British Standards Institution

Sector: Governance & Resilience

Overview: CH/212 is responsible for standardization in the field of in vitro diagnostics (IVDs). It is the UK mirror committee for: ISO/TC 76 Transfusion, infusion and injection equipment for medical and pharmaceutical use; ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems; CEN/TC 140 In vitro diagnostic medical devices; Parts of the work of CEN/TC 205 Non-active medical devices; The areas covered are specifications, general requirements, and terminology.

Committee standards activity

In Progress (61)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 7446	ISO 35001 — Biorisk management for laboratories and other related organisations — Implementation guidance Categories: Unclassified documents Proposal begins :	Proposal
PD ISO/TS 24883	Lateral flow immunoassay for rapid diagnostic testing — General guideline for test performance Categories: Unclassified documents Proposal begins :	Proposal
PD ISO/TS 18702	Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood — DNA, RNA and proteins Categories: Unclassified documents Proposal begins :	Proposal
PD ISO/TS 18701	Molecular in vitro diagnostic examinations — Specificationsfor pre-examination processes for human specimens — Isolated microbiome DNA Categories: Unclassified documents Proposal begins :	Proposal
PD ISO/TR 23128	Medical devices -- Transfusion set and blood bag compatibility test method Categories: Transfusion, infusion and injection equipment Drafting begins : 2019-04-03	Drafting
ISO/TC 76 N 1445, ISO/NP 8417	Risk management of particulate contamination for devices with intravascular access Categories: Information management \| Standardization. General rules \| Healthcare \| Laboratory medicine \| Medical devices. Biological evaluation Proposal begins : 2021-06-16	Proposal
ISO/TC 76 N 1325, ISO/PWI 6717	In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans Categories: Information management \| Standardization. General rules \| Healthcare \| Laboratory medicine \| In vitro diagnostic test systems \| Medical devices. Biological evaluation \| Laboratory medicine. Other Proposal begins : 2020-01-02	Proposal
ISO/TC 76 N 1274	Medical devices -- Transfusion set and blood bag compatibility test method Categories: Measurement and Science \| Metrology and measurement \| Testing \| Testing. Non-destructive \| Healthcare \| Medical equipment \| Transfusion, infusion and injection equipment \| Surgical instruments and materials \| Hospital equipment Proposal begins : 2019-06-04	Proposal
ISO/TC 212 N 869, ISO/PWI 5649	Concepts and specifications for the design, development, production and use of in-house in vitro diagnostic medical devices (laboratory-developed tests) Categories: Information management \| Standardization. General rules \| Healthcare \| Laboratory medicine \| In vitro diagnostic test systems Proposal begins : 2021-08-17	Proposal
ISO/TC 212 N 866, ISO/NP 21474-3	In vitro diagnostic medical devices -- Multiplex molecular testing for nucleic acids -- Part 3: Interpretation and reports Categories: Information management \| Standardization. General rules \| Healthcare \| Laboratory medicine \| In vitro diagnostic test systems Proposal begins : 2021-08-17	Proposal

Published (146)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 5798:2022	In vitro diagnostic test systems. Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods Categories: Laboratory medicine. General Published standard begins : 2022-04-26	Published standard
PD ISO/TS 5441:2024	Competence requirements for biorisk management advisors Categories: Microbiology. General \| Laboratory medicine. General Published standard begins : 2024-05-21	Published standard
PD ISO/TS 23824:2024	Medical laboratories. Guidance on application of ISO 15189 in anatomic pathology Categories: Quality management and quality assurance \| Laboratory medicine. General Published standard begins : 2024-05-28	Published standard
PD ISO/TS 23128:2019	Medical devices. Transfusion set and blood bag compatibility test method Categories: Transfusion, infusion and injection equipment Published standard begins : 2019-12-20	Published standard
PD ISO/TS 22583:2024	Requirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipment Categories: Management. Human resources \| Laboratory medicine. General Published standard begins : 2024-10-02	Published standard
PD ISO/TS 20914:2019	Medical laboratories. Practical guidance for the estimation of measurement uncertainty Categories: Laboratory medicine. General Published standard begins : 2019-08-05	Published standard
PD ISO/TS 20658:2017	Medical laboratories. Requirements for collection, transport, receipt, and handling of samples Categories: Laboratory medicine. General Published standard begins : 2017-11-09	Published standard
PD ISO/TS 17822-1:2014	<i>In</i> <i>vitro</i> diagnostic test systems. Qualitative nucleic acid-based <i>in</i> <i>vitro</i> examination procedures for detection and identification of microbial pathogens. General requirements, terms and definitions Categories: Testing \| Laboratory medicine. General Published standard begins : 2014-12-17	Published standard
PD ISO/TS 17518:2015	Medical laboratories. Reagents for staining biological material. Guidance for users Categories: Laboratory medicine. General Published standard begins : 2015-05-01	Published standard
PD ISO/TS 16782:2016	Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing Categories: Medical devices. Biological evaluation Published standard begins : 2016-11-03	Published standard

