Bundled permeation units

Compliance responsibilities that were clearly outlined in section 4.4 of the current standard have been omitted from the new International Standards Organization (ISO) 11607-01. Therefore, confusion may arise over certain areas of responsibility such as: • Who should test the packaging suppliers' seals? • Who is responsible for validating package sealing equipment? • Who is responsible for evaluating the biocompatibility or other material characteristics such as microbial barrier properties?