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What is ISO 11607?

ISO 11607 is a two-part international standard:

  1. Part 1: Requirements for materials, sterile barrier systems, and packaging systems.
  2. Part 2: Validation requirements for forming, sealing, and assembly processes.

This standard applies to medical device packaging that is intended to maintain sterility up to the point of use. It is essential for ensuring that the packaging system is capable of withstanding various stress conditions like transport, sterilization, and storage while maintaining the sterility of the product.

Why is ISO 11607 important?

Global healthcare systems demand high standards of patient safety and hygiene. ISO 11607:2019 is indispensable for any organization involved in the production or distribution of terminally sterilized medical devices. It helps in:

  1. Ensuring regulatory compliance with FDA, EU MDR, and other national regulatory bodies.
  2. Reducing product recalls due to packaging failures.
  3. Supporting risk management practices as per ISO 14971.
  4. Facilitating smooth market approvals and audits worldwide.

ISO 11607 is often considered a mandatory requirement for CE marking and FDA approvals for sterile medical devices.

What are the benefits of ISO 11607?

  1. Compliance Assurance – Demonstrates conformance with international regulatory expectations.
  2. Improved Packaging Integrity – Ensures the packaging system consistently maintains sterility.
  3. Operational Efficiency – Validates packaging processes and reduces rework or rejects.
  4. Brand Reputation – Enhances trust among customers, healthcare professionals, and regulators.
  5. Supply Chain Optimization – Standardizes packaging procedures across global manufacturing locations.

What kind of businesses can benefit from ISO 11607?

At Growth Management Corporation, our consulting approach is result-driven and tailored for each client. Here’s how implementing ISO 11607:2019 can positively impact your business:

  1. ✅ Faster Market Access: Reduces approval timelines with recognized global compliance.
  2. ✅ Reduced Compliance Risks: Minimizes the chances of penalties, bans, or product withdrawals.
  3. ✅ Audit-Ready Systems: Makes you better prepared for FDA, ISO, or notified body inspections.
  4. ✅ Process Validation: Establishes robust, repeatable, and validated packaging processes.
  5. ✅ Competitive Edge: Adds value to your brand and strengthens client confidence in product safety.
  6. ✅ Global Recognition: Opens new international markets by aligning with global standards.
  7. ✅ Improved Product Lifecycle: Maintains product sterility over the defined shelf life.


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