Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Search research articles

Related Experiment Videos

The ISO 11607 Revisions.

¹DDL Inc., Eden Prairie, Minnesota 55344, USA. pat.nolan@testedandproven.com

Medical Device Technology

|December 13, 2006

Summary

This summary is machine-generated.

Manufacturers and package engineers face challenges with ISO 11607 revisions for sterile medical device packaging. This review addresses key questions regarding validation under the new standards.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same author

Nitrate-Stimulated Release of Naturally Occurring Sedimentary Uranium.

Environmental science & technology·2023

Same author

Uranium(VI) attenuation in a carbonate-bearing oxic alluvial aquifer.

Journal of hazardous materials·2021

Same author

Assessing CZT detector performance for environmental radioactivity investigations.

Radiation protection dosimetry·2012

Same author

Potential health risks from radioactive contamination of saltmarshes in NW England.

Journal of environmental radioactivity·2011

Same author

Return of collective rotation in 157Er and 158Er at ultrahigh spin.

Physical review letters·2007

Same author

High-spin structure beyond band termination in 157Er.

Physical review letters·2004

Same journal

Safer arterial access.

Medical device technology·2010

Same journal

Building better surfaces.

Medical device technology·2010

Same journal

PVC: a broader perspective.

Medical device technology·2010

Same journal

Joining and forming using torsional ultrasonic principles.

Medical device technology·2010

Same journal

US regulation of combination products.

Medical device technology·2010

Same journal

Assessing biological safety of metals associated with medical devices.

Medical device technology·2010

See all related articles

Area of Science:

Medical Device Packaging
Sterilization Validation
Regulatory Compliance

Background:

Recent revisions to ISO 11607 necessitate updated validation strategies for terminally sterilized medical device packaging.
Manufacturers and package engineers require clear guidance on meeting new regulatory requirements.

Purpose of the Study:

To address common questions arising from webinars concerning ISO 11607 revisions.
To provide clarity on packaging validation for terminally sterilized medical devices under new standards.

Main Methods:

Review of frequently asked questions from industry professionals.
Analysis of specific concerns related to ISO 11607 compliance.

Main Results:

Related Experiment Videos

Identified key areas of confusion regarding packaging validation requirements.

Provided answers to critical questions impacting manufacturers and package engineers.

Conclusions:

Understanding and implementing the revised ISO 11607 standards is crucial for ensuring sterile medical device packaging integrity.
Proactive engagement with validation requirements minimizes risks and facilitates compliance.