Updates have been made to the following IEC industry standard:

IEC 60601-1-8 Ed. 2.0 (2006-10) Preview Price: CHF 237.00
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Read about the updated IEC 60601 standard.

ISO 11607, the foremost guidance document for validating packaging for terminally sterilized medical devices, has been revised.  The new ISO 11607-01 standard contains new compliance requirements for medical device manufacturers and package engineers.

Clause 6 is the most affected part of the standard.  This is the clause that addressses the package’s ability to deliver a medical device to the patient without jeopardizing sterility or incurring defect.  An entire section has been added to Clause 6 to address the requirements for sterile fluid pathways.

The revisions to ISO 11607 also affect the following:

• Test Methods
• Sampling Plans