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).

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Last updated 16 April 2024. Database contains 4917 unique substances/entries.
Substance Name EC No. CAS No. EU CLP (1272/2008) EU REACH: List of SVHC EU_BA Directive 2000/54/EC  
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; STOT SE 3; Eye Dam. 1
Details
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details

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