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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
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
ConsultationsConsultations Archive

ISO/NP TS 20510 Guidelines to use synthetic biological reference materials for nanoscale imaging by electron microscopy for life sciences and clinical diagnostics

This document provides an overview of measurement procedures for biological sample analysis using electron microscopy. This is exemplified by synthetic nanoscale biological materials that have undergone a series of inter-laboratory comparisons and is offered as the first metrologically traceable biological reference material for the characterisation of biological and patient biopsy specimen using electron microscopy. An emphasis is also made on…
Ben Kemp
January 27, 2023
Membership NewsMembership News Archive

BSI looking for contributors for safety requirements for electrical equipment for measurement, control and laboratory use standard

BSI have put a call out for those interested and knowledgeable in the field of electrical equipment for measurement, control and laboratory use, specifically for IVD equipment (BS EN 61010-2-101:2017, BS EN 61010-2-101:2017). This is to join their committee EPL/66, Safety of measuring, control and laboratory equipment’ in developing the above standard which is undergoing a revision. If you, or…
Ben Kemp
April 14, 2022