ISO/TR 13121:2011 PDF

Overview

ISO/TR 13121:2011 - Nanotechnologies - Nanomaterial risk evaluation is an ISO Technical Report that describes a practical, lifecycle‑focused process for identifying, evaluating, managing and communicating potential risks from manufactured nanomaterials. Intended as guidance (informative, not regulatory), the report helps organizations protect public health, workers, consumers and the environment by organizing and documenting information on nanomaterials, addressing uncertainty, and updating decisions as new data become available.

Key topics and technical requirements

This Technical Report structures a repeatable risk‑evaluation workflow and supporting activities:

• Five‑step process:
  • Describe materials and applications
  • Develop material profiles (physical/chemical properties, hazards, exposures)
  • Evaluate risks (hazard × exposure)
  • Assess risk management options
  • Decide, document and act - then review and adapt
• Material characterization: focus on manufactured nanomaterials (typically ≤100 nm in one, two or three dimensions) and their intended uses and sourcing.
• Profiles and data: creation of physical/chemical, hazard and exposure profiles; prioritization of data gaps and use of reasonable assumptions or default values where information is incomplete.
• Data quality and testing guidance: evaluation of data quality, tiered testing approaches, and use of “bridging information” when appropriate.
• Risk management and governance: assessment of controls (substitution, engineering, PPE), cross‑functional decision teams, documentation, stakeholder communication, transparency and accountability.
• Lifecycle and documentation: consideration of manufacture, distribution, use/reuse, maintenance and end‑of‑life, plus annexes providing example data sets, testing approaches and an output worksheet.

Practical applications

ISO/TR 13121:2011 is valuable for organizations and activities involving nanomaterials:

• Product stewardship and EHS programs - implement a structured nanomaterial risk evaluation process.
• R&D and product development - identify potential hazards and data gaps early in design.
• - evaluate exposure scenarios, workplace controls and supply‑chain documentation.