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BTI/1 - Biotechnologies

Sector: Manufacturing

Categories: | Laboratory medicine. Other | Microbiology. Other | Chemical industry products. General | | Sterilizing equipment | Microbiology | Alcohols. Ethers | Medical devices. Biological evaluation | Microbiology. General | Wastes. General | Protection against dangerous goods | Implants for surgery, prosthetics and orthotics | Biology. Botany. Zoology | Wastes. Special | Mathematics. Natural sciences | Product life-cycles | Pumps | Occupational safety. Industrial hygiene | Seals, glands | Microbiology. Medical | Chemical industry products. Other

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 (50)
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 : 2024-07-06
Drafting
PD ISO/TS 20853 Biotechnology — Bioprocessing — General requirements for the bacteriophage preparation for therapeutic use

Categories: Unclassified documents

Drafting begins : 2025-04-17
Drafting
PD ISO/TR 4752 Biotechnology — Inventory of methods for detection of microbiological contamination in mammalian cell culture

Categories: Unclassified documents

Drafting begins : 2024-04-03
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
Published (62)
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)
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