Standards

Former Kaiser Permanente Program Director Joins GS1 US to Lead Healthcare Standards Effort

Michael Innes has joined GS1 to serve as vice president, healthcare, where he will head GS1 Healthcare US. The initiative promotes the adoption of open, global standards to help healthcare companies improve accuracy, speed and efficiency in their supply chain and care delivery, GS1 reports.

5 Tasks for Implementing ISO 13485

In a recent blog post on Medical Device Academy, Brigid Glass shares "12 Important Tasks for Implementing ISO 13485."

I've listed five of her twelve tasks to include into your plan.

IEC 60601-1-3: Identify Essential Performance of a Medical Device

The difference between IEC 60601-1 edition 2 and edition 3 is that clause 4.3 of IEC 60601-1 requires the manufacturer to identify essential performance by applying risk management. Essential performance is defined as performance necessary to achieve freedom from unacceptable risk. Essential performance is most easily understood by considering whether its absence or degradation.

ASTM D7611: The Möbius Loop Versus an Equilateral Triangle

ASTM International has published a brochure (purchase required) that proudly states, "ASTM D7611 now uses a solid equilateral triangle symbol surrounding a numeral from 1 to 7 that defines the resin type used in the product's packaging." The brochure shows you the revised symbols.

European Harmonized Standards: Beware of Annex ZA!

The three EU directives for medical devices: MDD1, AIMDD2, and IVDD3, follow the concept defined as the "New Approach4" which was introduced in the 90s.

How Do I Know What Test Method to Use? ASTM F2097 Can Help

What test methods should I be using to qualify my materials or test my package? What are some development tools to select a new material? With several test methods available for a specific property, which one should I use?

Upcoming Revisions of EN ISO 11607 & New Guidance

At the two-day conference on Medical Packaging for Patient Safety and Health Care Effectiveness held in Helsinki, every speaker mentioned at least once what has become the absolute industry standard: EN ISO 11607.

Designing Medical Device Packaging for Sustainability

The primary interest for medical packaging engineers is to ensure the integrity of a sterile barrier over the duration of the expiry dating. Secondarily, due to regional and country regulations, sustainability is becoming an increasingly important issue. With that in mind, International Safe Transit Associations (ISTA) recently developed a new guideline for sustainability called Responsible Packaging by Design (RPbD), which was vetted by industry and NGO representatives (including INCPEN and EUROPEAN).

HealthPack to Feature Expanded Standards Update

Speakers at the upcoming HealthPack event March 6-8 in Albuquerque will update attendees on industry-specific AAMI, ISO, ASTM, and ISTA standards.

Perfecseal Facility Certified To Class 7 Cleanroom Standards

 
Perfecseal has certified its Oshkosh, WI sterile medical pouch and bag manufacturing facility to ISO 14644-1 (1999) Class 7 cleanroom standards.
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