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ISO 10993-1:2009

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
13. 10. 2009.
95.99   Povučen   17. 8. 2018.

Опште информације

95.99     17. 8. 2018.

ISO

ISO/TC 194

Međunarodni standard

11.100.20  

engleski   francuski  

Kupovina

Povučen

Jezik na kome želite da primite dokument.

Apstrakt

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.


Životni ciklus

PRETHODNO

POVUČEN
ISO 10993-1:2003

TRENUTNO

POVUČEN
ISO 10993-1:2009
95.99 Povučen
17. 8. 2018.

ISPRAVKE / IZMENE

POVUČEN
ISO 10993-1:2009/Cor 1:2010

REVIDIRAN OD

OBJAVLJEN
ISO 10993-1:2018