ISO 16055:2021

Overview

ISO 16055:2021 - "Tobacco and tobacco products - Monitor test piece for smoking machine - Requirements and use" specifies requirements for producing, testing, documenting and using monitor test pieces (MTPs) that are used with cigarette-smoking machines. The standard defines MTPs as laboratory-only samples taken from a homogeneous production batch and validated to meet defined tolerances. ISO 16055:2021 focuses on ensuring analytical stability and process control for routine machine-smoking analyses, not on product calibration or human use.

Key topics and technical requirements

• Production from one batch: MTPs shall be produced from a single production batch with uniform tobacco, paper and filter materials to maximise homogeneity.
• Sufficient quantity: Produce enough MTPs to cover at least two years of laboratory use.
• Material restrictions: Prefer a single tobacco grade; only glycerol is allowed as humectant (propylene glycol prohibited).
• Unventilated recommendation: To stabilise carbon monoxide (CO) yields, non-ventilated (unventilated) filters are recommended.
• Tight physical controls: Mass, circumference and draw resistance must be tightly controlled; mass control is critical to minimise smoke-yield variation.
• Storage and labelling: Pack MTPs in hard boxes (20) labelled clearly “for laboratory purposes only, not for human consumption” and store at ≤ +4 °C until use.
• Interlaboratory testing: Validate smoke-yield consistency (nicotine-free dry particulate matter, nicotine, CO) via interlaboratory trials in accordance with ISO 5725-2; supply a data sheet with production specs and mean±SD results and 95% confidence intervals.
• Use and statistical control: Use MTPs to monitor analytical stability and whether machine-smoking processes are “in statistical control” using appropriate control charts (see ISO 7870-2). MTPs are explicitly not for calibration or to correct analytical results.

Practical applications

• Routine quality-control testing of cigarette-smoking machines to detect performance shifts.
• Monitoring day-to-day reproducibility of smoke-yield measurements (TPM, nicotine, CO).
• Supporting interlaboratory comparisons and method-validation studies.
• Supplier or reference-material producers creating standard monitor lots (e.g., CORESTA-type monitors).

Who should use this standard

• Tobacco analytical laboratories and QA/QC teams
• Regulatory and public-health laboratories conducting routine smoke analysis
• Manufacturers of smoking machines and test-piece producers
• Organisations running interlaboratory proficiency tests

Related standards

Key normative references include: ISO 3308, ISO 4387, ISO 8454, ISO 10315, ISO 10362‑1/2, ISO 20778, ISO 20779, ISO 22253, ISO 22947, ISO 5725‑2 and ISO 7870‑2 - all relevant to smoking regimes, analysis methods and statistical control.

Keywords: ISO 16055:2021, monitor test piece, smoking machine, tobacco testing, control charts, interlaboratory testing, smoking machine quality control.