If you have experience as a medical device packaging professional, then you are perfectly familiar with the International Standards Organization (ISO). The ISO is “an independent, non-governmental international organization… [that] brings experts together to develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.” According to the ISO, standards are so important because they “make things work.”
ISO 11607, Parts 1 and 2, have played a major role in the medical packaging realm for about two decades. ISO 11607 has guided medical packaging development with standards that outline requirements for packaging materials and sterile barrier package systems. This includes physical, barrier, chemical, biocompatibility, and toxicology attributes for materials and even performance testing for package systems. In other words, ISO 11607 specifies the requirements and test methods that ensure medical products are safe for consumers.
Now ISO 10993-18 must be taken into consideration as well. As explained by Wei Zhang, Ph.D, senior research scientist, “The biological safety attributes of medical devices are regulated by the ISO 10993 series, which cover a broad scope of safety evaluations through a variety of means including in-vitro and in-ivo biological evaluations, chemical characterization, and risk assessments. Since case packer packaging materials that contact a medical device can transfer chemical constituents to the device, followed by an indirect exposure to the patient or user, the potential for introduction of contaminants from packaging materials should be considered.”
The revisions to ISO 10993-18 will provide the framework for chemical characterization in order to address important regulatory questions surrounding tray forming. Given the essential nature of consumer safety when it comes to medical device packaging, every standard provided and revised by the ISO must be thoroughly adopted into common practices.