ThomasNet News Logo
Sign Up | Log In | ThomasNet Home | Promote Your Business

ASTM Standard helps determine endovascular device shelf life.

Print | 
Email |  Comment   Share  
August 2, 2012 - ASTM F2914, Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices, was developed by Subcommittee F04.30 on Cardiovascular Standards, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices. Standard will enable companies to use engineering testing or fundamental engineering principles to justify whether certain attributes are unaffected by age and whether they need to be tested after aging.

New ASTM Medical Standard Provides Methodology to Determine Endovascular Device Shelf Life


(Archive News Story - Products mentioned in this Archive News Story may or may not be available from the manufacturer.)

ASTM International
100 Barr Harbor Dr., Box C700
West Conshohocken, PA, 19428-2959
USA



Press release date: July 27, 2012

W. CONSHOHOCKEN, Pa., -A new ASTM International standard provides a much-needed methodology for determining the shelf life of various attributes of endovascular devices.

The new standard, ASTM F2914, Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices, was developed by Subcommittee F04.30 on Cardiovascular Standards, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.

According to Benjamin Gundale, manager, research and development, Boston Scientific, lack of standardization has complicated the process of shelf life testing.

"Different companies do this process differently and different regulatory agencies treat the topic differently," says Gundale, a member of F04.30. "This makes the process of getting products approved unpredictable and more expensive than necessary. Standardizing the process for determining which attributes are tested in shelf life will enable manufacturers to have a more direct path to get approved and yet provides flexibility for companies to do what makes sense."

Gundale notes that the new standard will enable companies to use engineering testing or fundamental engineering principles to justify whether certain attributes are unaffected by age and whether they need to be tested after aging.

"The application of ASTM F2914 can drive the cost of validation down and enable our medical devices to be more affordable to patients and our society," says Gundale. "This is especially important given our healthcare environment with the need to drive medical costs down while maintaining patient care quality. Finally, ASTM F2914 can help give regulatory reviewers a road map for how to review a company's justification."

Interested parties are welcome to join in the activities of F04.30. The subcommittee plans on expanding the focus of ASTM F2914 in future revisions and would like the input of people who do shelf life studies and who may have knowledge about aspects that have not been well defined in recent publications.

To purchase ASTM standards, visit www.astm.org and search by the standard designation, or contact ASTM Customer Relations (phone: 877-909-ASTM; sales@astm.org). ASTM International welcomes participation in the development of its standards. For more information on becoming an ASTM member, visit www.astm.org/JOIN. ASTM International is one of the largest international standards development and delivery systems in the world. ASTM International meets the World Trade Organization (WTO) principles for the development of international standards: coherence, consensus, development dimension, effectiveness, impartiality, openness, relevance and transparency. ASTM standards are accepted and used in research and development, product testing, quality systems and commercial transactions.

For more news in this sector, visit www.astm.org/sn-medical or follow us on Twitter @ASTMMedical.

ASTM Committee F04 Next Meeting: Nov. 13-16, 2012, November Committee Week, Atlanta, Ga.
Technical Contact: Benjamin Gundale, Boston Scientific, Maple Grove, Minn., Phone: 763-494-2771; gundaleb@bsci.com
ASTM Staff Contact: Pat Picariello, Phone: 610-832-9720; ppicarie@astm.org
ASTM PR Contact: Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org
Print | 
Email |  Comment   Share  
Contacts: View detailed contact information.


 

Post a comment about this story

Name:
E-mail:
(your e-mail address will not be posted)
Comment title:
Comment:
To submit comment, enter the security code shown below and press 'Post Comment'.
 



 See related product stories
More .....
 See more product news in:
Services
 More New Product News from this company:
ASTM Workshop to address additives in biomedical polymers.
Oil Training Course examines sampling, testing, evaluation.
Radiant Barrier Systems Standards approved by ASTM committee.
Training Course addresses hazards in oxygen systems.
More ....
| Featured Manufacturing Jobs
 Other News from this company:
ASTM/NIBS Workshop on Building Science Education in North America
Fatigue and Fracture of Metallic Medical Materials and Devices
ASTM International Compilation on Silica and Associated Respirable Mineral Particles
Guidance for Potential Solar Photovoltaic Investors to Be Provided in Proposed ASTM Standard
Test for Sustained Air Performance of Central Vacuum Cleaning Units Approved as ASTM Standard
More ....
 Tools for you
Watch Company 
View Company Profile
Company web site
More news from this company
E-mail this story to a friend
Save Story
Search for suppliers of
Trade Associations


Home  |  My ThomasNet News®  |  Industry Market Trends®  |  Submit Release  |  Advertise  |  Contact News  |  About Us
Brought to you by Thomasnet.com        Browse ThomasNet Directory

Copyright © 2014 Thomas Publishing Company. All Rights Reserved.
Terms of Use - Privacy Policy



Error close

Please enter a valid email address