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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 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
(Z)-2-methoxymino-2-[2-(tritylamino)thiazol-4-yl]acetic acid
431-520-1
64485-90-1
Flam. Sol. 1; Carc. 2
1,1-dimethylpropyl 3,5,5-trimethylperoxyhexanoate
LUPEROX 570
431-610-9
68860-54-8
Org. Perox. D; Skin Sens. 1
1,10-phenanthroline
200-629-2
66-71-7
Acute Tox. 3
1,2,3,4,5,6-hexachlorcyclohexanes with the exception of those specified elsewhere in this Annex
210-168-9
608-73-1
Carc. 2; Acute Tox. 3; Acute Tox. 4
1,2,3,4-tetranitrocarbazole
-
6202-15-9
Expl. 1.1; Acute Tox. 4
1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters
271-094-0
68515-51-5
yes
1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear
271-093-5
68515-50-4
Repr. 1B
yes
1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters
272-013-1
68648-93-1
yes
1,2-benzenedicarboxylic acid; di-C7-11-branched and linear alkylesters
271-084-6
68515-42-4
Repr. 1B
yes
1,2-diethoxyethane
211-076-1
629-14-1
Flam. Liq. 2; Repr. 1A; Eye Irrit. 2
yes
1,2-dihydro-6-hydroxy-4-methyl-1-[3-(1-methylethoxy)propyl]-2-oxo-3-pyridinecarbonitrile
FAT 92'364/A
411-990-2
68612-94-2
Skin Sens. 1
1,3-dioxolane
211-463-5
646-06-0
Flam. Liq. 2
1-(1-naphthylmethyl)quinolinium chloride
CIB R634
406-220-7
65322-65-8
Carc. 2; Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
1-benzyl-5-ethoxyimidazolidine-2,4-dione
BEH; FC-05; FCO5; WMT 1155
417-340-4
65855-02-9
Acute Tox. 4
1-benzylimidazolidine-2,4-dione
T-5914 AND 501006025007
421-340-1
6777-05-5
Acute Tox. 4
1-chloro-1-nitropropane
209-990-0
600-25-9
Acute Tox. 4
1-dimethylcarbamoyl-5-methyl pyrazol-3-yl dimethylcarbamate; dimetilan (ISO)
211-420-0
644-64-4
Acute Tox. 3; Acute Tox. 4
1-ethyl-1-methylmorpholinium bromide
MEM
418-250-8
65756-41-4
Muta. 2
1-ethyl-1-methylpyrrolidinium bromide
MEP
418-200-5
69227-51-6
Muta. 2
1-methylbutyl acetate
210-946-8
626-38-0
Flam. Liq. 3
1-methylimidazole
210-484-7
616-47-7
Acute Tox. 4; Skin Corr. 1B
1-phenylethylamine;DL-α-methylbenzylamine
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
1-phenylethylamine;DL-α-methylbenzylamine
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
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'-dimethyl-4,4'-methylenebis(cyclohexylamine)
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
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-ethylmethylthiazolidine
METHYL ETHYL THIAZOLIDINE
404-500-3
694-64-4
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2,3,5,6-tetrafluorobenzoic acid
2,3,5,6-TETRAFLUROROBENZOIC ACID; SUBSTANCE TFBA
416-800-1
652-18-6
Skin Irrit. 2; Eye Dam. 1
2,3-dichloro-5-trifluoromethyl- pyridine
DCTFMP
410-340-5
69045-84-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2,3-dihydro-2,2-dimethyl-1H-perimidine
424-060-6
6364-17-6
Acute Tox. 4; STOT RE 2; Skin Sens. 1
2,3-dinitrophenol
200-628-7
66-56-8
Acute Tox. 3; STOT RE 2
2,3-dinitrotoluene
210-013-5
602-01-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
2,4,6-tri-n-propyl-2,4,6-trioxo-1,3,5,2,4,6-trioxatriphosphorinane
T3P
422-210-5
68957-94-8
Skin Corr. 1B
2,4,6-trinitro-m-cresol
210-027-1
602-99-3
Expl. 1.1; Acute Tox. 4
2,4,6-trinitro-m-xylene
211-187-5
632-92-8
Expl. 1.1; Acute Tox. 4; STOT RE 2
2,4,6-trinitroanisole
620-419-8
606-35-9
Expl. 1.1; Acute Tox. 4
2,4-diaminoanisole; 4-methoxy-m-phenylenediamine
210-406-1
615-05-4
Carc. 1B; Muta. 2; Acute Tox. 4
2,5-dinitrotoluene
210-581-4
619-15-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
2,6-dinitrotoluene
210-106-0
606-20-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
2-(10-oxo-10H-9-oxa-10-phosphaphenanthren-10-ylmethyl)succinic acid
426-480-5
63562-33-4
Skin Sens. 1
2-[3-(methylamino)propyl]-1H-benzimidazole
425-760-4
64137-52-6
Eye Dam. 1
2-amino-6-ethoxy-4-methylamino-1,3,5-triazine
DPX-D-7556
403-580-7
62096-63-3
Acute Tox. 4
2-chloro-3-trifluoromethylpyridine
424-520-6
65753-47-1
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
2-chloropentane
210-885-7
625-29-6
Flam. Liq. 2; Acute Tox. 4
2-cyclopentylidene cyclopentanol 1,1'-bi(cyclopentyliden)-2-ol
434-270-1
6261-30-9
Skin Irrit. 2; Eye Dam. 1
2-fluoro-5-trifluoromethylpyridine
G.1417
400-290-2
69045-82-5
Flam. Liq. 3; Skin Sens. 1
2-fluoroacetamide
211-363-1
640-19-7
Acute Tox. 2; Acute Tox. 3
2-hydroxymethyl-9-methyl-6-(1-methylethyl)-1,4-dioxaspiro[4.5]decane
FRESCOLAT MGA
408-200-3
63187-91-7
Skin Irrit. 2; Eye Dam. 1
2-methyl-p-phenylenediamine sulphate
228-871-4
6369-59-1
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
2-methyl-p-phenylenediamine sulphate
210-431-8
615-50-9
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
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