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Norm

ISO 10993-1:2009

Ausgabedatum: 2009 10 13

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of...
Weiterlesen
ZURÜCKGEZOGEN : 2018 08 17
Herausgeber:
International Organization for Standardization
Format:
Digital | 21 Seiten
Sprache:
Englisch
Aktuell Gültig:
ISO 10993-1:2018:2018 08 17
ICS
11.100.20
Fachgebiete
Healthcare, Laboratory medicine, Biological evaluation of medical devices

ISO 10993-1:2009 describes:

  • the general principles governing the biological evaluation of medical devices within a risk management process;
  • the general categorization of devices based on the nature and duration of their contact with the body;
  • the evaluation of existing relevant data from all sources;
  • the identification of gaps in the available data set on the basis of a risk analysis;
  • the identification of additional data sets necessary to analyse the biological safety of the medical device;
  • the assessment of the biological safety of the medical device.
ISO 10993-1:2018
2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management p...
Norm
ISO 10993-1:2009
2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management p...
Norm
↖
ISO 10993-1:2003
2003 07 28
Biological evaluation of medical devices — Part 1: Evaluation and testing
Norm
ISO 10993-1:1997
1997 12 11
Biological evaluation of medical devices — Part 1: Evaluation and testing
Norm
ISO 10993-1:1992/Cor 1:1992
1992 09 09
Biological evaluation of medical devices — Part 1: Guidance on selection of tests — Technical Corrig...
Norm
ISO 10993-1:1992
1992 04 23
Biological evaluation of medical devices — Part 1: Guidance on selection of tests
Norm
Historie aufklappen
Norm
ISO 10993-1:2018
Ausgabedatum : 2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)