EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. 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 19 srpnja 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained by the subjection of a petroleum fraction to several of the following steps: filtration, centrifugation, atmospheric distillation, vacuum distillation, acidification, neutralization, and clay treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C20.
292-615-8
90640-93-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained by dewaxing light paraffinic distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
292-614-2
90640-92-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained by dewaxing heavy paraffinic distillate. It consists predominantly of hydrocarbons having carbon numbers predominantely in the range of C20 through C50 and produces a finished oil with a viscosity of equal to or greater than 100 SUS at 100°F (19cST at 40°C). It contains relatively few normal paraffins.
292-613-7
90640-91-8
Carc. 1B
Details
The oil remaining after the removal of phenolic compounds (tar acids) from drained naphthalene oil by an alkali wash. Composed primarily of naphthalene and alkyl naphthalenes.
292-612-1
90640-90-7
Carc. 1B; Muta. 1B
Details
The aqueous extract from naphthalene oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
292-611-6
90640-89-4
Carc. 1B; Muta. 1B
Details
The aqueous extract from carbolic oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
292-610-0
90640-88-3
Carc. 1B; Muta. 1B
Details
This oil is a complex mixture of aromatic hydrocarbons, primarily indene, naphthalene, coumarone, phenol, and o-, m-, and p-cresol and boiling in the range of 140°C to 215°C (284°F to 419°F).
292-609-5
90640-87-2
Carc. 1B; Muta. 1B
Details
Distillate from the fractional distillation of coal tar of bituminous coal, with boiling range of 240°C to 400°C (464°F to 752°F). Composed primarily of tri- and polynuclear hydrocarbons and heterocyclic compounds.
292-607-4
90640-86-1
Carc. 1B
Details
The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.
292-606-9
90640-85-0
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240°C to 280°C (464°F to 536°F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.
292-605-3
90640-84-9
Carc. 1B
Details
The oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.
292-604-8
90640-82-7
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
The anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.
292-603-2
90640-81-6
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
A complex combination of polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300°C to 400°C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole
292-602-7
90640-80-5
Carc. 1B
C Carcinogenic (article 57a)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
292-456-4
90622-55-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
292-454-3
90622-53-0
Carc. 1B
Details
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90568-23-3
R Toxic for reproduction (article 57c)
Details
ADK STAB AO 80; SUMILIZER GA-80
410-730-5
90498-90-1
Acute Tox. 4
Details
291-844-0
90481-04-2
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
618-541-1
9036-19-5
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
427-880-2
90357-53-2
STOT RE 2
Details
PAYLEAN; RACTOPAMINE HYDROCHLORIDE
415-170-5
90274-24-1
Acute Tox. 4; Skin Sens. 1
Details
620-365-5
9016-72-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
500-024-6
9016-45-9
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
232-752-2
9014-01-1
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
Details
232-734-4
9012-54-8
Resp. Sens. 1
Details

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