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Packaging Standards

ISO 11607 Parts 1 and 2 are the guidance documents for introducing new medical devices and packaging to the marketplace. These two standards cover “Requirements for materials, sterile barrier systems and packaging systems” and “validation requirements for forming, sealing and assembly processes”. ISO 16775 provides “guidance on the application of ISO 11607-1 and ISO 11607-2”. From the requirements outlined in these standards, Anecto provides consultancy and validation services to assist our clients to validate new packaging and products for the market. the following standards are used by Anecto as per the requirements of ISO 11607 Annex B.




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Case Study – Emerson Network Power

Case Study

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How Anecto developed a number of innovative solutions for the leading multinational Emerson Network Power.