Rang Dong Healthcare Officially Achieves ISO 11135:2014 Standard for Medical Products Company news       14/09/2023

In the context of the healthcare industry, healthcare services in Vietnam and worldwide are continually improving. The market for medical products is expanding with significant changes, leading to intense competition among providers. Therefore, Rang Dong Healthcare Joint Stock Company emerged with the criterion “for the community’s health as a foundation.” The products are manufactured to U.S. standards, marking a significant step forward for the healthcare industry in Vietnam. Rang Dong Healthcare has achieved the ISO 11135:2014 standard.

What is ISO 11135:2014?

ISO 11135:2014 is an international standard that establishes requirements for the development, validation, and routine control of ethylene oxide sterilization processes for medical devices. This standard was reviewed and confirmed in 2020. It includes the following requirements:

Identification of Sterilizing Agent

This section identifies requirements for sterilizing agents, including an overview, bactericidal effectiveness, material impact, safety, and environmental impact.

Process and Equipment Identification

The standard also specifies the identification of processes and equipment necessary for ethylene oxide sterilization.

Product Definition

This section defines product requirements, including product safety, quality, performance, and microbiological quality.

Applications of Ethylene Oxide

Ethylen oxide is widely used in various fields:

  • Production of other chemicals
  • Industrial products, personal care, and consumer goods
  • Medical equipment sterilization
  • Sterilization of some food products
  • Manufacture of chemicals for clothing, pillows, and carpets
  • Production of adhesives
  • Agricultural insecticide production
  • Antifreeze production

Medical Device Applications

ISO 11135:2014 applies to various medical devices, including:

  • Renal Support Equipment: Ethylene Oxide
  • Tubing/Blood Line Set: Ethylene Oxide
  • Gowns and Drapes: Ethylene Oxide
  • Heart Valves: Ethylene Oxide
  • Tachometer: Ethylene Oxide
  • Surgical Drill: Ethylene Oxide
  • Pump: Ethylene Oxide
  • Respirator: Ethylene Oxide
  • Peripheral Wound Dressing: Ethylene Oxide
  • Catheters and Leads: Ethylene Oxide

Each medical device in the table above undergoes ethylene oxide sterilization to ensure safety and effectiveness in use.

ISO 11135:2014 plays a crucial role in ensuring the safety and effectiveness of sterilizing medical devices and other products. With the development of the healthcare industry in Vietnam, compliance with this standard is essential to ensure the health of the population and instill confidence in medical products.