Tag

Sterilisation

EN ISO 25424 updated as a harmonised standard to the IVDR European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

EN ISO 25424 updated as a harmonised standard to the IVDR

The European Commission has published confirmation that EN ISO 25424:2019 Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices is now harmonised to the IVDR.
admin
July 7, 2023
BS EN ISO 11137-1 Sterilization of health care products – Radiation. Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ConsultationsConsultations Archive

BS EN ISO 11137-1 Sterilization of health care products – Radiation. Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

This consultation ends on 7 June 2023. You can access the webpage by clicking here.
Ben Kemp
June 2, 2023
BS EN 556-2 EN 556-2 Sterilization of medical devices. Requirements for medical devices to be designated ”STERILE”. Part 2: requirements for aseptically processed medical devices ConsultationsConsultations Archive

BS EN 556-2 EN 556-2 Sterilization of medical devices. Requirements for medical devices to be designated ”STERILE”. Part 2: requirements for aseptically processed medical devices

This link contains further information and allows for the submission of comments. Comments must be submitted before 14 March 2023.
Ben Kemp
March 3, 2023
BS EN 556-1 EN 556-1 Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices ConsultationsConsultations Archive

BS EN 556-1 EN 556-1 Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices

This link contains further information and scope for comment. Please submit your comments by 14 March 2023.
Ben Kemp
March 3, 2023
BS EN 556-2 EN 556-2 Sterilization of medical devices. Requirements for medical devices to be designated ”STERILE”. Part 2: requirements for aseptically processed medical devices ConsultationsConsultations Archive

BS EN 556-2 EN 556-2 Sterilization of medical devices. Requirements for medical devices to be designated ”STERILE”. Part 2: requirements for aseptically processed medical devices

This document specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. Please comment by 14 March 2023. To access the full document, click here. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements…
Ben Kemp
January 27, 2023
BS EN 556-1 EN 556-1 Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices ConsultationsConsultations Archive

BS EN 556-1 EN 556-1 Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices

This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated “STERILE”. Comments can be submitted until 14 March 2023. For the full document, please click here. NOTE For the purpose of the EU Directive(s) for medical devices (see…
Ben Kemp
January 27, 2023