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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
propineb (ISO); polymeric zinc propylenebis(dithiocarbamate)
620-365-5
9016-72-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
propionic acid ... %
201-176-3
79-09-4
Skin Corr. 1B
propionic anhydride
204-638-2
123-62-6
Skin Corr. 1B
propionyl chloride
201-170-0
79-03-8
Flam. Liq. 2; Skin Corr. 1B
propoxur (ISO); 2-isopropyloxyphenyl N-methylcarbamate; 2-isopropoxyphenyl methylcarbamate
204-043-8
114-26-1
Acute Tox. 3
propyl 3,4,5-trihydroxybenzoate
204-498-2
121-79-9
Acute Tox. 4; Skin Sens. 1
propyl acetate
203-686-1
109-60-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
propyl chloroformate; chloroformic acid propylester; n-propyl chloroformate
203-687-7
109-61-5
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
propyl formate
203-798-0
110-74-7
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
propyl propionate
203-389-7
106-36-5
Flam. Liq. 3; Acute Tox. 4
propylbenzene
203-132-9
103-65-1
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3
propylene carbonate
203-572-1
108-32-7
Eye Irrit. 2
propylene oxide; 1,2-epoxypropane; methyloxirane
200-879-2
75-56-9
Flam. Liq. 1; Carc. 1B; Muta. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
yes
propylenediamine
201-155-9
78-90-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
propylenethiourea
620-432-9
2122-19-2
Repr. 2; Acute Tox. 4
propyzamide (ISO); 3,5-dichloro-N-(1,1-dimethylprop-2-ynyl)benzamide
245-951-4
23950-58-5
Carc. 2
proquinazid (ISO); 6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one
606-168-7
189278-12-4
Carc. 2
Prospect Hill virus
-
-
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.
prosulfocarb (ISO); S-benzyl N, N-dipropylthiocarbamate
PROSULFOCARB
401-730-6
52888-80-9
Acute Tox. 4; Skin Sens. 1
prosulfuron (ISO); 1-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)phenylsulfonyl]urea
619-000-2
94125-34-5
Acute Tox. 4
proteases with the exception of those specified elsewhere in this Annex
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Proteinase, Bothrops atrox serine EC / List no: 232-918-4 | CAS no: 9039-61-6
Proteinase, oryzin EC / List no: 232-992-8 | CAS no: 9081-30-5
Amylase, mixed with proteinase, Bacillus thuringiensis-fermented EC / List no: - | CAS no: 68909-36-4
Proteinase, Staphylococcus aureus serine EC / List no: 259-611-8 | CAS no: 55354-32-0
Proteinase, microbial acid EC / List no: 256-862-5 | CAS no: 50936-52-2
Proteinase, Aspergillus neutral EC / List no: 278-588-5 | CAS no: 77000-13-6
Proteinase, rhizopus acid EC / List no: 812-486-9 | CAS no: 9074-09-3
Proteinase, Mucor aspartic EC / List no: 232-975-5 | CAS no: 9073-79-4
Proteinase, Aspergillus oryzae neutral EC / List no: 232-990-7 | CAS no: 9080-55-1
Proteinase, microbial neutral EC / List no: 232-966-6 | CAS no: 9068-59-1
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Proteinase, Serratia extracellular EC / List no: 253-457-5 | CAS no: 37312-62-2
Proteinase, Bacillus subtilis EC / List no: 257-520-8 | CAS no: 51931-23-8
Proteinase, pancreatic EC / List no: 232-626-7 | CAS no: 9001-72-3
Proteinase, Myxobacter AL-1, II EC / List no: 276-716-4 | CAS no: 72561-05-8
Proteinase, serine EC / List no: 253-431-3 | CAS no: 37259-58-8
Proteinase, Endothia aspartic EC / List no: 253-395-9 | CAS no: 37205-60-0
Proteinase, Aspergillus alkaline EC / List no: 232-977-6 | CAS no: 9074-07-1
Proteinase, bacterial E 30 serine EC / List no: - | CAS no: 39369-34-1
Thrombin EC / List no: 232-648-7 | CAS no: 9002-04-4
Proteinase, Agkistrodon serine EC / List no: 232-933-6 | CAS no: 9046-56-4
Proteinase, Bacillus licheniformis serine EC / List no: 279-361-3 | CAS no: 79986-26-8
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Proteinase, Aspergillus melleus, semialkaline EC / List no: - | CAS no: 76106-83-7
Proteinase, Bacillus subtilis metallo- EC / List no: 232-991-2 | CAS no: 9080-56-2
Bacillus megaterium protease fermentation product EC / List no: - | CAS no: 68909-17-1
Proteinase, aspartic EC / List no: 278-856-1 | CAS no: 78169-47-8
Proteinase, Bacillus neutral EC / List no: 278-547-1 | CAS no: 76774-43-1
Aspergillin M EC / List no: - | CAS no: 42615-60-1
Proteinase, microbial alkaline EC / List no: 256-863-0 | CAS no: 50936-53-3
