ABNT NBR 16328:2024 and ISO 17665:2024 norms update
ABNT NBR 16328 and ISO 17665 are essential standards for the sterilization of healthcare products, specifically for measuring temperature, humidity, and pressure in thermal equipment. Both standards were updated in 2024, reflecting advancements in thermal qualification and equipment calibration processes within the healthcare industry.
The ABNT NBR 16328 was first published in 2014 and underwent updates in 2019, 2023, and 2024. Initially, the standard included seven annexes, but it has now expanded to 14, covering protocols, specific test notes, and detailed qualification procedures for various thermal equipment such as freeze-dryers and vacuum ovens.
The ISO 17665, focusing on steam sterilization, consolidated its parts into a single document in 2024. This updated version now covers calibration details, the use of biological indicators, and comprehensive guidelines for vapor quality control.
Key Updates
- ABNT NBR 16328:2024
- New Annexes: Expanded from 7 to 14 annexes, including procedures for new equipment like freeze-dryers, reactors, and vacuum ovens.
- Calibration Details: Added detailed information on calibration frequency, methods, and responsibilities.
- Qualification Protocols: Emphasized protocol development, incorporating new tests and specific recommendations.
- Explanatory Notes: Introduced best practices for tests such as door opening and power failure simulations in cooling chambers.
- ISO 17665:2024
- Document Consolidation: Unified in a single module, covering microbiological conditions of raw materials, vapor quality, and load qualification.
- Biological Indicators: New guidance on using biological indicators with lower spore populations, offering flexibility for sterilization testing.
These updates ensure more rigorous control and detailed processes for the qualification and validation of equipment, enhancing the effectiveness of sterilization processes and increasing the safety of healthcare products. The changes reflect continuous adaptation to regulatory and technological needs within both national (ABNT) and international (ISO) contexts. ABNT NBR 16328:2024 and ISO 17665:2024 establish essential standards to ensure the quality and safety of healthcare sterilization processes. Adhering to these guidelines is crucial for regulatory compliance and maintaining robust practices within the healthcare industry.