SRPS EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

Scope

This standard specifies the requirements and test methods for packaging materials and final packages (systems) that are intended to maintain sterility of the terminally sterilized medical devices to the point of use. This standard is applicable to industry, health care facilities, and whererver sterilized medical devices are packed and sterilized.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.