Withdrawn (139)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 22583:2019	Guidance for supervisors and operators of point-of-care testing (POCT) devices Categories: Management. Human resources \| Laboratory medicine. General Withdrawn begins : 2024-10-02	Withdrawn
PD CEN/TS 17390-3:2020	Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Preparations for analytical CTC staining Categories: In vitro diagnostic test systems Withdrawn begins : 2024-11-14	Withdrawn
PD CEN/TS 17390-2:2020	Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Isolated DNA Categories: In vitro diagnostic test systems Withdrawn begins : 2024-11-14	Withdrawn
PD CEN/TS 17390-1:2020	Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Isolated RNA Categories: In vitro diagnostic test systems Withdrawn begins : 2024-11-14	Withdrawn
PD CEN/TS 17305:2019	Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA Categories: In vitro diagnostic test systems Withdrawn begins : 2021-11-04	Withdrawn
PD CEN/TS 16945:2016	Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma Categories: In vitro diagnostic test systems Withdrawn begins : 2021-06-07	Withdrawn
PD CEN/TS 16835-3:2015	Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free DNA from plasma Categories: Blood and urine. Analysis Withdrawn begins : 2019-10-28	Withdrawn
PD CEN/TS 16835-2:2015	Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated genomic DNA Categories: Blood and urine. Analysis Withdrawn begins : 2019-04-02	Withdrawn
PD CEN/TS 16835-1:2015	Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated cellular RNA Categories: In vitro diagnostic test systems Withdrawn begins : 2019-04-02	Withdrawn
PD CEN/TS 16827-3:2015	Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue. Isolated DNA Categories: In vitro diagnostic test systems Withdrawn begins : 2019-01-28	Withdrawn

Message Committee Become a committee member

Committee members

Nominating organizations

Altacor
Association of Clinical Biochemists
Becton Dickinson U.K. Ltd.
British in Vitro Diagnostics Association
British Society for Antimicrobial Chemotherapy
Committee Manager
Deputy Chair
FIND
G A M B I C A Association Limited
Haier Biomedical UK Ltd
Institute of Biomedical Science
L G C Group
Leeds Teaching Hospitals NHS Trust
LifeScan Scotland
M H R A - Medicines and Healthcare products Regulatory Agency
MedTech Europe
N I B S C - National Institute for Biological Standards and Control
Origin Sciences Limited
Oxford Nanopore Diagnostics
Quality Control for Molecular Diagnostics (QCMD)
Royal College of Pathologists
The Pharmaceutical Quality Group
UK Health Security Agency (UKHSA)
United Kingdom Accreditation Service
United Kingdom National External Quality Assessment Service
Vernacare Limited
Welsh Blood Service

Liaisons with other committees

Individual Capacity - Biomedical expertise and ISO/TC 212/WG 1
Individual Capacity - Clinical Evaluation & Risk Management
Individual Capacity - Infectious disease & molecular microbiology
Individual Capacity - Laboratory biosafety
Individual Capacity - Software IVDs and Electronic Instruments
Liaison - CPL/59
Liaison - RHE/18
UK Expert - ISO 20776-3

BSI roles

Committee Chair

Standards Development

CH/212 - IVDs

Committee standards activity