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 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.
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.
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?
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.
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).
Speakers at the upcoming HealthPack event March 6-8 in Albuquerque will update attendees on industry-specific AAMI, ISO, ASTM, and ISTA standards.
We hear a lot these days about sunrise dates in the global GS1 System of product identification and related supply-chain standards. A sunrise date is a date in the future, agreed to and typically announced years in advance, at which point an industry or market sector is expected to be prepared to implement a specific technology.