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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 24 June 2024. Database contains 4753 unique substances/entries.
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414-910-4
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Eye Dam. 1; Skin Sens. 1
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B Bacteria and similar species
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P Parasites
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P Parasites
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B Bacteria and similar species
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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.
RX-33
419-590-1
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Flam. Sol. 1; Skin Sens. 1
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B Bacteria and similar species
426-300-5
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Eye Dam. 1
REAKTIVROT 2713
412-490-7
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Skin Sens. 1
C.I. REACTIVE RED 231
402-150-6
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Eye Irrit. 2; Skin Sens. 1
425-830-4
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Eye Dam. 1
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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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B Bacteria and similar species
BROWN JR 547
419-260-5
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Eye Dam. 1
425-740-5
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Eye Dam. 1
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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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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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B Bacteria and similar species
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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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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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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.
BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
404-540-1
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Skin Sens. 1
DESBIMID
401-970-1
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Skin Sens. 1
KAYARAD R-825
405-360-6
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ADINE CP 31
401-740-0
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Acute Tox. 4
915-270-3
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yes
PK 323
401-940-8
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Acute Tox. 4; Eye Irrit. 2
X 3761
400-930-0
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
BROWN JR 543
414-150-3
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Skin Sens. 1
SUBSTANCE S166075
424-270-8
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Eye Dam. 1
UNISOL S
405-760-0
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Eye Dam. 1; Skin Sens. 1
EMULGATOR SWA; EMULVIN SWA
406-325-8
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Acute Tox. 4
430-200-7
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Eye Dam. 1
ETHOXYLATED POLYESTER RESIN
405-960-8
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Skin Sens. 1
436-890-6
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Eye Dam. 1
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
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Skin Sens. 1
MS6119
415-190-4
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Skin Sens. 1
HOSTACOR 4205 CONC.; HOSTACOR V 4205
413-500-2
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Skin Irrit. 2; Eye Dam. 1
LOVASTATIN FREE ACID
415-840-7
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Skin Sens. 1
442-480-8
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Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
433-640-8
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Pyr. Sol. 1
BLENDUR I VP KU 3-4519
421-550-1
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Carc. 1B; Repr. 1B; Skin Sens. 1
427-040-5
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Skin Corr. 1B
HFR-990
423-180-6
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STOT RE 2

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