ISO 25424:2018/Amd 1:2022

Overview

ISO 25424:2018/Amd 1:2022 is an important international standard issued by ISO, focused on the sterilization of health care products using low temperature steam and formaldehyde. This amendment updates requirements related to the development, validation, and routine control of sterilization processes for medical devices. It reflects the latest advancements and ensures enhanced safety and efficacy in sterilization practices applied in healthcare settings.

This standard plays a critical role in guiding manufacturers, healthcare providers, and regulatory bodies on maintaining the sterility and functional integrity of medical devices through controlled sterilization methods. It is published by ISO Technical Committee ISO/TC 198 in collaboration with the European Committee for Standardization (CEN) TC 204 under the Vienna Agreement.

Key Topics

• Low Temperature Steam and Formaldehyde Sterilization
  The standard covers the sterilization process combining low temperature steam and formaldehyde gas, an effective method for heat-sensitive medical devices.

• Process Development and Validation
  It defines protocols required for developing a validated sterilization cycle, ensuring that medical devices consistently meet sterility assurance levels without compromising device functionality.

• Routine Process Control
  Requirements for monitoring and controlling the sterilization process during routine production are clarified, including the use of chemical and biological indicators to verify sterility.

• Terminology Updates
  The amendment refines definitions important to the sterilization process, such as adjustments in terms related to medical devices and microbial inactivation curves to enhance clarity and standardization.

• Environmental and Safety Considerations
  References to environmental impact and emission controls are updated, covering different phases of the product life cycle, including production and end-of-life stages.

Applications

ISO 25424:2018/Amd 1:2022 is widely applicable across healthcare and medical device industries, including:

• Medical Device Manufacturers
  Enabling manufacturers to design and implement effective sterilization processes tailored to devices sensitive to conventional high-temperature methods.

• Healthcare Facilities
  Assisting hospitals and clinics in validating and monitoring sterilization equipment that utilizes low temperature steam and formaldehyde, ensuring patient safety.

• Regulatory Compliance
  Providing a framework to meet international regulations for sterilization standards, supporting product market access and quality assurance.

• Sterilization Equipment Providers
  Guiding the design and validation of sterilization equipment to comply with internationally recognized performance criteria.

Related Standards

• ISO 11139:2018
  Provides definitions and concepts regarding sterilization processes, referenced for consistent terminology such as "inactivation curve."

• ISO 13485:2016
  Specifies quality management requirements for medical device manufacturers, linked with terminology and validation principles used in this standard.

• ISO/IEC Directives, Part 1 and 2
  Outline procedures and editorial rules followed during the preparation and maintenance of the standard, ensuring conformity and clarity.

Practical Value

By adhering to ISO 25424:2018/Amd 1:2022, stakeholders can expect:

• Reliable sterilization outcomes optimized for heat-sensitive medical devices.
• Clear validation pathways that reduce the risk of product recalls and infections.
• Harmonized terminology and definitions aiding communication and regulatory approval.
• Improved environmental management during the sterilization process lifecycle.

This amendment is a key resource for enhancing the safety and efficacy of medical device sterilization, contributing significantly to patient care standards around the globe.