Open Ballots and Comment Periods

Comments and/or input are currently being solicited on the following ballots, drafts, and work items. To provide comments, please contact SCB.

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TITLE * DEADLINE
ISO/NP 20399: Biotechnology – Ancillary materials present during the production of cellular therapeutic products October 23, 2019
ASTM WK69915: Reapproval of F2312-2011 Terminology Relating to Tissue Engineered Medical Products October 24, 2019
ISO/AWI 20397: Biotechnology -- Analytical Methods: General requirements for massive parallel sequencing - Part 1 nucleic acid and library preparation October 29, 2019
ISO/AWI TS 23565: Biotechnology -- Bioprocessing -- General requirements and considerations for equipment systems used in manufacturing of cellular therapeutic products October 31, 2019
ISO/AWI TS 23565: Biotechnology -- Bioprocessing: General requirements and considerations for equipment systems used for manufacturing of cellular therapeutic products October 31, 2019
ISO/AWI 23033: Biotechnology -- Analytical Methods: Cell Characterization -- General guide for cell characterization of human cells for therapeutic applications November 6, 2019
ISO/AWI 24190: Biotechnology -- Analytical Methods: Risk-based approach for design and validation of methods for rapid microbial detection in bioprocesses November 7, 2019
ISO: General requirements for packaging of package containing cells for therapeutic use November 19, 2019
ISO/DIS 21973 Biotechnology — General requirements for transportation of cells for therapeutic use November 26, 2019
ISO/DIS 21709 Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines December 2, 2019

* KEY:

  • AWI: Approved Work Item

  • CD: Committee Draft

  • DIS: Draft International Standard

  • FDIS: Final Draft International Standard

  • NP: New Proposal

  • NWIP: New Work Item Proposal

  • WD: Working Draft