ISO 18162-2024 PDF

Full title and description

ISO 18162:2024 — Biotechnology — Biobanking — Requirements for human neural stem cells derived from pluripotent stem cells. This international standard specifies quality, handling and biobanking requirements specifically for human neural stem cells (hPSC‑NSCs) obtained from human pluripotent stem cells (hPSCs), covering their differentiation, culture, characterization, quality control, storage, thawing and transport for research and development use.

Abstract

This document sets out requirements and recommended practices for the biobanking lifecycle of hPSC‑NSCs intended for research and development: from in‑lab differentiation and expansion through characterization and QC, long‑term preservation, thawing and distribution. It excludes materials intended for in‑vivo clinical or therapeutic human application and refers to complementary standards (e.g., ISO 24603) for upstream collection and handling of source pluripotent cells.

General information

• Status: Published.
• Publication date: December 2024.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 07.080 (Biotechnology).
• Edition / version: Edition 1 (2024).
• Number of pages: 25.

Scope

Applicable to organizations performing biobanking of human neural stem cells derived from pluripotent stem cells for research and development. The standard addresses requirements for differentiation protocols, culture and expansion, characterization and QC, preservation and storage conditions, thawing procedures, transport, documentation and traceability. It does not apply to hPSC‑NSCs intended for in‑vivo human therapeutic use; collection and initial handling of biological source material and pluripotent stem cells are covered by ISO 24603.

Key topics and requirements

• Specification of acceptable source material and reference to upstream requirements (see ISO 24603) for collection and establishment.
• Requirements for differentiation and culture methods tailored to produce reproducible hPSC‑NSC populations.
• Characterization and identity testing (morphology, marker expression, potency assays) and routine quality control workflows.
• Requirements for cryopreservation, validated storage conditions, sample labelling and inventory management to ensure traceability.
• Validated thawing and post‑thaw recovery procedures and acceptance criteria.
• Documentation, recordkeeping, chain‑of‑custody, donor consent considerations (where applicable) and data management best practices.
• Transport and distribution controls for maintaining sample integrity during shipment.
• Risk assessment, change control and corrective actions relevant to biobank operations for hPSC‑NSCs.

Typical use and users

Designed for biobanks, cell repositories, research laboratories, quality managers, technical staff handling stem‑cell derived neural cell banks, contract research organizations (CROs) and regulatory affairs personnel involved in preclinical research material management. Useful for organizations seeking consistent, documented processes for producing, storing and sharing hPSC‑NSC materials for R&D.

Related standards

Key related documents include ISO 24603 (Requirements for human and mouse pluripotent stem cells — covers collection, establishment and upstream handling) and ISO 20387 (General requirements for biobanking). Users should consult these and other ISO/TC 276 outputs for broader biobanking quality systems and implementation guidance.

Keywords

hPSC‑NSC, human neural stem cells, pluripotent stem cells, biobanking, cryopreservation, quality control, characterization, traceability, ISO 18162, ISO 24603, ISO 20387.

FAQ

Q: What is this standard?

A: ISO 18162:2024 is an international standard that specifies requirements for biobanking human neural stem cells derived from pluripotent stem cells, focused on processes and quality controls used for research and development materials.

Q: What does it cover?

A: It covers differentiation, culture, characterization, quality control, cryopreservation, storage, thawing, transport, documentation and traceability for hPSC‑NSCs. It excludes material intended for in‑vivo human therapeutic use and defers to ISO 24603 for source material collection and initial handling.

Q: Who typically uses it?

A: Biobanks, research labs, cell repositories, CROs, QA/QC staff and regulatory/compliance teams working with stem‑cell derived neural materials for R&D.

Q: Is it current or superseded?

A: As published in December 2024, ISO 18162:2024 is the current edition (Edition 1) for this topic. Organizations should monitor ISO and national body announcements for any future revisions or corrigenda.

Q: Is it part of a series?

A: Yes — it is part of ISO/TC 276 activities on biotechnology and biobanking and is intended to be used alongside related standards such as ISO 24603 (pluripotent stem cells) and ISO 20387 (general biobanking requirements).

Q: What are the key keywords?

A: hPSC‑NSC, neural stem cells, pluripotent stem cells, biobanking, cryopreservation, characterization, quality control, traceability, ISO 18162.