The Applied Technical Services Family of Companies sterilizes healthcare products in compliance with the ISO 11137: Radio Sterilization Standard.
What is ISO 11137?
The International Organization for Standardization (ISO) established ISO 11137 as the standard procedure for sterilizing healthcare products using radiation, specifically gamma radiation. ISO 11137 has three parts: ISO 11137-1, -2, and -3.
ISO 11137-1
ISO 1137-1 specifies the requirements for controlling, validating, and developing the radiation process.
ISO 11137-2
ISO 11137-2 addresses the methods manufacturers use to verify the minimum dose needed to sterilize a medical device.
ISO 11137-3
ISO 11137-3 provides manufacturers with guidelines on how to comply with ISO 11137-1 and correctly measure gamma ray dosage. Applied Technical Services can help our clients do the following:
- Conduct Sterility Testing
- Ensure Compliance with Relevant Standards
- Validate the Sterilization of Medical Devices
The Importance of Medical Device Sterilization
Medical devices are machines, appliances, and instruments used to diagnose, treat, or prevent disease or illness. These devices often encounter sensitive body tissues and fluids, so they must undergo a precise sterilization process. Failure to do so may result in the spread of dangerous bacteria that can compromise the equipment’s safety and the patient’s health.
The Benefits of Radiation Sterilization
Radiation sterilization offers several advantages over alternative sterilization methods, including the following:
- Cost-Effective
- Simple to Use
- Higher Level of Sterilization Assurance
- Safer Application
- Practical Regardless of Pressure Conditions and Temperature
- Environmentally Safe
Several other industries use gamma radiation for sterilization, including:
- Agriculture
- Cosmetics
- Pharmaceutical
- Packaged Foods
Our Commitment to Quality
Founded in 1967, we’ve established ourselves as a reliable and reputable consulting engineering, testing, and inspection firm. We are an ISO 9001:2015 registered quality management system with an unrivaled commitment to improving and expanding our services. To ensure the satisfaction of our clients, we offer the following:
- Outstanding Customer Service
- Quick Turn-Around Times
- Knowledgeable and Professional Personnel
- Honest and Ethical Business Practices
Please consider the ATS FoC for your ISO 11137: Radiation Sterilization needs and submit an online request form for a free quote today.
