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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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.

Last updated 19 April 2024. Database contains 4753 unique substances/entries.
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METHYL-TPP-CHLORID; MTPP-CHLORID
418-400-2
1031-15-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
214-446-0
1129-41-5
Acute Tox. 4
410-240-1
139528-85-1
Carc. 2; STOT RE 2
244-209-7
21087-64-9
Acute Tox. 4
232-095-1
7786-34-7
Acute Tox. 1; Acute Tox. 2
206-249-3
315-18-4
Acute Tox. 2; Acute Tox. 4
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F Fungi
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Acute Tox. 4
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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.
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1314-04-1
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
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Glass Wool EC / List no: - | CAS no: 308066-92-4
Glass, oxide, chemicals
This category encompasses the various chemical substances manufactured in the production of inorganic glasses. For purposes of this category, 'glass' is defined as an amorfous, inorganic, transparent, translucent or opaque material traditionally formed by fusion of sources of silica with a flux, such as an alkali-metal carbonate, boron oxide, etc. and a stabilizer, into a mass which is cooled to a rigid condition without crystallization in the case of transparent or liquid-phase separated glass or with controlled crystallization in the case of glass-ceramics. The category consists of the various chemical substances, other than by-products or impurities, which are formed during the production of various glasses and concurrently incorporated into a glass mixture. All glasses contain one or more of these substances, but few, if any, contain all of them. The elements listed below are principally present as components of oxide systems but some may also be present as halides or chalcogenides, in multiple oxidation states, or in more complex compounds. Trace amounts of other oxides or chemical compounds may be present. Oxides of the first seven elements listed* comprise more than 95 percent, by weight, of the glass produced. @Aluminium*@Lead@Boron*@Lithium@Calcium*@Manganese@Magnesium*@Molybdenum@Potassium*@Neodymium@Silicon*@Nickel@Sodium*@Niobium@Antimony@Nitrogen@Arsenic@Phosphorus@Barium@Praseodymium@Bismuth@Rubidium@Cadmium@Selenium@Carbon@Silver@Cerium@Strontium@Cesium@Sulfur@Chromium@Tellurium@Cobalt@Tin@Copper@Titanium@Germanium@Tungsten@Gold@Uranium@Holmium@Vanadium@Iron@Zinc@Lanthanum@Zirconium
EC / List no: 266-046-0 | CAS no: 65997-17-3
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Carc. 2
206-742-3
371-86-8
STOT SE 1
215-293-2
1319-77-3
Acute Tox. 3; Skin Corr. 1B
NUPORE G45-10
420-480-9
158570-99-1
Skin Irrit. 2; Skin Sens. 1
218-661-0
2212-67-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
268-585-7
68130-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
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12673-58-4
Carc. 1A; STOT RE 1; Skin Sens. 1
238-034-5
14177-55-0
Carc. 1A; STOT RE 1; Skin Sens. 1
215-204-7
1313-27-5
Carc. 2; Eye Irrit. 2; STOT SE 3
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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.
ICI204636 HYDROGEN FUMARATE
415-180-1
773058-82-5
Acute Tox. 4; Eye Dam. 1
200-820-0
74-89-5
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-820-0
74-89-5
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-083-3
103-16-2
Eye Irrit. 2; Skin Sens. 1
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
217-129-5
1746-81-2
Acute Tox. 4; STOT RE 2
429-570-2
213990-58-0
Skin Sens. 1
205-766-1
150-68-5
Carc. 2; Acute Tox. 4
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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.
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7411-47-4
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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29873-36-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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B Bacteria and similar species
203-815-1
110-91-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
205-628-0
144-41-2
Acute Tox. 3
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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.
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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.
248-505-7
27519-02-4
Skin Sens. 1B
201-328-9
81-14-1
Carc. 2
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species

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