Informējam, ka Sistēma pielāgota darbam ar interneta pārlūkprogrammu Internet Explorer (8. un jaunākām versijām) un Mozilla Firefox (3.6 un jaunākām versijām).
Izmantojot citu interneta pārlūkprogrammu, brīdinām, ka Sistēmas funkcionalitāte var tikt traucēta.
<p><span lang="EN-GB">This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies.</span></p>
<p><span lang="EN-GB">This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring.</span></p>
<p><span lang="EN-GB">This document applies to both preformed sterile barrier systems and sterile barrier systems.</span></p>
<p><span lang="EN-GB">This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management.</span></p>
<p><span lang="EN-GB">This document is intended to be used prior to process validation.</span></p>
<p><span lang="EN-GB">NOTE ISO 11607-2 provides requirements for process specification and process validation.</span></p>
Reģistrācijas numurs (WIID)
87167
Darbības sfēra
<p><span lang="EN-GB">This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies.</span></p>
<p><span lang="EN-GB">This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring.</span></p>
<p><span lang="EN-GB">This document applies to both preformed sterile barrier systems and sterile barrier systems.</span></p>
<p><span lang="EN-GB">This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management.</span></p>
<p><span lang="EN-GB">This document is intended to be used prior to process validation.</span></p>
<p><span lang="EN-GB">NOTE ISO 11607-2 provides requirements for process specification and process validation.</span></p>
