Standard Svensk standard · SS-EN ISO 10993-7:2008

Biologisk värdering av medicintekniska produkter - Del 7: Rester från sterilisering med etylenoxid (ISO 10993-7:2008)

Status: Gällande · Korrigeras av: SS-EN ISO 10993-7:2008/AC:2009

Omfattning
This part of ISO 10993 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 this document is applied, are also included in the informative annexes.

EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993.

NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).

Ämnesområden

Biologisk värdering av medicintekniska produkter (11.100.20)


Produktinformation

Språk: Engelska

Framtagen av: Biologisk säkerhet, SIS/TK 340/AG 02

Internationell titel:

Artikelnummer: STD-67658

Utgåva: 2

Fastställd: 2008-10-20

Antal sidor: 104

Ersätter: SS-EN ISO 10993-7