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SSH EN ISO 10993-7:2008

Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 7: Mbetjet e sterilizimit të oksidit të etilenit (ISO 10993-7:2008)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
26 mar 2012

General information

60.60     26 mar 2012

DPS

DPS/KT 316

European Norm

11.100.20  

anglisht  

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Scope

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.

Related directives

Directives related to this standards.

90/385/EEC

Pajisjet mjekësore aktive transplatuese

Të harmonizuara
93/42/EEC

Pajisje Mjekësore

Të harmonizuara

Life cycle

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PUBLISHED
SSH EN ISO 10993-7:2008
60.60 Standard published
26 mar 2012

Related project

Adopted from EN ISO 10993-7:2008