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).

Last updated 17 June 2021. Database contains 4753 unique substances/entries.
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Skin Sens. 1
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Skin Irrit. 2
426-740-8
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Acute Tox. 4; Eye Dam. 1
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
402-460-1
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Skin Irrit. 2; Skin Sens. 1
418-960-8
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Skin Corr. 1B; Skin Sens. 1
444-320-2
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Acute Tox. 4
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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Acute Tox. 4; Skin Sens. 1
410-780-8
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Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
430-730-9
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Eye Dam. 1
419-290-9
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Skin Sens. 1
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yes
419-570-0
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Acute Tox. 4
434-120-3
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Skin Sens. 1
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Skin Irrit. 2
429-610-9
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Acute Tox. 4; Eye Dam. 1
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STOT RE 2; Eye Dam. 1; Skin Sens. 1
420-200-5
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
411-010-3
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Skin Sens. 1
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
424-700-4
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Eye Dam. 1
417-350-9
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Skin Irrit. 2; Eye Dam. 1
407-440-6
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Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
444-970-7
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Flam. Liq. 3; Repr. 2; STOT RE 2; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1; STOT SE 3
420-530-1
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Resp. Sens. 1; Skin Sens. 1
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Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
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Carc. 1B; Acute Tox. 4
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Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
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yes
426-900-7
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STOT SE 3
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yes
430-840-7
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Skin Sens. 1
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yes
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yes
410-530-8
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Skin Sens. 1
420-820-6
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Flam. Liq. 3; Acute Tox. 4
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yes
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yes
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yes
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Self-react. C; Carc. 2
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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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P Parasites
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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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