Proteinase, serine (Tritirachium album) EC / List no: 686-165-5 | CAS no: 102925-54-2
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Myxobacteralphalyticproteinase EC / List no: - | CAS no: 12585-31-8
Proteinase, Bacillus alcalophilus serine EC / List no: 306-090-0 | CAS no: 95979-76-3
Proteinase, submandibular gland serine, A EC / List no: 279-893-6 | CAS no: 82047-85-6
Proteinase, Aspergillus parasiticus neutral EC / List no: 254-418-5 | CAS no: 39335-09-6
Proteinase, Aspergillus acid EC / List no: 232-796-2 | CAS no: 9025-49-4
Proteinase, Tritirachium album serine EC / List no: 254-457-8 | CAS no: 39450-01-6
Proteinase, Bacillus subtilis, sutilain EC / List no: 235-390-3 | CAS no: 12211-28-8
Proteinase, Streptomyces griseus EC / List no: 232-909-5 | CAS no: 9036-06-0
Proteinase, Aspergillus niger neutral EC / List no: 254-422-7 | CAS no: 39346-39-9
Proteinase, Bacillus alkaline EC / List no: 232-972-9 | CAS no: 9073-77-2
Proteinase, Myxobacter α-lytic EC / List no: 253-448-6 | CAS no: 37288-76-9
Proteinase, Bacillus polymyxa neutral EC / List no: 255-914-4 | CAS no: 42613-33-2
Proteinase, Bacillus subtilis serine EC / List no: 266-557-9 | CAS no: 67051-83-6
934-013-6
39450-01-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
proteinase, microbial neutral
232-966-6
9068-59-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Proteus mirabilis
-
-
B Bacteria and similar species
Proteus penneri
-
-
B Bacteria and similar species
Proteus vulgaris
-
-
B Bacteria and similar species
prothoate (ISO); O,O-diethyl isopropylcarbamoylmethyl phosphorodithioate
218-893-2
2275-18-5
Acute Tox. 1; Acute Tox. 2
Providencia alcalifaciens
-
-
B Bacteria and similar species
Providencia rettgeri
-
-
B Bacteria and similar species
Providencia spp.
-
-
B Bacteria and similar species
proxan-sodium (ISO); sodium O-isopropyldithiocarbonate
205-443-5
140-93-2
Acute Tox. 4; Skin Irrit. 2
Pseudomonas aeruginosa
-
68583-29-9
B Bacteria and similar species
Puumala virus
-
-
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.
pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one
602-927-1
123312-89-0
Carc. 2; Repr. 2
pyraclostrobin (ISO); methyl N-{2-[1-(4-chlorophenyl)-1H-pyrazol-3-yloxymethyl]phenyl}(N-methoxy)carbamate
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
pyrazole-1-carboxamidine monohydrochloride
429-520-1
4023-02-3
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
pyrazophos (ISO); O, O-diethyl O-(6-ethoxycarbonyl-5-methylpyrazolo[2,3-a]pyrimidin-2-yl) phosphorothioate
236-656-1
13457-18-6
Acute Tox. 4
pyrazoxon; diethyl 3-methylpyrazol-5-yl phosphate
-
108-34-9
Acute Tox. 2; Acute Tox. 1
Pyrene
204-927-3
129-00-0
yes
pyrethrins including cinerins, with the exception of those specified elsewhere in this Annex
-
-
Acute Tox. 4
pyridaben (ISO); 2-tert-butyl-5-(4-tert-butylbenzylthio)-4-chloropyridazin-3(2H)-one
PYRIDABEN
405-700-3
96489-71-3
Acute Tox. 3
pyridate (ISO); O-(6-chloro-3-phenylpyridazin-4-yl) S-octyl thiocarbonate
259-686-7
55512-33-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
pyridine
203-809-9
110-86-1
Flam. Liq. 2; Acute Tox. 4
Pyridine, alkyl derivs.; Crude Tar Bases [The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approxi mately above 150o C (302oF) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.]
The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150°C (302°F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.
269-929-9
68391-11-7
Carc. 1B; Muta. 1B
pyrithione zinc; (T-4)-bis[1-(hydroxy-κO)pyridine-2(1H)-thionato-κS]zinc
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
Pyrochlore, antimony lead yellow
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
yes
pyrogallol; 1,2,3-trihydroxybenzene
201-762-9
87-66-1
Muta. 2; Acute Tox. 4
pyroquilon (ISO);1,2,5,6-tetrahydropyrrolo[3,2,1- ij]quinolin-4-one
611-516-6
57369-32-1
Acute Tox. 4
pyroxsulam (ISO); N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-(trifluoromethyl)pyridine-3-sulfonamide
610-007-6
422556-08-9
Skin Sens. 1
quaternary ammonium compounds, benzyl-C8-18-alkyldimethyl, chlorides
264-151-6
63449-41-2
Acute Tox. 4; Skin Corr. 1B
quinalphos (ISO); O, O-diethyl-O-quinoxalin-2-yl phosphorothioate
237-031-6
13593-03-8
Acute Tox. 3; Acute Tox. 4
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