EN ISO 11607-1:2017 pdf download.Packaging for terminally sterilized medical devices — Requirements for materials, sterile barrier systems and packaging systems
1 Scope
2 Normative references
Paper and board — Determination of air permeance and air resistance (medium range) —Part 5: Gurley method
3 Terms and definitions
3.1 aseptic presentation
3.2 bioburden
3.7 medical device
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— investigation, replacement, modification or support of the anatomy or of a physiological process,
— supporting or sustaining life,
— control of conception,
— disinfection of medical devices,
— providing information for medical purposes by means of in vitro examination of specimens derived
4.4 Test methods
— establishment of a rationale for the selection of the appropriate tests for the packaging system;
— establishment of acceptance criteria;
— determination of test method repeatability;
— determination of test method reproducibility; and
— establishment of test method sensitivity for integrity tests.
EN ISO 11607-1:2017 pdf download
