SFS-EN ISO 10451:en

Soveltamisala

Suomenkielistä soveltamisalaa ei ole saatavissa.

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.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.

Sisällysluettelo

Tuoteryhmä(t)

11.060.15 Hammasimplantit »

Sidokset

Velvoittavat viittaukset

ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
ISO 10993-9:2009 Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products

ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
ISO 10993-9:2009 Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
ISO 11135-1:2007 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2006 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
ISO 11137-3:2006 Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects
ISO 11607-1:2006 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
ISO 129-1:2004 Technical drawings -- Indication of dimensions and tolerances -- Part 1: General principles
ISO 14155-1:2003 Clinical investigation of medical devices for human subjects -- Part 1: General requirements
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects -- Part 2: Clinical investigation plans
ISO 14405-2:2011 Geometrical product specifications (GPS) -- Dimensional tolerancing -- Part 2: Dimensions other than linear sizes
ISO 14801:2007 Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants
ISO 14937:2009 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971:2007 Medical devices -- Application of risk management to medical devices
ISO 17664:2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices
ISO 17665-1:2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 1942:2009 Dentistry -- Vocabulary
ISO 7405:2008 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry
ISO 8601:2004 Data elements and interchange formats -- Information interchange -- Representation of dates and times
ISO/TS 11135-2:2008 Sterilization of health care products -- Ethylene oxide -- Part 2: Guidance on the application of ISO 11135-1
ISO/TS 22911:2005 Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods

Tekninen komitea

CEN/TC 55 Dentistry »

Direktiivi

93/42/EEC Lääkinnälliset laitteet

http://ec.europa.eu »

Vahvistuspäivä

06.09.2010

Julkaisupäivä

24.09.2010

Painos

2

Sivumäärä

12

Julkaisun kieli

englanti