SK EN ISO 14937:2017

Status: Published
Gjuha: English
Faqe: 45
Publikuar: 2017-12-01
Regjistri Kombëtar: 213/2017
Botim:

Standardet ndërkombëtare që kanë lidhje

This standard is identical to:
EN ISO 14937:2009
CEN/TC 204

This standard is identical to:
ISO 14937:2009
ISO/TC 198

Çmim: 34 €

Titulli Shqip

Sterilizatorët për produkte për kujdesin e shëndetit -Kërkesa të përgjithshme për tipizimin e një agjenti sterilizues dhe zhvillimin, vlerësimin dhe kontrollin rutinë të një procesi sterilizues për pajisjet mjekësore

Titulli Anglisht

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

Scope Shqip

Asnjë informacion i shtuar.

Scope Anglisht

ISO 14937:2009 specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. It applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means and is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices. ISO 14937:2009 specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process.