British Standards Institution

Sector: Manufacturing

Overview: Under the direction of the Standards Policy and Strategy Committee, is responsible for the UK input into ISO/TC 150/SC 7, ISO/TC 276 and CEN/TC 233 as well as providing input on UK strategy for standardization in biotechnologies through a broad consultation with relevant stakeholders

Committee standards activity

In Progress (64)

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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.
Resolution 59/2022/01 -	PWI Gene delivery systems Part 3 Categories: Information management \| Standardization. General rules \| Measurement and Science \| Biology. Botany. Zoology Proposal begins : 2022-12-23	Proposal
Resolution 58/2022/01 - PWI Ultra low concentration NA	ISO/TC 276 approves the registration of a new PWI on Biotechnology — General requirement for measurement of ultra-low concentration sample of target nucleic acid sequence into its work programme. The project will be handled within ISO/TC 276/WG 3. Categories: Information management \| Standardization. General rules \| Measurement and Science \| Biology. Botany. Zoology Proposal begins : 2022-12-21	Proposal
PD ISO/TS 9491-2	Biotechnology — Predictive computational models in personalized medicine research — Part 2: Guidelines for implementing computational models in clinical integrated decision support systems Categories: Unclassified documents Drafting begins : 2025-01-06	Drafting
PD ISO/TS 20853	Biotechnology — Bioprocessing — General requirements for the bacteriophage preparation for therapeutic use Categories: Unclassified documents Drafting begins : 2025-07-18	Drafting
PD ISO/TR 24560-1	Tissue engineered medical products -- MRI evaluation of cartilage. Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolimium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping Categories: Implants for surgery, prosthetics and orthotics Drafting begins : 2019-10-12	Drafting
PD ISO/TR 20396-1	Biotechnology - Data publication. Part 1: Considerations and concepts Categories: Unclassified documents Proposal begins :	Proposal
PD ISO/TR 20386	Inventory of biotechnology-related terms Categories: Unclassified documents Approval begins :	Approval
ISO/TC 276 N 622, ISO/PWI 24420	Biotechnology - Massively parallel DNA sequencing - General Requirements for Data Processing of Shotgun Metagenomics Categories: Information management \| Standardization. General rules \| Measurement and Science \| Mathematics. Natural Sciences \| Biology. Botany. Zoology \| Microbiology \| Microbiology. Other Proposal begins : 2020-04-02	Proposal
ISO/TC 276 N 614, ISO/PWI 24421	Biotechnology -- Minimum requirements for optical signal measurements in photometric methods for biological samples Categories: Information management \| Standardization. General rules \| Measurement and Science \| Mathematics. Natural Sciences \| Biology. Botany. Zoology \| Microbiology \| Microbiology. General Proposal begins : 2020-03-26	Proposal
ISO/TC 276 N 609, ISO/NP 5058-1	Biotechnology - Genome Editing - Part 1: Terminology Categories: Information management \| Terminology. Principles and coordination \| Standardization. General rules \| Measurement and Science \| Mathematics. Natural Sciences \| Biology. Botany. Zoology \| Microbiology Proposal begins : 2020-03-26	Proposal

Published (66)

