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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 01 May 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
reaction mass of: 2,2'-bis(tert-pentylperoxy)-p-diisopropylbenzene; 2,2'-bis(tert-pentylperoxy)-m-diisopropylbenzene
PEROXIMON 180
412-140-3
32144-25-5
Org. Perox. D
dilauroyl peroxide
203-326-3
105-74-8
Org. Perox. D
3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate
LUPEROX 610-E-35; LUPEROX 610-E-50; LUPEROX 610-EN-50; LUPEROX 610-M-50; LUPERSOL 610; LUPERSOL 610-M-50
413-910-1
1467668-33-2
Org. Perox. C; Flam. Liq. 3; Skin Irrit. 2
6-(nonylamino)-6-oxo-peroxyhexanoic acid
ELFADOX EN 3001
406-680-9
104788-63-8
Org. Perox. C; Eye Dam. 1; Skin Sens. 1
reaction mass of: 1,2-dimethylpropylidene dihydroperoxide; dimethyl 1,2-benzenedicarboxylate
442-480-8
-
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
cyclohexylidene hydroperoxide [> 91 % solution];cyclohexylidene hydroperoxide [≤ 91 % solution]
220-279-4
2699-11-8
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
cyclohexanone, peroxide [> 91 % solution];cyclohexanone, peroxide [≤ 91 % solution]
235-527-7
12262-58-7
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
1-hydroperoxycyclohexyl 1-hydroxycyclohexyl peroxide [> 91 % solution];1-hydroperoxycyclohexyl 1-hydroxycyclohexyl peroxide [≤ 91 % solution]
201-091-1
78-18-2
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
1,1'-dioxybiscyclohexan-1-ol [> 91 % solution];1,1'-dioxybiscyclohexan-1-ol [≤ 91 % solution]
219-306-2
2407-94-5
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
reaction mass of: 1-methyl-1-(3-(1-methylethyl)phenyl)ethyl-1-methyl-1-phenylethylperoxide,; 63 % by weight; 1-methyl-1-(4-(1-methylethyl)phenyl)ethyl-1-methyl-1-phenylethylperoxide, 31 % by weight
PEROXIMON S 168 TECHNICALLY PURE
410-840-3
71566-50-2
Org. Perox. C
O, O-tert-butyl O-docosyl monoperoxyoxalate
KENODOX
404-300-6
116753-76-5
Org. Perox. C
dibenzoyl peroxide; benzoyl peroxide
202-327-6
94-36-0
Org. Perox. B; Eye Irrit. 2; Skin Sens. 1
methylethylketone peroxide trimer
429-320-2
24748-23-0
Org. Perox. B; Asp. Tox. 1; Skin Irrit. 2; Skin Sens. 1
bis(4-methylbenzoyl)peroxide
INTEROX-PMBP-70W; INTEROX-PMPB-70W
407-950-9
895-85-2
Org. Perox. B
cyclohexylidene hydroperoxide [> 91 % solution];cyclohexylidene hydroperoxide [≤ 91 % solution]
220-279-4
2699-11-8
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
cyclohexanone, peroxide [> 91 % solution];cyclohexanone, peroxide [≤ 91 % solution]
235-527-7
12262-58-7
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
1-hydroperoxycyclohexyl 1-hydroxycyclohexyl peroxide [> 91 % solution];1-hydroperoxycyclohexyl 1-hydroxycyclohexyl peroxide [≤ 91 % solution]
201-091-1
78-18-2
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
1,1'-dioxybiscyclohexan-1-ol [> 91 % solution];1,1'-dioxybiscyclohexan-1-ol [≤ 91 % solution]
219-306-2
2407-94-5
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
reaction mass of: 4-allyl-2,6-bis(2,3-epoxypropyl)phenol; 4-allyl-6-[3-[6-[3-[6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol; 4-allyl-6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol; 4-allyl-6-[3-[6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
-
Muta. 2; Skin Sens. 1
N,N,N',N'-tetraglycidyl-4,4'-diamino-3,3'-diethyldiphenylmethane
PFMT 1848
410-060-3
130728-76-6
Muta. 2; Skin Sens. 1
chloro-1-ethylcyclohexyl carbonate
444-950-8
99464-83-2
Muta. 2; Skin Sens. 1
(6R-trans)-1-((7-ammonio-2- carboxylato-8-oxo-5-thia-1- azabicyclo-[4.2.0]oct-2-en-3- yl)methyl)pyridinium iodide
423-260-0
100988-63-4
Muta. 2; Skin Sens. 1
