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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
2'-(4-chloro-3-cyano-5-formyl-2-thienyl)azo-5'-diethylaminoacetanilide
BLEU 1047679; BLUE 1047679
405-200-5
104366-25-8
Skin Sens. 1
2'-(4-chloro-3-cyano-5-formyl-2-thienylazo)-5'-diethylamino-2-methoxyacetanilide
BLEU 1044098; BLUE 1044098
405-190-2
122371-93-1
Skin Sens. 1
2(or 3)-methylbutyl acetate
282-263-3
84145-37-9
Flam. Liq. 3
2,2' -oxybisethanol; diethylene glycol
203-872-2
111-46-6
Acute Tox. 4
2,2',2''-(hexahydro-1,3,5- triazine-1,3,5-triyl)triethanol;1,3,5-tris(2-hydroxyethyl)hexahydro-1,3,5-triazine
225-208-0
4719-04-4
Acute Tox. 4; Skin Sens. 1
2,2'-((3,3', 5,5'-tetramethyl-(1,1'-biphenyl)-4,4'-diyl)-bis(oxymethylene))-bis-oxirane
EPIKOTE YX4000; EPIKOTE YX4000H; YX-4000
413-900-7
85954-11-6
Carc. 2; Skin Sens. 1
2,2'-(ethylenedioxy)diethyl diacrylate; triethylene glycol diacrylate
216-853-9
1680-21-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,2'-(methylimino)diethanol; N-methyldiethanolamine
203-312-7
105-59-9
Eye Irrit. 2
2,2'-(nitrosoimino)bisethanol
214-237-4
1116-54-7
Carc. 1B
2,2'-azobis[2-methylpropionamidine] dihydrochloride
221-070-0
2997-92-4
Acute Tox. 4; Skin Sens. 1
2,2'-azobis[N-(2-hydroxyethyl)2-methylpropionamide]
2,2'-AZOBIS(2-METHYL-N-(2-HYDROXYETHYL)PROPIONAMID)
429-090-3
61551-69-7
Skin Sens. 1
2,2'-bioxirane; 1,2:3,4-diepoxybutane
215-979-1
1464-53-5
Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
2,2'-diallyl-4,4'-sulfonyldiphenol
TG-SA
411-570-9
41481-66-7
Skin Sens. 1
2,2'-dimethyl-2,2'-azodipropiononitrile; ADZN
201-132-3
78-67-1
Self-react. C; Acute Tox. 4
2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
2,2'-dithio di(ethylammonium)-bis(dibenzyldithiocarbamate)
427-180-7
239446-62-9
Acute Tox. 4; Skin Sens. 1
2,2'-iminodiethanol; diethanolamine
203-868-0
111-42-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2,2'-iminodiethylamine; diethylenetriamine
203-865-4
111-40-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2,2'-methylenebis-(3,4,6-trichlorophenol); hexachlorophene
200-733-8
70-30-4
Acute Tox. 3
2,2'-methylenediphenyl diisocyanate; diphenylmethane-2,2'-diisocyanate
219-799-4
2536-05-2
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
2,2'-oxydiethyl diacrylate; diethylene glycol diacrylate
223-791-6
4074-88-8
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,2'-thiodiethanol; thiodiglycol
203-874-3
111-48-8
Eye Irrit. 2
2,2,3,3-tetramethylbutane
209-855-6
594-82-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2,3-trimethylbutane
207-346-3
464-06-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2,3-trimethylpentane
209-266-4
564-02-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2,4-trimethyl-4-phenyl-butane-nitrile
KHUSINIL
422-580-8
75490-39-0
Acute Tox. 4
2,2,4-trimethylhexamethylene-1,6-di-isocyanate
241-001-8
16938-22-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
2,2,4-trimethylpentane
208-759-1
540-84-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2,6,6-tetrakis(bromomethyl)-4-oxaheptane-1,7-diol
FR-1034
408-020-5
109678-33-3
Skin Sens. 1
2,2-(1,4-phenylene)bis((4H—3,1-benzoxazine-4-one)
CYASORB(R) UV-3638 LIGHT STABILISER
418-280-1
18600-59-4
Skin Sens. 1
2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate
239-701-3
15625-89-5
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,2-bis(bromomethyl)propane-1,3-diol
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
2,2-bis(hydroxymethyl)butanoic acid
DMBA
424-090-1
10097-02-6
Eye Dam. 1
2,2-dialkyl-4-hydroxymethyl1,3-dioxolane; reaction products with ethylene oxide (alkyl is C1-12 and the sum to C13, average degree of ethoxylation is 3,5)
430-580-4
-
Skin Irrit. 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
2,2-dichloro-1,3-benzodioxol
426-850-6
2032-75-9
Flam. Liq. 3; Skin Corr. 1A; Acute Tox. 4; Skin Sens. 1
2,2-dichlorovinyl 2-ethylsulphinylethyl methyl phosphate
-
7076-53-1
Acute Tox. 3
2,2-diethoxy-N, N-dimethylacetamide
N,N DIMETHYL DIETHOXY-2,2 ACETAMIDE
449-950-1
34640-92-1
Eye Irrit. 2
2,2-dimethyl 3-methyl-3-butenyl propanoate
ROMILAT
415-610-6
104468-21-5
Skin Irrit. 2
2,2-dimethyl-1,3-benzodioxol-4-ol
2,3-ISOPROPYLIDENE DIOXYPHENOL
400-900-7
22961-82-6
Eye Dam. 1
2,2-dimethylbutane
200-906-8
75-83-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2-dimethylhexane
209-689-4
590-73-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2-dimethylpentane
209-680-5
590-35-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2-dimethylpropane; neopentane
207-343-7
463-82-1
Flam. Gas 1; Press. Gas
2,2-dimethyltrimethylene diacrylate; neopentyl glycol diacrylate
218-741-5
2223-82-7
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,2-ethylmethylthiazolidine
METHYL ETHYL THIAZOLIDINE
404-500-3
694-64-4
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2,3,3-trimethylpentane
209-207-2
560-21-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3,4,5-tetrachlorobenzoylchloride
2,3,4,5-TETRACHLORBENZOYLCHLORID
406-760-3
42221-52-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2,3,4,6-tetrachlorophenol
200-402-8
58-90-2
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
2,3,4-trichlorobut-1-ene
219-397-9
2431-50-7
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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