ISO 21321 is an international standard titled:
“Reusable medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices made of thermoplastics.”
This standard provides a framework for:
ISO 21321 is particularly relevant to surgical instruments, dental tools, and diagnostic devices made of thermoplastic materials that undergo repeated clinical use.
Reusable medical devices must undergo rigorous sterilization processes to ensure patient safety and regulatory compliance. Thermoplastics are commonly used in these devices due to their durability and ease of molding. However, without proper processing, these materials may degrade over time.
ISO 21321 helps organizations:
This standard is crucial for medical device manufacturers, hospital sterilization units, and regulatory consultants involved in product approval and usage.
Implementing ISO 21321 provides robust quality assurance for medical devices and reusable tools:
Adopting ISO 21321 offers clear business and operational advantages:
Fulfill requirements for global regulatory submissions and audits.
Boost trust among healthcare providers by offering reprocessing-validated products.
Access markets that mandate validated reprocessing information (e.g., EU, US, Canada).
Reduce costs by enabling safe reuse of devices rather than single-use reliance.
Seamlessly integrate with your existing quality management systems and technical documentation.
Promote eco-friendly healthcare through safe reuse practices and reduced waste
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