ISO 10451:2010 PDF
Dentistry — Contents of technical file for dental implant systems
Dentistry — Contents of technical file for dental implant systems
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 8
- Дата публикации:
- 7 июня 2010 г.
- Издание:
- ISO IS 10451 edition 2 version 1
- ICS:
- 11.060.15
ISO 10451:2010 specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof that remains in the mouth after surgery.
Abstract
Overview
ISO 10451:2010 - Dentistry - Contents of technical file for dental implant systems specifies the minimum documentation a manufacturer should include in a technical file to demonstrate fulfilment of regulatory requirements for dental implants and prefabricated parts that remain in the mouth after surgery. The standard clarifies what evidence is expected for design, materials, manufacturing, sterilization, biological and clinical evaluation, risk management, packaging, labelling and instructions for use.
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