EU-MEDICAL_DEVICES-ANX_I_7_8

Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Directive 93/42/EEC, 12 July 1993, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). Specifically, the 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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021.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
5-methylhexan-2-one; isoamyl methyl ketone
203-737-8
110-12-3
Flam. Liq. 3; Acute Tox. 4
5-methylpyrazine-2-carboxylic acid
5-METHYLPYRAZINE-2-CARBOXYLIC ACID; ACIDO 5-METILPIRAZIN CARBOSSILICO
413-260-9
5521-55-1
Eye Dam. 1
5-nitro-o-toluidine
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
5-nitro-o-toluidine hydrochloride
256-960-8
51085-52-0
Carc. 2; Acute Tox. 3
5-nitroacenaphthene
210-025-0
602-87-9
Carc. 1B
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane
-
-
yes
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]
-
-
yes
5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane
-
-
yes
5-tert-butyl-3-isoxazolylamine hydrochloride
BISOX HCL
404-840-2
164578-13-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
5-thiazolylmethanol
A-87440.0; A-87440.00
414-780-9
38585-74-9
Eye Dam. 1
5-{4-[5-amino-2-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-sulfo-phenylamino]-6-chloro-1,3,5-triazin-2-ylamino}-4-hydroxy-3-(1-sulfo-naphthalen-2-ylazo)-naphthalene-2,7-disulfonicacid sodium salt
ROUGE TZ 4075
418-340-7
157707-94-3
Eye Dam. 1
6,13-dichloro-3,10-bis{2-[4-fluoro-6-(2-sulfophenylamino)-1,3,5-triazin-2-ylamino]propylamino}benzo[5,6][1,4]oxazino[2,3-.b.]phenoxazine-4,11-disulphonic acid, lithium-, sodium salt
BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
6,6'-bis(diazo-5,5', 6,6'-tetrahydro-5,5'-dioxo)[methylene-bis(5-(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulphonyloxy)-6-methyl-2-phenylene]di(naphthalene-1-sulfonate)
441-550-5
-
Self-react. C; Carc. 2
6,7-dihydrodipyrido[1,2-α:2',1'- c]pyrazinediylium dihydroxide
301-467-6
94021-76-8
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
6-(1α,5aβ,8aβ,9-pentahydroxy-7β-isopropyl-2β,5β,8β-trimethylperhydro-8bα,9-epoxy-5,8-ethanocyclopenta[1,2-b]indenyl) pyrrole-2-carboxylate; ryania
239-732-2
15662-33-6
Acute Tox. 4
6-(2,3-dimethylmaleimido)hexyl methacrylate
RONACAT RO 305; RONACOAT RO 305
404-870-6
63740-41-0
Skin Sens. 1
6-(nonylamino)-6-oxo-peroxyhexanoic acid
ELFADOX EN 3001
406-680-9
104788-63-8
Org. Perox. C; Eye Dam. 1; Skin Sens. 1
6-(phthalimido)peroxyhexanoic acid
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 1
6-dimethylaminohexan-1-ol
AF-507; M-3181
404-680-3
1862-07-3
Acute Tox. 4; Skin Corr. 1B
6-docosyloxy-1-hydroxy-4-(1-(4-hydroxy-3-methylphenanthren-1-yl)-3-oxo-2-oxaphenalen-1-yl)naphthalene-2-carboxylic acid
ENS 131
404-550-6
130263-41-1
Skin Sens. 1
6-ethyl-5-fluoro-4(3H)-pyrimidone
UK-103,442
422-460-5
137234-87-8
Acute Tox. 4
6-fluoro-2-methyl-3-(4-methylthiobenzyl)indene
IN-4; INDENE IN-4
405-410-7
41201-60-9
Skin Irrit. 2; Eye Dam. 1; 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
6-hydroxy-1-(3-isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecarbonitrile
