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Ben Kemp

ConsultationsConsultations Archive

62A/1516/NP Medical devices – Guidance on the application of ISO 14971 – Part 2: Machine learning in artificial intelligence

Comment period start date: 16/08/2023 Comment period end date: 03/10/2023 Scope This document provides guidance for applying an ISO 14971 risk management process when evaluating medical technology utilizing machine learning (ML). It is intended to apply to ML-enabled medical devices throughout all phases of the product lifecycle. This document is intended to be used in conjunction with ISO 14971. It…
Ben Kemp
September 8, 2023
ConsultationsConsultations Archive

62/474/NP Machine Learning-enabled Medical Device – Performance Evaluation Process

Comment period start date: 16/08/2023 Comment period end date: 03/10/2023 Scope This document defines a standardized performance evaluation process for Machine Learning-enabled Medical Devices (MLMD). The set of processes, activities, and tasks described in this document establishes a common framework for MLMD performance evaluation. Purpose The evaluation of ML performance is a crucial factor in measuring the overall MLMD’s performance.…
Ben Kemp
September 8, 2023
ConsultationsConsultations Archive

BS EN IEC 61267 Ed.3.0 BS EN 61267 Ed.3.0 Medical diagnostic X-ray equipment – Radiation conditions for use in the determination of characteristics

Comment period start date: 17/08/2023 Comment period end date: 04/10/2023 Scope In addition to the requirements of IEC 61326-1, this part of IEC 61326 specifies the EMC test requirements for process automation equipment using at least one Ethernet-APL (Ethernet Advanced Physical Layer) compliant port. The type of equipment covered by this part includes infrastructure devices such as switches as well…
Ben Kemp
September 8, 2023
ConsultationsConsultations Archive

Draft Decision CEN/TC 206 002/2023 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants

Comment period start date: 04/08/2023 Comment period end date: 11/09/2023   Scope This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart…
Ben Kemp
September 8, 2023
ConsultationsConsultations Archive

Draft Decision CEN/TC 206 003/2023 Medical devices utilizing human tissues and their derivatives — Application of risk management

Comment period start date: 04/08/2023 Comment period end date: 11/09/2023 Scope This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices,…
Ben Kemp
September 8, 2023
ConsultationsConsultations Archive

ISO/NP TS 23918 Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence

Comment period start date: 16/08/2023 Comment period end date: 08/10/2023 Scope This document provides guidance for applying an ISO 14971 risk management process when evaluating medical technology utilizing machine learning (ML). It is intended to apply to ML-enabled medical devices throughout all phases of the product lifecycle. This document is intended to be used in conjunction with ISO 14971. It…
Ben Kemp
September 8, 2023
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Consultation: The disclosure of industry payments to the healthcare sector

Consultation description We want to seek views on the possible introduction of new secondary legislation to place a duty on manufacturers and commercial suppliers of medicines, devices and borderline substances to report details of the payments and other benefits they provide to healthcare professionals and organisations. This consultation aims to address the second part of recommendation 8 contained in the Independent…
Ben Kemp
September 8, 2023
ConsultationsConsultations Archive

ISO/PWI TS 8219 Sequencing and clinical application to infectious diseases

Comment period start date: 03/08/2023 Comment period end date: 24/09/2023 Comment by: 24th Sep Scope This technical specification details the requirements, and provides guidance for the application of advanced sequencing procedures for direct identification and characterisation without culturing of microbial causes of human infectious disease; sometimes termed clinical metagenomics. This document covers considerations associated with specimen collection, processing, nucleic acid…
Ben Kemp
September 8, 2023
ConsultationsConsultations Archive

ISO/PWI TS 20853 Biotechnology — Bioprocessing — General requirements for the bacteriophage preparation for therapeutic use

Proposal start date: 11/07/2023 Proposal end date: 02/09/2023   Scope This document describes the minimum requirements for bacteriophage preparation processing including the assessment of the titer and quality control. This document applies to data processing of bacteriophage isolation, culture, purification and storage. This document applies to the quality evaluation/assessment of bacteriophage used for therapy. Purpose With the continuous and expanded…
Ben Kemp
September 8, 2023
HighlightsHighlights Archive

Media Monitoring: 2nd – 8th September

  UK government sets out AI Safety Summit ambitions Five objectives of the AI Safety Summit to be progressed shared by UK Government UK will work closely with global partners to make frontier AI safe, and to ensure nations and citizens globally can realise its benefits AI Safety Summit will bring key countries, leading technology organisations, academia and civil society together   Joint Statement of…
Ben Kemp
September 8, 2023
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