CSA-Z314-18 Canada Medical Device Reprocessing

The CSA Z314 standard was developed by the Canadian Standards Association (CSA) to describe criteria and test methods for reliable and efficient reprocessing of medical devices. The full name of this standard is as follows: CSA-Z314-18 Canadian medical device rework.

Medical devices are used in almost every healthcare facility. Patients and healthcare professionals expect these medical devices to be functional and microbiologically safe. The safety of medical devices begins with the manufacturer and is supported by a national standards system and legal regulations, which include medical device licensing, production and performance standards, and reporting systems.

The CSA Z314-18 standard is a standard prepared extensively according to the medical device reprocessing workflow, whether in a large hospital or a dentistry. It aims to benefit managers and employees in any healthcare institution where reworking of medical devices is performed.

This standard is a guide to installing a medical device that reworkes the quality management system. It also addresses employee training, occupational health and safety, and infection prevention and control. It also sets the following requirements for medical device rework workflow: decontamination and sterilization methods, sterile barrier systems, selection and use of gowns and drapes, storage, handling and distribution, and washing, care and preparation of reusable gowns, drapes and packaging. There are also 21 appendices that provide tools and additional guidance on topics covered in the standard.

Effective medical device rework is carried out when this standard is used in conjunction with several standards:

• CSA-C22.2 60601 series medical electrical devices
• C282-15 Emergency electrical power supply for buildings
• CSA-ISO 9001 Quality management systems
• CSA-ISO 11138-1 Sterilization of health care products
• CSA-ISO 11140-1 Sterilization of health products
• CSA-ISO 14937 Sterilization of health care products
• CSA-ISO 14971-07 Medical devices

CSA-Z314-18 Canadian medical device rework testing services are also provided to our businesses within the framework of laboratory testing services.