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
6-hydroxyindole
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
6-methoxy-m-toluidine; p-cresidine
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
6-methyl-2,4-bis(methylthio)phenylene-1,3-diamine
DM-C-TDA; DMTDA; ETHACURE (R) 300 CURATIVE
403-240-8
106264-79-3
Acute Tox. 4; Skin Sens. 1
6-phenyl-1,3,5-triazine-2,4- diyldiamine; 6-phenyl-1,3,5-triazine-2,4-diamine; benzoguanamine
202-095-6
91-76-9
Acute Tox. 4
7,7-dimethyl-3-oxa-6-azaoctan-1-ol
FLEXSORB-SE
400-390-6
87787-67-5
Skin Corr. 1A; Acute Tox. 4
7-[((4,6-dichloro-1,3,5-triazin-2-yl)amino)-4-hydroxy-3-(4-((2-sulfoxy)ethyl)sulfonyl)phenylazo]naphthalene-2-sulfonic acid
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
7-amino-3-((5-carboxymethyl-4- methyl-1,3-thiazol-2- ylthio)methyl)-8-oxo-5-thia-1- azabicyclo(4.2.0)oct-2-ene-2- carboxylic acid
TACS
403-690-5
111298-82-9
Resp. Sens. 1; Skin Sens. 1
7-amino-4-hydroxy-2-naphthalenesulfonic acid, coupled with 5 (or 8) -amino-8 (or 5)-[[4-[[4-[[4-amino-6(or 7)-sulfo-1-naphthyl]azo]phenyl]amino]-3-sulfophenyl]azo]-2-naphthalenesulfonic acid and 4-hydroxy-7-(phenylamino)-2-naphthalenesulfonic acid, sodium salt
424-850-0
189702-72-5
Eye Dam. 1
7-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid
FLUORCHINOLONCARBONSÄURE
405-050-0
86393-33-1
Acute Tox. 4
7-methoxy-6-(3-morpholin-4-yl-propoxy)-3H-quinazolin-4-one [containing ≥ 0,5 % formamide (EC No 200-842-0)]
429-400-7
199327-61-2
Repr. 1B
7-methylocta-1,6-diene
7-METHYL-1,6-OCTADIENE
404-210-7
42152-47-6
Flam. Liq. 3
7a-ethyl-3,5-bis(1-methylethyl)-2,3,4,5-tetrahydrooxazolo[3,4-c]-2,3,4,5-tetrahydrooxazole
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
8,8-dimethyl-7-isopropyl-6,10-dioxaspiro[4.5]decane
OPALAL
424-030-2
62406-73-9
Skin Irrit. 2
8,9,10-trinorborn-2-yl acrylate
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
8,9-dinorborn-5-ene-2,3-dicarboxylic anhydride
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
8-amino-7-methylquinoline
8-AMINO-7-METHYLCHINOLIN
412-760-4
5470-82-6
Acute Tox. 4; Skin Sens. 1
8-azaspiro[4.5]decane-7,9-dione
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
8-p-menthyl hydroperoxide; p-menthane hydroperoxide
201-281-4
80-47-7
Org. Perox. D; Skin Corr. 1B; Acute Tox. 4
9,9-bis(4-hydroxyphenyl)fluorene
BPFL; FLUOREN-BIS-PHENOL
406-950-6
3236-71-3
Eye Irrit. 2; Skin Irrit. 2
9-(2-propenyloxy)tricyclo[5.2.1.0(2,6)]dec-3(or-4-)-ene
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
9-vinylcarbazole
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
[(1-methyl-1,2-ethanediyl)bis[nitrilobis(methylene)]]tetrakis(phosphonic acid)
421-940-1
28698-31-9
Eye Dam. 1
[(4S, 5S)-4-benzyl-2-oxo-5-oxazolidinyl]methyl 4-nitrobenzenesulfonate
416-360-0
162221-28-5
Skin Sens. 1
[(dimethylsilylene)bis((1,2,3,3a,7a-η)-1H-inden-1-ylidene)dimethyl]hafnium
M1
422-060-0
137390-08-0
Acute Tox. 2
[(m-tolyloxy)methyl]oxirane
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
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