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Glavni meni

ISO 10993-7:2008

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
13. 10. 2008.

Опште информације

90.92     16. 3. 2022.

ISO

ISO/TC 194

Međunarodni standard

11.100.20  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.

Životni ciklus

PRETHODNO

POVUČEN
ISO 10993-7:1995

TRENUTNO

OBJAVLJEN
ISO 10993-7:2008
90.92 Odluka o izmeni ili reviziji standarda
16. 3. 2022.

ISPRAVKE / IZMENE

OBJAVLJEN
ISO 10993-7:2008/Cor 1:2009

OBJAVLJEN
ISO 10993-7:2008/Amd 1:2019

REVIDIRAN OD

PROJEKAT
ISO/FDIS 10993-7