[(tolyloxy)methyl]oxirane; cresyl glycidyl ether
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
[(p-tolyloxy)methyl]oxirane
218-574-8
2186-24-5
Muta. 2; Skin Irrit. 2; Skin Sens. 1
[(m-tolyloxy)methyl]oxirane
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
2,3-epoxypropyl o-tolyl ether
218-645-3
2210-79-9
Muta. 2; Skin Irrit. 2; Skin Sens. 1
divanadium pentaoxide; vanadium pentoxide
215-239-8
1314-62-1
Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3
mercury dichloride; mercuric chloride
231-299-8
7487-94-7
Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1; Skin Corr. 1B
dibutyltin dilaurate; dibutyl[bis(dodecanoyloxy)] stannane
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
dibutyltin dichloride; (DBTC)
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
cycloheximide (ISO);4-{(2R)-2-[(1S,3S,5S)-3,5- dimethyl-2-oxocyclohexyl]-2- hydroxyethyl}piperidine-2,6- dione
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
trimethylopropane tri(3-aziridinylpropanoate); (TAZ)
257-765-0
52234-82-9
Muta. 2; Eye Dam. 1; Skin Sens. 1
1,3-bis(vinylsulfonylacetamido)propane
H-604
428-350-3
93629-90-4
Muta. 2; Eye Dam. 1; Skin Sens. 1
thiophanate-methyl (ISO); 1,2-di-(3-methoxycarbonyl-2-thioureido)benzene
245-740-7
23564-05-8
Muta. 2; Acute Tox. 4; Skin Sens. 1
2-methyl-m-phenylenediamine; 2,6-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
212-513-9
823-40-5
Muta. 2; Acute Tox. 4; Skin Sens. 1
9-vinylcarbazole
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
6-glycidyloxynapht-1-yl oxymethyloxirane
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
chrysoidine-p-dodecylbenzenesulfonate; dodecylbenzenesulfonic acid, compound with 4-(phenylazo)benzene-1,3-diamine (1:1)
264-409-8
63681-54-9
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
chrysoidine sulfate; bis[4-(phenylazo)benzene-1,3-diamine] sulfate
282-432-1
84196-22-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
chrysoidine monohydrochloride; 4-phenylazophenylene-1,3-diamine monohydrochloride
208-545-8
532-82-1
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
chrysoidine monoacetate; 4-(phenylazo)benzene-1,3-diamine monoacetate
278-290-5
75660-25-2
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
chrysoidine dihydrochloride; 4-(phenylazo)benzene-1,3-diamine dihydrochloride
281-549-5
83968-67-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
chrysoidine compound with dibutylnaphthalene sulfonic acid; dibutylnaphthalenesulfonic acid, compound with 4-(phenylazo)benzene-1,3-diamine (1:1)
304-236-8
94247-67-3
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
chrysoidine C10-14-alkyl derivatives; benzenesulfonic acid, mono-C10-14-alkyl derivatives, compounds; with 4-(phenylazo)-1,3-benzenediamine
286-946-7
85407-90-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
chrysoidine acetate; 4-(phenylazo)benzene-1,3-diamine acetate
279-116-0
79234-33-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
chrysoidine; 4-(phenylazo)benzene-1,3-diamine
207-803-7
495-54-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2
3-chloro-4-(3-fluorobenzyloxy)aniline
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
hexahydrocyclopenta[c]pyrrole-1-(1H)-ammonium N-ethoxycarbonyl-N-(p-tolylsulfonyl)azanide
AMINAZA TOLFAMATATE
418-350-1
-
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
4-ethoxyaniline; p-phenetidine
205-855-5
156-43-4
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
glyoxal...%; ethandial...%
203-474-9
107-22-2
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
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