Registration Dossier

Manufacture, use & exposure

Uses by professional workers

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Uses by professional workers

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC8c: Widespread use leading to inclusion into/onto article (indoor)
Contributing activity / technique for workers
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Product category used:
PC 32: Polymer preparations and compounds
Sector of end use:
SU 0: Other: medical devices
Substance supplied to that use in form of:
in a mixture
Subsequent service life relevant to this use:
no

Uses by professional workers

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC8c: Widespread use leading to inclusion into/onto article (indoor)
Contributing activity / technique for workers
Process category (PROC):
PROC 19: Hand-mixing with intimate contact and only PPE available.
Product category used:
PC 0: Other: medical device
Sector of end use:
SU 20: Health services
Substance supplied to that use in form of:
in a mixture
Subsequent service life relevant to this use:
yes

Uses by professional workers

Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported <10tonnes/year per registrant
Contributing activity / technique for the environment
Name of activity / technique:
Application, whole process
Environmental release category (ERC):
ERC8c: Widespread use leading to inclusion into/onto article (indoor)
Contributing activity / technique for workers
Name of activity / technique:
whole application
Process category (PROC):
PROC 19: Hand-mixing with intimate contact and only PPE available.
Product category used:
PC 0: Other: medical device
Sector of end use:
SU 20: Health services
Substance supplied to that use in form of:
in a mixture
Subsequent service life relevant to this use:
yes

Uses by professional workers

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC9b: Widespread use of functional fluid (outdoor)
Contributing activity / technique for workers
Process category (PROC):
PROC 21: Low energy manipulation of substances bound in materials and/or articles
Product category used:
PC 0: Other: medical devices
Sector of end use:
SU 20: Health services
Substance supplied to that use in form of:
in a mixture
Subsequent service life relevant to this use:
yes

Uses by professional workers

Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported <10tonnes/year per registrant
Contributing activity / technique for the environment
Name of activity / technique:
Machining, whole process
Environmental release category (ERC):
ERC9a: Widespread use of functional fluid (indoor)
Contributing activity / technique for workers
Name of activity / technique:
Machining rods
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Product category used:
PC 0: Other: medical devies
Sector of end use:
SU 20: Health services
Substance supplied to that use in form of:
in a mixture
Subsequent service life relevant to this use:
yes
Insignificant exposure via the following route:
inhalatory
Insignificant release via the following route:
water
Pattern of exposure:
accidental / infrequent

Uses by professional workers

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC9a: Widespread use of functional fluid (indoor)
Contributing activity / technique for workers
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Product category used:
PC 0: Other: medical devies
Sector of end use:
SU 20: Health services
Substance supplied to that use in form of:
in a mixture
Subsequent service life relevant to this use:
yes

Uses by professional workers

Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported <10tonnes/year per registrant
Contributing activity / technique for the environment
Name of activity / technique:
All mixture and polymer curing activies
Environmental release category (ERC):
ERC8c: Widespread use leading to inclusion into/onto article (indoor)
Contributing activity / technique for workers
Name of activity / technique:
Mixing and curing mixture
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Product category used:
PC 32: Polymer preparations and compounds
Sector of end use:
SU 0: Other: medical devices
Substance supplied to that use in form of:
in a mixture
Subsequent service life relevant to this use:
no
Insignificant exposure via the following route:
inhalatory
Insignificant release via the following route:
water
Pattern of exposure:
accidental / infrequent

Uses by professional workers

Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported <10tonnes/year per registrant
Contributing activity / technique for the environment
Name of activity / technique:
All activities
Environmental release category (ERC):
ERC9b: Widespread use of functional fluid (outdoor)
Contributing activity / technique for workers
Name of activity / technique:
Use for corono-radicular reconstruction
Process category (PROC):
PROC 21: Low energy manipulation of substances bound in materials and/or articles
Product category used:
PC 0: Other: medical devices
Sector of end use:
SU 20: Health services
Substance supplied to that use in form of:
in a mixture
Subsequent service life relevant to this use:
yes
Insignificant exposure via the following route:
oral
Insignificant release via the following route:
water
Pattern of exposure:
occasional