Standards & Regulations

Cleanroom medical device packaging operation

Cleanroom Medical Device Packaging: ISO Standards & Sterile Barriers

Key Takeaways Cleanroom medical device packaging operates under ISO 14644 cleanliness classifications, most commonly ISO Class 7 or Class 8, with Class 5 reserved for implants and the highest-risk devices. Sterile barrier systems (SBS) follow ISO 11607-1 and ISO 11607-2,...

Medical Standards & Regulations

IVD diagnostic test packaging in a modern clinical laboratory setting

IVD Packaging: Sterile Barrier Requirements and EU IVDR Compliance

Key Takeaways IVD packaging must maintain the defined microbial or sterile state of the product from manufacture to point of use — whether the IVD is a reagent, test strip, sample container, or analyser component. EU IVDR 2017/746 GSPR 20.3...

Medical Standards & Regulations

EU MDR regulatory compliance documentation with medical device packaging

EU MDR Packaging Requirements: Complete Compliance Guide for Manufacturers

Key Takeaways EU MDR 2017/745 Annex I (GSPR 11) requires that sterile medical device packaging maintains its defined microbial state under manufacturer-specified storage and transport conditions. Compliance with EN ISO 11607-1/-2 is the primary harmonized route to demonstrating MDR packaging...

Medical Testing

Medical device packaging accelerated aging study in laboratory oven

Accelerated Aging Testing for Medical Device Packaging: ASTM F1980 Guide

Key Takeaways ASTM F1980 is the standard guide for accelerated aging of sterile barrier systems, enabling manufacturers to generate shelf life data without waiting for real-time studies to complete. The Arrhenius equation forms the mathematical basis of ASTM F1980: a...

Medical Standards & Regulations

Medical packaging laboratory with sterile Tyvek pouches

ISO 11607 Explained: Complete Guide to Medical Device Packaging Compliance

Key Takeaways ISO 11607 is the globally harmonized standard for packaging terminally sterilized medical devices, covering both materials (Part 1) and process validation (Part 2). Compliance with ISO 11607 satisfies both FDA 21 CFR Part 820 requirements and EU MDR...

Medical Testing

Seal integrity inspection of sterile medical device pouches in cleanroom

Seal Integrity Testing for Sterile Medical Packaging: Methods and Best Practices

Key Takeaways Seal integrity testing verifies that the seals of a sterile barrier system are free of defects that could allow microbial ingress, and is a mandatory element of ISO 11607 packaging validation. Testing methods divide into destructive (dye penetration,...