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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
2,2'-(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'-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'-dichloro-4,4'-methylenedianiline; 4,4'-methylene bis(2-chloroaniline)
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
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'-thiodiethanol; thiodiglycol
203-874-3
111-48-8
Eye Irrit. 2
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
2,2,6,6-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(hydroxymethyl)butanoic acid
DMBA
424-090-1
10097-02-6
Eye Dam. 1
2,2-dimethyl 3-methyl-3-butenyl propanoate
ROMILAT
415-610-6
104468-21-5
Skin Irrit. 2
2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propionic acid
236-236-8
13252-13-6
yes
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (Z)-(1R,3R)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate; epsilon-momfluorothrin
-
1065124-65-3
Acute Tox. 4; STOT SE 2
2,3-bis((2-mercaptoethyl)thio)-1-propanethiol
MR-7 B; MR-8 B2; MR-S2
411-290-7
131538-00-6
Acute Tox. 4; STOT RE 2
2,3-epoxypropyl acrylate; glycidyl acrylate
203-440-3
106-90-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2,3-epoxypropyl methacrylate; glycidyl methacrylate
203-441-9
106-91-2
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; STOT RE 1; Eye Dam. 1; Skin Corr. 1C; Skin Sens. 1
2,3-epoxypropyl-2-ethylcyclohexyl ether; ethylcyclohexylglycidyl ether
-
130014-35-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,4,4-trimethylhexamethylene-1,6-di-isocyanate
239-714-4
15646-96-5
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
2,4,4-trimethylpent-1-ene
203-486-4
107-39-1
Flam. Liq. 2
2,4,5-trimethylaniline
205-282-0
137-17-7
Carc. 1B; Acute Tox. 3
2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane; metaldehyde
203-600-2
108-62-3
Flam. Sol. 2; Repr. 2; Acute Tox. 3
2,4,6-tri-tert-butylphenyl 2-butyl-2-ethyl-1,3-propanediolphosphite
423-560-1
161717-32-4
Skin Sens. 1
2,4,6-trichloro-1,3,5-triazine; cyanuric chloride
203-614-9
108-77-0
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2,4,6-trimethyl-1,3,5-trioxane; paraldehyde
204-639-8
123-63-7
Flam. Liq. 3
2,4,6-trinitrotoluene; TNT
204-289-6
118-96-7
Expl. 1.1; Acute Tox. 3; STOT RE 2
2,4-bis(((2-(dimethylammonio)ethyloxy)carbonyl)phen-2-ylazo)benzene-1,3-diol sulfate
429-610-9
1030366-98-3
Acute Tox. 4; Eye Dam. 1
2,4-bis(((2-(dimethylammonio)ethyloxy)carbonyl)phen-2-ylazo)benzene-1,3-diolbis(methanesulfonate)
429-600-4
1026988-42-0
Acute Tox. 4; Eye Dam. 1
2,4-bis[2,2'-[2-(N, N-dimethylamino)ethyloxycarbonyl]phenylazo]-1,3-dihydroxybenzene, dihydrochloride
BASISCH GELB 8511
407-010-8
118208-02-9
Acute Tox. 4; Eye Dam. 1
2,4-di-tert-butylcyclohexanone
CYCLOWOOD
405-340-7
13019-04-0
Skin Irrit. 2
2,4-dichloro-3-ethylphenol
PM 9879
401-060-4
121518-45-4
Skin Corr. 1B
2,4-dichlorophenol
204-429-6
120-83-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
2,4-dihydro-4-(4-(4-(4-hydroxyphenyl)-1-piperazinyl)phenyl)-2-(1-methylpropyl)-3H-1,2,4-triazol-3-one
434-820-9
106461-41-0
STOT RE 2
2,4-dihydroxy-N-(2-methoxyphenyl)benzamide
ADK ARKLS SV-3
419-090-1
129205-19-2
Skin Sens. 1
2,4-dimethyl-6-(1-methyl-pentadecyl)phenol
CG 27-145
411-220-5
134701-20-5
Skin Irrit. 2; Skin Sens. 1
2,4-dimethylpentane
203-548-0
108-08-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,4-dinitrotoluene
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
2,4-xylenol
203-321-6
105-67-9
Acute Tox. 3; Skin Corr. 1B
2,5,7,7-tetramethyloctanal
LYRISAL
405-690-0
114119-97-0
Skin Irrit. 2; Skin Sens. 1
2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane
MR-8A; MR-N2; NBDI
411-280-2
161973-12-2
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
2,5-dihydroxy-5-methyl-3-(morpholin-4-yl)-2-cyclopenten-1-one
430-170-5
114625-74-0
Acute Tox. 4
2,5-dimercaptomethyl-1,4-dithiane
HR-11
419-770-8
136122-15-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2,6-bis(2,3,4-trihydroxybenzyl)-p-cresol ester with 6-diazo-5,6-dihydro-5-oxo-1-naphthalenesulfonate
444-250-2
144111-81-9
Self-react. C
2,6-bis-(2-(4-(4-amino-phenylamino)-phenylazo)-1,3-dimethyl-3H-imidazolium)-4-dimethylamino-1,3,5-triazine, dichloride
VIOLETT MIP 3250
424-120-1
174514-06-8
Eye Dam. 1
2,6-dichloro-1-fluoropyridiniumtetrafluoroborate
FPB 800
427-400-1
140623-89-8
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
2,6-dichloro-4-nitroanisole
T 1049
403-350-6
17742-69-7
Acute Tox. 3
2,6-dimethylheptan-4-one; di-isobutyl ketone
203-620-1
108-83-8
Flam. Liq. 3; STOT SE 3
2,7,11-trimethyl-13-(2,6,6-trimethylcyclohex-1-en-1-yl)tridecahexaen-2,4,6,8,10,12-al
C25-ALDEHYD
415-770-7
1638-05-7
STOT RE 2; Skin Sens. 1
2,9-bis(3-(diethylamino)propylsulfamoyl)quino(2,3-b)acridine-7,14-dione
PIGMENT ADDITIV AC; PIGMENTADDITIV AC
404-230-6
164578-11-4
Skin Sens. 1
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