ISO 14698-2:2003 PDF

Name: ISO 14698-2:2003 — Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data
SKU: ISO 14698-2:2003
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Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data

Название (английский):

ISO 14698-2:2003

Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data

Статус документа:: Отменён
Формат:: Электронный (PDF)
Количество страниц:: 11
Дата публикации:: 10 октября 2003 г.
Издание:: ISO IS 14698 edition 1 version 1
ICS:: 13.040.35

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Описание (английский):

ISO 14698-2:2003 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control. It should be used, where appropriate, in conjunction with ISO 14698-1.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 14698-2:2003 - Cleanrooms and associated controlled environments - Biocontamination control - Part 2 provides guidance for the evaluation and interpretation of microbiological (biocontamination) data collected in risk zones. It complements ISO 14698-1 (general principles and sampling methods) and focuses on how to estimate results from sampling for viable particles (VU/CFU), set and verify limits, and manage routine and initial monitoring data for cleanrooms and controlled environments.

Key topics and technical requirements

Two-stage evaluation: separate guidance for the initial monitoring (set‑up) phase and the routine monitoring phase to establish reliable limits and ongoing control.

Data collection and sampling plans: emphasizes correct sampling, sample tracking, and the need for adequate sample homogeneity and dilution accuracy.

Terminology and levels: definitions and use of target, alert and action levels to trigger attention or corrective action when microbiological thresholds are exceeded.

Estimation and statistical treatment: guidance on estimation, data stratification (grouping), descriptive statistics, and the importance of using more than one statistical method to interpret results; the standard does not prescribe specific statistical formulas.

Trend analysis and control charts: recommends graphical presentations and control-chart methods (e.g., Shewhart charts, range-based charts, cumulative-sum charts) to distinguish normal variation from meaningful trends or excursions.

Out‑of‑specification handling: procedures for investigating abnormal results, identifying laboratory errors, and documenting corrective actions.

Records, validation and verification: strong emphasis on audit trails, documentation of methods and personnel, verification of monitoring/analytical methods, and periodic review of assigned microbiological classifications for risk zones.

Reporting and data integrity: requirements for consistent data recording, protection of electronic records, and traceability through the analytical process.

Practical applications

ISO 14698-2:2003 is applied where microbiological control of air, surfaces, and materials is critical. Typical uses include:

Establishing and validating microbiological monitoring programs in pharmaceutical, biotech and aseptic manufacturing

Interpreting environmental monitoring results in medical device production, hospitals and cleanroom facilities

Supporting quality assurance, production and regulatory compliance activities by defining alert/action procedures and documenting investigations

ISO 14698-2:2003 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications

Who should use this standard

Related standards

Технические детали

ISO 14698-1:2003

Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and…

BS EN ISO 14698-1:2003

Cleanrooms and associated controlled environments. Biocontamination control - General principles and methods

BS EN ISO 14644-13:2026

Cleanrooms and associated controlled environments. Cleaning of surfaces to achieve defined levels of cleanlin…

BS ISO 3534-4:2014

Statistics. Vocabulary and symbols. Survey sampling.

SIST EN ISO 9000:2015

Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)