ISO Packaging Standard Revised
Thomas McMahon
Guide to Medical Device Regulation
Article Summary
The International Organization for Standardization (ISO) has its international standard on Device Packaginging (ISO 11607) to incorporate provisions of the British Standard (BS) and European Norm (EN) standards BS/EN 868-1, dealing with packaging materials and systems to maintain device sterility until the point of use.
“Harmoniz[ation]…has been the goal of the ISO and European Committee for standardization ever since development of these standards was initiated,” said Patrick J. Nolan, chief operating officer of DDL, Inc., a package, product, and material testing laboratory with offices in Minnesota and California.
