Standard Svensk standard · SS-EN 556-2:2015

Sterilisering av medicintekniska produkter - Krav för märkning med symbolen "STERILE" - Del 2: Krav på aseptiskt tillverkade medicintekniska produkter

Status: Gällande

Omfattning
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.

Ämnesområden

Sterilisering och desinficering allmänt


Produktinformation

Språk: Engelska

Framtagen av: Rengöring, desinfektion och sterilisering, SIS/TK 349

Internationell titel: Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

Artikelnummer: STD-8015813

Utgåva: 2

Fastställd: 2015-09-09

Antal sidor: 28

Ersätter: SS-EN 556-2:2004