0 Stavka
Moj nalog
Telefon: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Prodaja standarda: prodaja@iss.rs Seminari, obuke: iss-edukacija@iss.rs Informacije o standardima: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Glavni meni

ISO 10993-1:2003

Biological evaluation of medical devices — Part 1: Evaluation and testing
28. 7. 2003.
95.99   Povučen   13. 10. 2009.

Опште информације

95.99     13. 10. 2009.

ISO

ISO/TC 194

Međunarodni standard

11.100.20  

engleski  

Kupovina

Povučen

Jezik na kome želite da primite dokument.

Apstrakt

ISO 10993-1:2003 describes
the general principles governing the biological evaluation of medical devices;the categorization of devices based on the nature and duration of their contact with the body;the selection of appropriate tests.
It does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure.
Other parts of ISO 10993 cover specific tests.

Životni ciklus

PRETHODNO

POVUČEN
ISO 10993-1:1997

TRENUTNO

POVUČEN
ISO 10993-1:2003
95.99 Povučen
13. 10. 2009.

REVIDIRAN OD

POVUČEN
ISO 10993-1:2009

Nacionalna preuzimanja

SRPS EN ISO 10993-1:2008  
ISS

Biološko vrednovanje medicinskih sredstava - Deo 1: Vrednovanje i ispitivanje

95.99   Povučen

Z076 Saznaj više