TÜV RHEINLAND Product Safety
GmbH
Pastfach 91 09 51
Benannt für Am Grauen Stein
51101 Köln
GERMANY
T : 00 49 221 806 2004
F : 00 49 221 806 3935
URL :
Email :
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Non-active medical devices der Klassen I
steril/mit
MeBfukition (*), IIa und IIb :
- orthopaedic implants
- soft-tissue implants
- function implants
- disposable medical
devices
- anaesthetic, orthopaedic and
rehabilitation products
- non-energy medical
instrumentation
- reusable non-active medical
instruments
- bandages and dressings
- suture material and
clamps
- dental equipment and
instruments
- dental materials
- dental implants
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Full quality assurance
Type-examination
Production quality assurance
Product quality assurance
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Annex II
Annex III
Annex V
Annex VI
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Active medical devices :
- devices to ascertain vital
functions
- equipment for extracorporeal
circuits, infusions and haemophoresis
- anaesthesia devices, incubators,
respirators and oxygen therapy equipment
- surgical equipment and ancillary
surgical equipment
- imaging equipment :
- with ionizing
radiation
- with non-ionizing
radiation
- stimulation devices
- radiotherapy devices :
- with ionizing
radiation
- with non-ionizing
radiation
- ophtalmological devices
- dental equipment
- protheses and rehabilitation
devices
- disinfection and sterilization
equipment
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Full quality assurance
Type-examination
EC verification
Production quality assurance
Product quality assurance
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Annex II
Annex III
Annex IV
Annex V
Annex VI
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