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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
ConsultationsConsultations Archive

Consultation outcome: Antimicrobial resistance national action plan – call for evidence

  Detail of outcome The results of this call for evidence will inform the development of the next 5-year national action plan (NAP) on antimicrobial resistance (AMR), which will run from 2024 to 2029. The 2024 to 2029 NAP will continue being developed in consultation with a broad range of stakeholders across different sectors. It will build on the achievements of the…
Ben Kemp
August 25, 2023
ConsultationsConsultations Archive

UK SMI V 44: Laboratory diagnosis of syphilis

This consultation asks for feedback on UK SMI V 44: laboratory diagnosis of syphilis. This consultation closes at midday on 5 September 2023 Consultation description UK Health Security Agency (UKHSA) has opened a consultation in joint partnership with professional organisations. This consultation asks for feedback in relation to the UK Standards for Microbiology Investigations (UK SMI) V 44: laboratory diagnosis…
Ben Kemp
August 25, 2023
ConsultationsConsultations Archive

Consultation response – Draft evaluations of 3 chemical substances proposed as Persistent Organic Pollutants (POPs): call for comments

Defra held a call for comments on draft documents for 3 substances being proposed for listing as Persistent Organic Pollutants (POPs) on the UN Stockholm Convention. POPs proposals are sent to and reviewed by the Convention’s POPs Review Committee (POPRC). Comments received in this call were incorporated into the UK’s submission of comments to the Stockholm Convention’s POPRC as part of several commenting and redrafting cycles…
Ben Kemp
August 18, 2023
ConsultationsConsultations Archive

Government response to results of antimicrobial resistance (AMR) call for evidence

The results of this call for evidence will inform the development of the next 5-year national action plan (NAP) on antimicrobial resistance (AMR), which will run from 2024 to 2029. The 2024 to 2029 NAP will continue being developed in consultation with a broad range of stakeholders across different sectors. It will build on the achievements of the 2019 to 2024 NAP, while…
Ben Kemp
August 18, 2023
ConsultationsConsultations Archive

BS 2646-2 Autoclaves for sterilization in laboratories:. Part 2 – Guide to planning and installation

Scope This Part of BS 2646 gives recommendations on the planning for, and installation in laboratories of, autoclaves for the sterilization of goods and material which could be infected with organisms, the sterilization and/or processing of growth media or other materials required for the operation of a laboratory. You can respond here. Deadline: 30 August.
Ben Kemp
August 11, 2023
ConsultationsConsultations Archive

BS 2646-3 Autoclaves for sterilization in laboratories –. Part 3: Safe use and operation – Code of Practice

Comment by: 30th Aug Scope This Part of BS 2646 gives recommendations for the factors to be taken into account when devising procedures for the safe and effective use of laboratory autoclaves of the types specified in BS 2646‑1. NOTE 1 I.e. autoclaves for the sterilization of goods and material which could be infected with organisms, the sterilization and/or processing of growth media or…
Ben Kemp
August 11, 2023
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