Japan, Ministry of Health, Labour and Welfare:
Points to Consider for Reprocessed Single-Use Medical Devices (Provisional Translation, December 2018) “…The [...]
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European Union, Medical Device Regulation of 2017, Regulation (EU) 2017/745 of the Euroepan Parliament and of the Council 5 April 2017, Article 17: GalleryEuropean Union, Medical Device Regulation of 2017, Regulation (EU) 2017/745 of the Euroepan Parliament and of the Council 5 April 2017, Article 17:
European Union, Medical Device Regulation of 2017, Regulation (EU) 2017/745 of the Euroepan Parliament and of the Council 5 April 2017, Article 17:
Single-Use Devices and their Reprocessing “…The reprocessing and further use of single-use devices [...]
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South Africa, Department of Health, Medicines and Related Substances Act, Regulations Relating to Medical Devices and In Vitro Medical Devices (9 December 2016) GallerySouth Africa, Department of Health, Medicines and Related Substances Act, Regulations Relating to Medical Devices and In Vitro Medical Devices (9 December 2016)
South Africa, Department of Health, Medicines and Related Substances Act, Regulations Relating to Medical Devices and In Vitro Medical Devices (9 December 2016)
“…’manufacture’ means operations that include the design, purchasing of material, specification development, production, [...]
World Health Organization:
WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical [...]
Nelson Labs:
Reprocessing Single-Use Devices (2016) “…There are many items that need to be addressed [...]
Center for Disease Control and Prevention (CDC):
Reuse of Single-Use Medical Devices, Guideline for Disinfection and Sterilization in Healthcare Facilities [...]
United Kingdom, Medicines & Healthcare Products Regulatory Agency:
Single-Use Medical Devices: UK Guidance on Re-Manufacturing (2016) “…Single-use devices may be re-manufactured [...]
Association for the Advancement of Medical Instrumentation:
AAMI TIR 30: A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria [...]
Premier Safety Institute:
Reprocessing Single-Use Devices https://www.premiersafetyinstitute.org/safety-topics-az/reprocessing-single-use-devices/reprocessing-single-use-devices/