ISO 14160 Sterilization of Health Care Products - Liquid Chemical Sterilization Agents for Disposable Medical Devices Using Animal Tissues and Derivatives

EUROLAB laboratory provides testing and compliance services within the scope of ISO 14160 standard. The ISO 14160 standard, developed by the International Organization for Standardization (ISO), specifies requirements for the characterization of liquid chemical sterilization agent and the development, validation, process control and monitoring of sterilization with liquid chemical sterilization agents of disposable medical devices containing wholly or partly materials of animal origin.

This document covers the control of risks from bacterial and fungal contamination by applying the liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods. This document does not apply to materials of human origin.

This document does not describe methods for validation of inactivation of viruses and infectious spongiform encephalopathy (TSE) agents. This document does not describe methods for confirming inactivation or elimination of protozoa and parasites.

The verification and routine control requirements described in this document apply only to the defined sterilization process of a medical device performed after the manufacturing process and do not take into account the lethal effects of other bioburden reduction steps. This document does not specify tests to determine the effects of any selected sterilization treatment on the fitness for use of the medical device.

This document does not cover the level of sterilizing agent remaining in medical devices. Guidance is provided informatively for the characterization of the liquid chemical sterilization agent and the development, validation, process control and monitoring of the sterilization with liquid chemical sterilization agents of disposable medical devices composed wholly or partially of animal origin materials.

It is important to apply risk management principles upfront to medical devices using animal tissues, as described in ISO 22442-1. ISO 18362 provides information on the control of microbial risks during the processing of cell-based health care products.

Liquid chemical sterilizing agents traditionally used in medical devices to sterilize animal tissues may not be effective in neutralizing TSE-causing agents such as bovine spongiform encephalopathy (BSE) or scrapia. According to this document, satisfactory confirmation does not necessarily indicate inactivation of such infective agents. Risk controls related to the procurement, collection and processing of animal materials are described in ISO 22442-2.

Inactivation, elimination or elimination and verification of inactivation of viruses and TSE agents is described in ISO 22442-3. Manufacturing processes for medical devices containing animal tissues often involve exposure to chemicals that can significantly reduce the bioburden on the medical device. After the manufacturing process, the medical device is subjected to a certain sterilization process. Such tests are a crucial part of the design and development of a medical device.

Standards for quality management systems can be used to control all stages of manufacturing, including the sterilization process.

Among the services provided by our organization within the framework of material testing services, there are also ISO 14160 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.