil and thermal cracked vacuum residue. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.]
A complex combination of hydrocarbons obtained from fractionation of catalytic cracked clarified oil and thermal cracked vacuum residue. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-802-5
68478-21-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Taenia solium
-
-
P Parasites
Taenia saginata
-
-
P Parasites
symclosene; trichloroisocyanuric acid; trichloro-1,3,5-triazinetrion
201-782-8
87-90-1
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
sulphuryl difluoride
220-281-5
2699-79-8
Press. Gas; Acute Tox. 3; STOT RE 2
sulphuryl chloride
232-245-6
7791-25-5
Skin Corr. 1B; STOT SE 3
Sulphuric acid, cadmium salt (1:1), unspecified hydration rate
626-360-4
15244-35-6
yes
sulphuric acid ... %
231-639-5
7664-93-9
Skin Corr. 1A
sulphur tetrachloride
-
13451-08-6
Skin Corr. 1B
sulphur dioxide
231-195-2
7446-09-5
Press. Gas; Acute Tox. 3; Skin Corr. 1B
sulphur dichloride
234-129-0
10545-99-0
Skin Corr. 1B; STOT SE 3
sulphanilic acid; 4-aminobenzenesulphonic acid
204-482-5
121-57-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
sulphamidic acid; sulphamic acid; sulfamic acid
226-218-8
5329-14-6
Eye Irrit. 2; Skin Irrit. 2
Sulfurous acid, lead salt, dibasic
263-467-1
62229-08-7
yes
Sulfuric acid, cadmium salt (1:1), hydrate (3:8)
616-572-5
7790-84-3
yes
sulfur
231-722-6
7704-34-9
Skin Irrit. 2
sulfoxaflor (ISO); [methyl(oxo) {1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ6-sulfanylidene]cyanamide
807-366-8
946578-00-3
Acute Tox. 4
sulfotep (ISO); O, O,O, O-tetraethyl dithiopyrophosphate
222-995-2
3689-24-5
Acute Tox. 1; Acute Tox. 2
sulfallate (ISO); 2-chloroallyl N, N-dimethyldithiocarbamate
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
sulcotrione (ISO); 2-[2-chloro-4-(methylsulfonyl)benzoyl]cyclohexane-1,3-dione
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
succinic anhydride
203-570-0
108-30-5
Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
subtilisin
232-752-2
9014-01-1
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
styrene-4-sulfonyl chloride
STYRENE SULPHONYL CHLORIDE
404-770-2
2633-67-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
styrene oxide;(epoxyethyl)benzene; phenyloxirane
202-476-7
96-09-3
Carc. 1B; Acute Tox. 4; Eye Irrit. 2
styrene
202-851-5
100-42-5
Flam. Liq. 3; Repr. 2; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
strychnine
200-319-7
57-24-9
Acute Tox. 1; Acute Tox. 2
strychnidin-10-one, 2,3-dimethoxy-, mono[(R)-1-methylheptyl 1,2-benzenedicarboxylate]
269-439-5
68239-26-9
Acute Tox. 2
strychnidin-10-one, 2,3-dimethoxy-, compd.with (S) mono(1-methylheptyl)-1,2-benzenedicarboxylate (1:1)
269-710-8
68310-42-9
Acute Tox. 2
strophantin-K
234-239-9
11005-63-3
Acute Tox. 3; STOT RE 2
strontium chromate
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
yes
strontium 2-[(2-hydroxy-6-sulfonato-1-naphthyl)azo]naphthalene-1-sulfonate
427-930-3
250639-69-1
Skin Sens. 1
Strongyloides stercoralis
-
-
P Parasites
Strongyloides spp.
-
-
P Parasites
Streptococcus suis
-
-
B Bacteria and similar species
Streptococcus spp.
-
-
B Bacteria and similar species
Streptococcus pyogenes
-
-
B Bacteria and similar species
Streptococcus pneumoniae
-
-
B Bacteria and similar species
Streptobacillus moniliformis
-
-
B Bacteria and similar species
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
Staphylococcusaureus
-
-
B Bacteria and similar species
St Louis 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.
Sporothrix schenckii
-
-
F Fungi
spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
spirotetramat (ISO); (5s,8s)-3- (2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4,5]dec- 3-en-4-yl ethyl carbonate
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
spirodiclofen (ISO); 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
solvent naphtha (petroleum), medium aliph.; Straight run kerosine [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 C9 through C12 and boiling in the range of approximately 140°C to 220°C (284°F to 428°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 C9 through C12 and boiling in the range of approximately 140°C to 220°C (284°F to 428°F).
265-191-7
64742-88-7
STOT RE 1; 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
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