Packaging systems for terminally sterilized medical devices must meet strict performance requirements to ensure they protect the enclosed device from contamination and damage, enabling it to be used safely. These requirements are outlined in the internationally recognized ISO 11607 standard series, which consists of the following parts:
ISO 11607-1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2: Validation requirements for forming, sealing and assembly processes
These are both FDA-recognized consensus standards and harmonized standards under the EU Medical Device Regulation (MDR), making ISO 11607 the recommended framework for assessing medical device packaging safety and performance in the US and the EU.
Some of the key requirements of ISO 11607-1 and ISO 11607-2 for packaging design and performance testing are summarized below. Still, developing and validating a suitable packaging system is always a case-by-case process that needs to account for various factors, from the medical device’s intended use to the sterilization method and storage conditions. If you have further questions about the topic or need testing to validate your packaging system, our experts are happy to help.
Medical device packaging configuration under ISO 11607
According to ISO 11607, the packaging system for terminally sterile medical devices shall consist of the following parts:
A sterile barrier system (SBS), which provides an adequate microbial barrier to allow the device to be sterilized and remain sterile until removed from the packaging.
Protective packaging, which protects the sterile barrier system from damage induced by external conditions, such as mechanical or thermal stress.
There are various forms of SBS, with examples including rigid trays with die-cut lids, flexible peel pouches, sterilization bags, header bags, form/fill/seal (FFS) systems, and four-side-sealing (4SS) configurations. When the SBS is supplied to a healthcare facility in a partially assembled form for filling and closure, it is known as a preformed sterile barrier system. These tend to come in the form of pouches, bags, and reusable rigid containers.
Protective packaging may consist of more conventional materials, such as corrugated cardboard, but it may also outwardly resemble sterile packaging. In these cases, it is important to label the packaging system clearly so that the user can differentiate between the validated SBS and the protective packaging.
Key properties of medical device packaging
A packaging system compliant with ISO 11607 must protect the device from microbial and chemical contamination, as well as damage caused by environmental, processing, and use conditions. It must also be labeled accurately to prevent the use of expired or incorrect devices. To ensure these criteria are met, the following key properties must be evaluated:
Microbial barrier – The SBS must prevent microorganisms from reaching the device. In the case of impermeable materials, this is shown through air permeance testing, while porous materials are tested for their ability to block bacterial spores.
Chemical properties – Packaging materials must meet established chemical specifications (e.g. pH value, sulfate content) and must not release toxic substances in quantities that would pose a biocompatibility hazard.
Physical properties – The material must not have holes, cracks, or other defects, and it must meet established mechanical performance specifications (e.g. tensile strength, tear resistance, and burst strength).
Compatibility with the sterilization process – It must be possible to sterilize the device within the SBS without excessive sterilization residues (e.g. ethylene oxide) remaining on the device.
Stability over time – The above properties must remain within acceptable limits throughout the intended shelf life. The influence of environmental factors, such as temperature, pressure, humidity, and exposure to sunlight or UV light, must be accounted for during stability testing.
Additional requirements apply to specific types of sterile packaging, such as reusable containers, which must be labeled with information on the maximum number of reuses. Closure systems must also be validated, ensuring sufficient seal strength or other form of continuous closure that is not compromised until opened at the point of use.
Standardized test methods for ISO 11607 compliance testing
Standardized test methods to evaluate conformity with the above requirements are listed in Annex B to ISO 11607-1. The non-exhaustive list contains over 100 methods from several standardization organizations, including ISO, CEN, ASTM, and TAPPI. Other methods can also be used, as long as the rationale for test selection and acceptance criteria are duly justified.
The following are examples of commonly applied test methods for ISO 11607 compliance testing:
EN 868: Requirements and test methods for packaging for terminally sterile medical devices. The standard series consists of nine parts (2–10), laying down the specifications for different types of packaging, including sterilization wrap (Part 2), paper bags (Part 4), sealable pouches (Part 5), and reusable containers (Part 8).
ASTM F1608: Microbial ranking of porous packaging materials. This standard is very often followed to evaluate microbial barrier properties.
ASTM F1980: Accelerated aging of sterile barrier systems. The standard is used to formulate an appropriate accelerated aging protocol that can be used when evaluating the effects of time on the integrity of the sterile barrier system.
ASTM D4169: Performance testing of shipping containers. This standard is followed to evaluate the effectiveness of the outer packaging in protecting the SBS from stresses encountered during transportation.
Measurlabs offers these and various additional tests to evaluate medical device packaging performance. Our experts are happy to provide a custom quote for validating your packaging system, so do not hesitate to contact us using the form below.