ISO/TR 19478-1:2014 PDF

Overview

ISO/TR 19478-1:2014 - "ISO and Health Canada intense smoking parameters - Part 1: Results of an international machine smoking study" documents an international collaborative study organized by ISO/TC 126 Working Group 10 (WG 10). The Technical Report describes the 2010–2011 inter‑laboratory study comparing the standard ISO machine smoking regime (ISO 3308) with the Health Canada Intense (HCI) smoking regime. It explains the study design, participating laboratories, test articles, raw data handling and statistical analysis of smoke yields.

Key topics and technical content

• Study scope and objectives
  • Measure mainstream smoke yields of TPM (total particulate matter), NFDPM (nicotine‑free dry particulate matter), nicotine, CO (carbon monoxide), water, puff count and cigarette mass under both ISO and HCI regimes.
  • Determine intra‑ and inter‑laboratory variability (repeatability r and reproducibility R).
• Collaborative study design
  • 35 participants from 21 countries; eight commercial cigarette products plus two reference/monitor cigarettes (CM6 and 1R5F).
  • Use of both linear and rotary smoking machines (about 21 linear, 23 rotary; 42 machines used in statistical evaluation).
• Smoking regimes and parameters
  • ISO regime: 35 ml puff volume, 60 s puff interval, 2 s duration, no ventilation blocking.
  • HCI regime: 55 ml puff volume, 30 s interval, 2 s duration, 100% filter ventilation blocking.
• Data handling and analysis
  • Results include raw yields, outlier testing, mean yields after outlier removal, and calculation of repeatability (r) and reproducibility (R).
  • Data analysed according to ISO 5725 methods for precision of measurement.
• Comparative evaluation
  • Detailed comparisons of ISO vs HCI yields and assessment of variability between linear and rotary machines.

Practical applications and users

This Technical Report is valuable for:

• Analytical laboratories conducting cigarette smoke chemistry testing and proficiency studies.
• Regulatory authorities and public health agencies assessing machine smoking regimes and method comparability.
• Tobacco manufacturers and quality control teams implementing routine measurement protocols and evaluating inter‑laboratory performance.
• Researchers and standards developers studying sources of variability and refining machine smoking procedures.

Practical uses include benchmarking method performance, informing selection of smoking regimes for routine testing, and supporting inter‑lab harmonization and quality assurance.

Related standards

• ISO 3308 (machine smoking routine parameters)
• ISO 5725 (accuracy - repeatability and reproducibility)
• Health Canada Method T‑115 (HCI regime)
• ISO/TR 19478‑2 (Part 2: factors contributing to variability)