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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 9491-1:2023	Biotechnology. Predictive computational models in personalized medicine research. Constructing, verifying and validating models Categories: Biology. Botany. Zoology Published standard begins : 2023-08-31	Published standard
PD ISO/TS 24560-1:2022	Tissue-engineered medical products. MRI evaluation of cartilage. Clinical evaluation of regenerative knee articular cartilage using delayed gadolimium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2022-08-12	Published standard
PD ISO/TS 24420:2023	Biotechnology. Massively parallel DNA sequencing. General requirements for data processing of shotgun metagenomic sequences Categories: Biology. Botany. Zoology Published standard begins : 2023-05-25	Published standard
PD ISO/TS 23565:2021	Biotechnology. Bioprocessing. General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use Categories: Biology. Botany. Zoology Published standard begins : 2021-12-13	Published standard
PD ISO/TS 23511:2023	Biotechnology. General requirements and considerations for cell line authentication Categories: Biology. Botany. Zoology Published standard begins : 2023-06-07	Published standard
PD ISO/TS 23494-1:2023	Biotechnology. Provenance information model for biological material and data. Design concepts and general requirements Categories: Biology. Botany. Zoology Published standard begins : 2023-04-26	Published standard
PD ISO/TS 23105:2021	Biotechnology. Biobanking. Requirements for the biobanking of plant biological material for research and development Categories: Biology. Botany. Zoology Published standard begins : 2021-11-01	Published standard
PD ISO/TS 22859-1:2022	Biotechnology. Biobanking. Requirements for human mesenchymal stromal cells derived from umbilical cord tissue. General guidelines for biobanking of human mesenchymal stem and stromal cells derived from umbilical cord Categories: Biology. Botany. Zoology Published standard begins : 2022-08-23	Published standard
PD ISO/TS 21560:2020	General requirements of tissue-engineered medical products Categories: Implants for surgery, prosthetics and orthotics Published standard begins : 2020-10-02	Published standard
PD ISO/TS 20388:2021	Biotechnology. Biobanking. Requirements for animal biological material Categories: Biology. Botany. Zoology Published standard begins : 2021-12-09	Published standard

Withdrawn (8)

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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 20399-3:2018	Biotechnology. Ancillary materials present during the production of cellular therapeutic products. Best practice guidance for ancillary material users Categories: Biology. Botany. Zoology Withdrawn begins : 2023-01-16	Withdrawn
PD ISO/TS 20399-2:2018	Biotechnology. Ancillary materials present during the production of cellular therapeutic products. Best practice guidance for ancillary material suppliers Categories: Biology. Botany. Zoology Withdrawn begins : 2023-01-16	Withdrawn
PD ISO/TS 20399-1:2018	Biotechnology. Ancillary materials present during the production of cellular therapeutic products. General requirements Categories: Biology. Botany. Zoology Withdrawn begins : 2023-01-16	Withdrawn
BS ISO 5058-1:2021	Biotechnology. Genome editing. Vocabulary Categories: Mathematics. Natural sciences \| Biology. Botany. Zoology Withdrawn begins : 2022-08-26	Withdrawn
BS ISO 21709:2020	Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines Categories: Biology. Botany. Zoology Withdrawn begins : 2021-09-28	Withdrawn
BS ISO 20387:2018	Biotechnology. Biobanking. General requirements for biobanking Categories: Biology. Botany. Zoology Withdrawn begins : 2020-10-02	Withdrawn
BS EN ISO 22442-2:2015	Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling Categories: \| Medical devices. Biological evaluation \| Laboratory medicine. Other Withdrawn begins : 2020-12-14	Withdrawn
BS EN ISO 22442-1:2015	Medical devices utilizing animal tissues and their derivatives. Application of risk management Categories: \| Medical devices. Biological evaluation \| Laboratory medicine. Other Withdrawn begins : 2020-12-14	Withdrawn

Message Committee Become a committee member

Committee members

Nominating organizations

A B H I - Association of British Healthcare Industries
Advanced Biologics
Associate Committee Manager
AstraZeneca P L C
C P I - Centre for Process Innovation Ltd
Cell & Gene Therapy Catapult
Clinical Biotechnology Centre
CN Bio
Committee Manager
Heriot-Watt University
Human Tissue Authority
M H R A - Medicines and Healthcare products Regulatory Agency
MedPass International Ltd
MRC Centre for Regenerative Medicine
National Measurement Laboratory
NC3Rs
Oxford e-Research Centre
STEMCELL Technologies UK Ltd.
The Francis Crick Institute
Thermo Fisher Scientific Corporation
UK Health Security Agency (UKHSA)
University College London
University of Leicester

Liaisons with other committees

Chair - CH/150
Co Opted
Individual Capacity - Cells, Biobanking & Clinical Applications
Individual capacity – Medical devices

BSI roles

Committee Chair

Standards Development

BTI/1 - Biotechnologies

Committee standards activity