Standard Svensk standard · SS-EN ISO 11607-2:2020

Förpackningar för medicinsktekniska produkter som skall steriliseras - Del 2: Valideringskrav på processer för formning, försegling och hopsättning (ISO 11607-2:2019)

Status: Gällande

Omfattning
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

Ämnesområden

Sterilisering vid förpackning (11.080.30)


Produktinformation

Språk: Engelska

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

Internationell titel: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

Artikelnummer: STD-80019290

Utgåva: 3

Fastställd: 2020-01-20

Antal sidor: 24

Ersätter: SS-EN ISO 11607-2:2006 , SS-EN ISO 11607-2:2006/A1:2014 , SS-EN ISO 11607-2:2018