The CSA-Z314-18 standard, published by the Canadian Standards Association (CSA), describes features for the safe and efficient reprocessing of reusable medical devices. The full name of this standard is as follows: CSA-Z314-18 Canadian medical device rework.
The standard includes key performance indicators, policies and procedures, documentation, roles and responsibilities, management review, planning, resources and operations, environmental conditions and infrastructure and warnings to create a quality management system for the reprocessing process.
It also describes staff requirements, including qualifications, occupational health and safety, and infection prevention and control.
This standard evaluates and purchases of rework equipment and reusable medical devices, the definition of reusable medical devices, work areas and design, environmental conditions, decontamination, preparation of medical devices for rework, sterile barrier systems, sterilization methods, storage, transportation and It sets out the principles for distribution methods, equipment maintenance and quality assurance, sterile storage conditions and washing, care and preparation of reusable gowns, drapes and packaging.
The areas in which this standard applies are: all acute care hospitals, trauma centers, emergency care facilities, medical clinics, endoscopy centers, laser eye clinics, outpatient services, cosmetic surgery centers, general dental and surgical facilities, other health surgical facilities, general doctor's offices , independent laboratory facilities, diagnostic imaging centers, nursing homes, mental health facilities, forensic facilities, rehabilitation facilities, additional service facilities, chronic care facilities, hospice care facilities, independent dialysis clinics, physiotherapy clinics, pediatric clinics, public health clinics and adult nursery.
This standard does not cover disposable medical devices.
CSA-Z314-18 Canadian medical device rework testing services are also provided to our businesses within the framework of laboratory testing services.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
