Assessing against Design Inputs

“At a high level, design inputs can be thought of as product attributes and product specific requirements.” (AAMI TIR 22 Annex D, Introduction)

The design inputs the packaging system should be assessed against include:

• Device attributes such as size, weight, profile, center of gravity, and surface characteristics.
• Device protection requirements or fragility levels: sensitivities to temperature, humidity, light, shock, vibration, and compression.
• Storage, distribution, and handling requirements.
• Manufacturing requirements: location, equipment, training, validations.
• Sterilization process requirements as recognized in Annex C: Sterilization Considerations.
• Marketing requirements: customer and marketing plans, and product and package configurations.
• Budget requirements through a supply-chain distribution.
• Customer requirements: A key point for a thorough understanding.
• Regulatory requirements, which may include others beyond those in Annex A: Web Sites and References.