What is the ISO standard for implantable medical device labeling requirements?
Healthcare technology is advancing at a lightning fast pace, revealing new possibilities to treat and cure disease and injury, lengthen life expectancy, reduce suffering, and generally improve people’s quality of life. But those benefits depend on stringent safety standards that ensure new products are safe and effective. Regulations guiding labeling practices for medical devices, particularly those that are implanted, are no exception. But what’s the ISO standard for implantable medical device labeling requirements?
Labeling requirements for implantable medical devices
Regulatory bodies such as the US Food and Drug Administration (FDA) and the European Commission require specific labeling elements to ensure that essential device information is clearly communicated, reducing risks associated with improper use, storage, or handling. Standards set by the International Organization for Standardization provide companies with concrete guidelines to help them meet these global regulations.
Read on to learn which ISO standards apply directly to implantable medical devices, and how they relate to label features such as durability, sterility, and adhesion.
ISO standards for medical device labels
Five sets of ISO standards, in particular, provide detailed guidance on medical device labeling requirements: ISO 15223-1, ISO 15223-2, ISO 11607-1, ISO 10993-1, and ISO 20417. All four play a critical role in ensuring essential medical device information is conveyed clearly and safely.
ISO 15223-1 and ISO 15223-2
ISO 15223-1 specifies the symbols and information required on medical device labels to improve clarity and minimize language barriers, particularly in international contexts. This standard covers symbols that convey essential details like sterilization status, expiry dates, and handling precautions, helping healthcare professionals quickly interpret device information.
ISO 15223-2 complements ISO 15223-1 by providing guidance on validating these symbols, ensuring they are easily understood across different regions and languages. This verification process is essential for preventing misunderstandings in critical healthcare environments.
ISO 11607-1
ISO 11607-1 addresses the packaging requirements for terminally sterilized medical devices. It establishes the standards for packaging systems to maintain sterility and protect device integrity. Labeling under ISO 11607-1 must meet label durability requirements to ensure that information remains legible and adhered to packaging throughout handling and storage.
ISO 20417
ISO 20417 consolidates labeling requirements for medical devices, offering a comprehensive framework that supports compliance with multiple regulatory demands. It covers crucial elements such as unique device identification (UDI), required contact information, and any warnings or precautions necessary for safe use.
ISO 10993-1
ISO 10993-1 impacts medical device labeling by setting biocompatibility standards to ensure materials are safe for human contact. This standard guides the selection of label materials, including adhesives, inks, and coatings, to prevent harmful reactions in patients or within sterile environments.
What is unique device identification (UDI)?
Unique Device Identification (UDI) is a concept found in both ISO labeling standards and broader global regulations. It plays a crucial role in the labeling of implantable medical devices by providing a standardized system to identify and track each device throughout its lifecycle.
Each UDI is a unique code consisting of two parts:
- A device identifier (DI), which is specific to the device model
- A production identifier (PI), which includes information such as batch number, serial number, and expiration date.
This unique coding allows healthcare professionals and regulators to accurately trace devices back to the manufacturer and production details, which is essential in cases of adverse events or device recalls.
Unique device identification (UDI) labeling compliance
ISO standards, particularly ISO 15223-1 and ISO 20417, align closely with global UDI requirements, supporting manufacturers in meeting the expectations set by major regulatory bodies. Here’s a quick summary of how each of the ISO standards above impacts UDI.
- ISO 15223-1: Establishes the use of standardized symbols, including those for UDI, to communicate essential device information clearly on labels.
- ISO 15223-2: Provides guidelines for verifying that symbols, such as those related to UDI, are universally understandable to support consistent labeling.
- ISO 11607-1: Addresses packaging requirements, ensuring that UDI labels remain intact and legible to maintain traceability through sterilization and storage.
- ISO 10993-1: Focuses on biocompatibility, indirectly impacting UDI by ensuring label materials do not compromise patient safety when used on or with implantable devices.
- ISO 20417: Defines comprehensive labeling requirements, mandating the inclusion of UDI to enhance traceability and compliance across global markets.
ISO label and packaging material requirements for implantable medical devices
Because implantable medical devices are in direct contact with the human body, the ISO requirements for materials used to package and label them is incredibly strict.
Biocompatibility
ISO 10993-1 mandates that materials used in medical devices, such as adhesives, inks, and coatings, be evaluated for potential biological risks, when they have direct or indirect contact with bodily tissues or fluids. It underscores the importance of ensuring these materials are non-toxic, non-reactive, and biocompatible. For implantable medical device labels, any material with potential for direct or indirect tissue contact must meet these stringent requirements.
Durability
Implantable medical device packaging labels must endure sterilization processes like high-heat autoclaving, gamma radiation, or ethylene oxide (EtO) sterilization to ensure they remain intact and legible. The durability of labels is crucial to maintaining traceability and compliance during sterilization and handling.
Legibility
ISO 20417 and other UDI-specific requirements mandate that labels resist fading, smearing, and other forms of degradation over the product’s lifecycle. This is critical to ensure UDI codes remain legible for accurate traceability and compliance. Thermal transfer printing is a widely used technology for medical device labels due to its ability to produce durable, high-resolution text and barcodes that can withstand handling, sterilization, and environmental exposure.
Adhesives
Medical-grade adhesives play a vital role in ensuring implantable medical device labels stay securely attached through sterilization, handling, and storage. Adhesives used for such labels must be chemically stable, biocompatible, and resistant to environmental stresses like extreme temperatures or cryogenic conditions. The biocompatibility and stability of adhesives are assessed under ISO 10993 standards to minimize contamination risks and ensure patient safety.
Demystifying ISO standards for implantable medical device labels
Even the most high tech medical device companies likely don’t have a label expert on staff to ensure that every label meets ISO standards and global health regulations. And one tiny mistake could mean a patient is harmed or big fines from FDA or EU compliance failures. CleanMark’s custom labels are the answer.
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References
- https://www.iso.org/obp/ui/#iso:std:iso:15223:-1:ed-4:v1:en
- https://www.iso.org/obp/ui/#iso:std:iso:15223:-2:ed-1:v1:en
- https://www.iso.org/obp/ui/#iso:std:iso:11607:-1:ed-2:v1:en
- https://www.iso.org/obp/ui/en/#iso:std:iso:10993:-1:ed-5:v2:en
- https://www.iso.org/obp/ui/en/#iso:std:iso:20417:ed-1:v2:en
- https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/updated-requirements-and-guidance-on-symbols-for-use-with-medical-devices/
- https://blog.johner-institute.com/regulatory-affairs/iso-20417/
- https://blog.johner-institute.com/regulatory-affairs/iso-15223-1/