ISO 6631:2025

Overview

ISO 6631:2025 - Tissue-engineered medical products - Quantification of bovine type I collagen marker peptide with liquid chromatography - Tandem mass spectrometry (LC‑MS/MS) provides a standardized LC‑MS/MS method for detecting and quantifying marker peptides specific to bovine type I collagen. The standard is intended for purified collagen products extracted from bovine tissues used in tissue‑engineered medical products (TEMPs) and other collagen‑based biomaterials to support product quality control, identification and species/type specificity.

Key topics and technical requirements

• Scope and applicability: Method applies to purified bovine type I collagen and can be used for qualitative/quantitative detection in mixtures containing other collagen types or animal sources. It can serve as a template for other collagen types/species when species‑ or type‑specific marker peptides are designed and methods optimized.
• Sample types: Covers liquid, solid and gel collagen samples; includes guidance on dissolution and handling of scaffolds or ECM‑containing materials (isolation/purification required before analysis).
• Sample preparation: Denaturation (heating), pH adjustment, and enzymatic digestion (trypsin) to generate marker peptides suitable for LC‑MS/MS.
• Controls and recovery: Use of recovery control samples (RCS) and standard curves for quantitation.
• LC‑MS/MS analysis: Specifies LC‑MS/MS detection principles, operating conditions (general), qualitative/quantitative detection parameters and data acquisition.
• Data processing: Standard curve construction, result calculation, acceptance criteria for experimental results and requirements for test reporting.
• Alternatives acknowledged: The document does not exclude other quantification methods (for example, hydroxyproline assays) that measure total collagen without type specificity.

Applications and users

ISO 6631:2025 is relevant to:

• Manufacturers of TEMPs and collagen biomaterials - for batch release testing and product quality control.
• Analytical and QC laboratories - implementing validated LC‑MS/MS assays for collagen identity and purity.
• Regulatory reviewers and auditors - assessing methods used for species/type identification and quantification in medical products.
• Researchers in regenerative medicine and biomaterials - studying collagen composition, source verification and degradation kinetics.

Practical uses include verifying bovine type I collagen content in grafts, scaffolds, wound dressings, and other collagen‑based formulations, and distinguishing bovine type I collagen from other types or species.

Related standards and methods

• Hydroxyproline quantification (total collagen content; lower specificity)
• Pharmacopoeial or national methods for collagen identification (document notes existing national examples)
• General LC‑MS/MS validation and quality assurance guidance (for method validation and reporting)

Keywords: ISO 6631:2025, bovine type I collagen, LC‑MS/MS, marker peptide, tissue‑engineered medical products, TEMPs, collagen quantification, quality control.