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ISO 11607 Changes
DDL has launched a service that e-mails alerts on standards changes. Professionals who sign up on DDL’s Web site can request updates on specific standards or from designated associations. Standards bodies covered include ASTM, ISO, AAMI, and IEC.
PMP News editors recently toured DDL West (Costa Mesa, CA), taking in its full-service lab for strength and integrity testing as well as aging and distribution simulation. Karen Greene, technical director, told PMP News that the newly revised ISO 11607-1 and 11607-2:2006 more clearly define stability testing (e.g., accelerated aging and real-time aging) and performance testing (e.g., environmental and distribution testing) as separate entities, evaluating different aspects of the sterile barrier package.
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Complying with EU Packaging Regulations Using ASTM International Standards
The world would be chaotic were it not for standards that allow the industrial community to simplify commerce. Standards promulgate a common language that promotes the flow of goods between buyer and seller and aids the common man by improving safety and safeguarding health. Some simple examples are; the use of nuts and bolts in both the metric or SI systems; a 92 octane gasoline that meets specific combustion ‘standards’ and state and federal regulations require that gasoline meet these standards so the consumer knows what he/she is pumping into their gas tanks; plugs (e.g. serial, parallel, RF) for connecting peripheral components to computers are all uniform worldwide for every type, make, and manufacturer of computers; medical devices are tested using standardized test methods so that performance specifications can be developed, and these same tests can be used to test the efficacy of similar or competing devices. Standards create order where there is disorder.
In short, “buildings stand, planes fly, paint adheres, chairs support, and clothes fit because each is made to order by technical standards for materials, design, and performance”. |
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DDL Responds to Increased Demand for Medical Device Product Testing
DDL Inc. testing services, a MN-based package, product & material testing laboratory, is responding to the needs of medical device manufacturers by expanding both its product test engineering team and its laboratory equipment inventory. The MN-based testing facility has grown its test engineering team with additional technicians and test engineers in order to replicate the dynamic and environmental hazards inherent in medical device transportation and daily operational environments. Information: www.testedandproven.com
Medical Design Technology |
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Treat the Packaging as an Accessory
Packaging for medical devices play a key role in safely delivering specialized treatment to patients. Most single-use, sterilized medical devices can be opened with a high degree of confidence that it has remained sterile throughout storage, handling, and transportation.
What makes packaging doubly important is that regulatory authorities recognize the critical nature of sterile barrier or primary package by considering them components or accessories to the medical device. This implies that packaging is almost as important as the device itself. And it is. If a package does not keep, for instance, a pacemaker sterile, patients will be put at risk.
The design and development of packaging has rightfully come under closer scrutiny by international and domestic regulatory agencies. This scrutiny has placed a great deal of emphasis on standardizing package development. Some standardization comes in the form of the international standard ISO 11607: Packaging for terminally sterilized medical devices. |
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Medical-package testing firm plans expansion to coast
Ddl Inc., which tests packaging for medical device products, plans to expand to the East Coast by the end of this year. The Eden Prairie-based firm, which has two testing laboratories in Minnesota and one in Southern California, is scheduled to move one of its sales representatives to Boston and hopes to start building a facility next year. |
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Web Sightings
A package, product, and material testing lab has designed its Web site to be an interactive resource to keep manufacturers and packaging professionals up to date with changing compliance requirements for the industry. Along with articles and information about the company’s services, users can access the company’s free PackReview start-up kit offered to manufacturers that want to validate their packaging in compliance with ISO 11607. |
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Packaging Validation Sessions at MD&M Minneapolis
The Medical Design & Manufacturing (MD&M) Minneapolis event will feature special sessions on medical device pack-aging with Douglas Stockdale of Stockdale Associates Inc. as chairperson. The first session will focus on packaging engineering and will include an overview of ISO 11607 revisions with special attention on the standard’s Clause 6, as well as utilizing packaging design software and equipment considerations for tray sealing. The second session will focus on packaging validation and compliance. This session will cover sterile barrier system validation and expiration dating considerations, form-fill-seal packaging equipment qualifications, distributions and shipping validation, and appropriate sample sizes for packaging testing requirements. The event will be held October 24–26. It is presented by Canon Communications (Los Angeles), the publisher of PMP News.
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ISO 11607 Revisoins Webinar from DDL Describes Changing Requirements for Distribution of Medical Devices
Minneapolis, MN – http://www.testedandproven.com/webinars.html - DDL, a leading medical device package testing laboratory, is hosting the second of three free webinars on the upcoming revisions to the ISO 11607 standard – “Packaging for Terminally Sterilized Medical Devices.”
The second ISO 11607 Revisions webinar from DDL, “Understanding Clause 6,” delves into clause 6 of the standard which focuses on a package’s ability to deliver a medical device to the patient without jeopardizing sterility or incurring defect.
“Safe and sterile distribution of a medical device to the end-user is critical,” said Patrick Nolan, COO of DDL. “Changes to ISO 11607 Clause 6 are intended to improve this process, but industry pro’s that do not understand compliance changes may find that their package or product fails when it comes to the testing lab.”
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Common Mistakes in Validating Package Systems
Some common pitfalls can occur during package development and validation. Here’s how to avoid them.
Patrick Nolan
A medical device’s package plays a key role in safely delivering treatment to patients. It must ensure the integrity of the device from the point of manufacture to the point of final use. In addition, packaging often has a direct function in the application of the treatment; for example, it may act as a fixture or a dispenser. Therefore, mechanical damage to a package cannot be tolerated. Device components and packaging systems must combine to create a product that performs efficiently, safely, and effectively in the hands of the user.
The packaging process is extremely important as well. Regulatory authorities recognize the critical nature of a sterile barrier system. In fact, they consider packaging an accessory or a component of the medical device, which implies that the package system is nearly as important as the device itself. The package must keep a device sterile throughout all the stresses and hazards generated by the manufacturing, shipping, and storage environments. Ultimately, any device that is labeled as sterile but arrives nonsterile at the point of use can critically compromise patient safety.
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ISO 11607 Revisions Webinar from DDL Describes Changing Requirements for Distribution of Medical Devices
Minneapolis, MN – http://www.testedandproven.com/webinars.html - DDL, a leading medical device package testing laboratory, is hosting the second of three free webinars on the upcoming revisions to the ISO 11607 standard – “Packaging for Terminally Sterilized Medical Devices.”
The second ISO 11607 Revisions webinar from DDL, “Understanding Clause 6,” delves into clause 6 of the standard which focuses on a package’s ability to deliver a medical device to the patient without jeopardizing sterility or incurring defect.
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Click here for complete article.
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