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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 24 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
propionic anhydride
204-638-2
123-62-6
Skin Corr. 1B
propionic acid ... %
201-176-3
79-09-4
Skin Corr. 1B
propineb (ISO); polymeric zinc propylenebis(dithiocarbamate)
620-365-5
9016-72-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
propiconazole(ISO); (2RS,4RS;2RS,4SR)-1-{[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl}-1H-1,2,4-triazole
262-104-4
60207-90-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
propene; propylene
204-062-1
115-07-1
Flam. Gas 1; Press. Gas
propazine (ISO);2-chloro-4,6-bis(isopropylamino)-1,3,5-triazine
205-359-9
139-40-2
Carc. 2
propargite (ISO); 2-(4-tert-butylphenoxy)cyclohexyl prop-2-ynyl sulphite
219-006-1
2312-35-8
Carc. 2; Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1
propanil (ISO); 3',4'-dichloropropionanilide
211-914-6
709-98-8
Acute Tox. 4
propane
200-827-9
74-98-6
Flam. Gas 1; Press. Gas
propanal; propionaldehyde
204-623-0
123-38-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
propan-2-ol; isopropyl alcohol; isopropanol
200-661-7
67-63-0
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
propan-1-ol; n-propanol
200-746-9
71-23-8
Flam. Liq. 2; Eye Dam. 1; STOT SE 3
propachlor (ISO); 2-chloro-N-isopropylacetanilide; α-chloro-N-isopropylacetanilide
217-638-2
1918-16-7
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
prop-2-yn-1-ol; propargyl alcohol
203-471-2
107-19-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
promecarb (ISO); 3-isopropyl-5-methylphenyl N-methylcarbamate
220-113-0
2631-37-0
Acute Tox. 3
profoxydim (ISO); 2-{(EZ)-1-[(2RS)-2-(4-chlorophenoxy)propoxyimino]butyl}-3-hydroxy-5-(thian-3-yl)cyclohex-2-en-1-one
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
profluralin (ISO);N-(cyclopropylmethyl)-α, α,α- trifluoro-2,6-dinitro-N-propyl-p-toluidine
247-656-6
26399-36-0
Eye Irrit. 2
profenofos (ISO)O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
255-255-2
41198-08-7
Acute Tox. 4
product-by-process definition polyazodyestuff obtained by coupling 4-[4-(1-amino-8-hydroxy-3,6-disulfo-2-naphthylazo)phenylsulfonylamino] benzenediazonium with reaction mass of 4-carboxybenzenediazonium and diphenylamine-3-sulfo-4,4'-bisdiazonium, and further coupling of the obtained compounds with reaction mass of naphth-2-ol and 3-aminophenol, sodium salts; sodium chloride
425-740-5
-
Eye Dam. 1
product by process iron complex of azo dyestuffs obtained by coupling a mixture of diazotized 2-amino-1-hydroxybenzene-4-sulfanilide and 2-amino-1-hydroxybenzene-4-sulfonamide with resorcin, the obtained mixture being subsequently submitted to a second coupling reaction with a mixture of diazotized 3-aminobenzene-1-sulfonic acid (metanilic acid) and 4'-amino-4-nitro-1,1'-diphenylamine-2-sulfonic acid and metallization with ferric chloride, sodium salt
BROWN JR 547
419-260-5
-
Eye Dam. 1
prochloraz (ISO);N-propyl-N-[2-(2,4,6-trichlorop henoxy)ethyl]-1H-imidazole-1- carboxamide
266-994-5
67747-09-5
Acute Tox. 4
Prevotella spp.
-
-
B Bacteria and similar species
prallethrin (ISO); ETOC; 2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
245-387-9
23031-36-9
Acute Tox. 3; Acute Tox. 4
Powassan
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
potassium, sodium 2,4-diamino-3-[4-(2-sulfonatoethoxysulfonyl)phenylazo]-5-[4-(2-sulfonatoethoxysulfonyl)-2-sulfonatophenylazo]-benzenesulfonate
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 1
Potassium titanium oxide(K2Ti6O13)
432-240-0
12056-51-8
Carc. 2
potassium tetrasodium bis[(N,N'-n)-1'-(phenylcarbamoyl)-3,5-disulfonatobenzeneazo-1'-prop-1'-ene-2,2'-diolato]chromate(III)
425-830-4
-
Eye Dam. 1
potassium sodium 6,13-dichloro-3,10-bis{2-[4-[3-(2-hydroxysulphonyloxyethanesulfonyl)phenylamino]-6-(2,5-disulfonatophenylamino)-1,3,5-triazin-2-ylamino]ethylamino}benzo[5,6][1,4]oxazino[2,3-b]phenoxazine-4,11-disulfonate
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
potassium sodium 5-(4-chloro-6-(N-(4-(4-chloro-6-(5-hydroxy-2,7-disulphonato-6-(2-sulphonatophenylazo)-4-naphthylamino)-1,3,5-triazin-2-ylamino) phenyl-N-methyl)amino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-(2-sulphonatophenylazo)naphthalene-2,7-disulphonat
C.I. REACTIVE RED 231
402-150-6
-
Eye Irrit. 2; Skin Sens. 1
potassium sodium 4-(4-chloro-6-(3,6-disulfonato-7-(5,8-disulfonato-naphthalen-2-ylazo)-8-hydroxy-naphthalen-1-ylamino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-(2-sulfatoethanesulfonyl)-phenylazo)-naphthalene-1,7-disulfonate
REAKTIVROT 2713
412-490-7
-
Skin Sens. 1
potassium sodium 3,3'-(3(or 4)-methyl-1,2-phenylenebis(imino(6-chloro)-1,3,5-triazine-4,2-diylimino(2-acetamido-5-methoxy)-4,1-phenylenazo)dinaphthalene-1,5-disulfonate
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1
potassium salt of DNOC; potassium 4,6-dinitro-o-cresolate
-
5787-96-2
Acute Tox. 3; STOT RE 2
potassium polysulphides
253-390-1
37199-66-9
Skin Corr. 1B
potassium permanganate
231-760-3
7722-64-7
Ox. Sol. 2; Repr. 2; Acute Tox. 4
potassium perfluorooctanesulfonate; potassium heptadecafluorooctane-1-sulfonate
220-527-1
2795-39-3
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
Potassium perfluorohexane-1-sulphonate
223-393-2
3871-99-6
yes
potassium perchlorate
231-912-9
7778-74-7
Ox. Sol. 1; Acute Tox. 4
potassium pentachlorophenolate
231-911-3
7778-73-6
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
potassium nitrite
231-832-4
7758-09-0
Ox. Sol. 2; Acute Tox. 3
potassium N-(4-toluenesulfonyl)-4-toluenesulfonamide
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
potassium N-(4-fluorophenyl)glycinate
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
potassium N-(1-methoxy-1-oxobut-2-en-3-yl)valinate
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
potassium mu-fluoro-bis(triethylaluminium)
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
potassium methanolate; potassium methoxide
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
potassium iron(III) 1,3-propanediamine-N, N,N',N'-tetraacetate hemihydrate
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
Potassium hydroxyoctaoxodizincatedichromate
234-329-8
11103-86-9
yes
potassium hydroxide; caustic potash
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
potassium hydrogensulphate
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
potassium fluoride
232-151-5
7789-23-3
Acute Tox. 3
potassium ferrite
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
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