Overview
ISO 13079:2011, published by the International Organization for Standardization (ISO), establishes specifications for laboratory glass and plastics ware, specifically tubes used in the measurement of the erythrocyte sedimentation rate (ESR) by the Westergren method. This includes both single-use and re-usable Westergren tubes-sometimes referred to as Westergren pipettes-as well as the required tube support devices used during ESR testing.
The standard ensures that all tubes and supports used are designed and manufactured to facilitate accurate, reliable ESR measurements in clinical laboratories, supporting consistent results and safe laboratory practices.
Key Topics
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Materials and Construction:
- Requirements for both glass and transparent plastics, ensuring suitable rigidity and clarity.
- Plastics tubes must not release substances that could affect ESR results or display adhesive properties toward blood cells.
- Glass tubes must be free of visible defects and internal stress.
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Tube Types and Design:
- Specifications for single-use and re-usable Westergren tubes, including required straightness, finish, and dimensions.
- Detailed guidelines on tube graduation, inscriptions, and labelling for traceability and usability.
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Supports for Tubes:
- Construction criteria for supports to hold tubes securely and vertically, minimizing vibrations.
- Specifications for scale placement and durability to assist in precise sedimentation readings.
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Graduation and Marking Requirements:
- Tubes and supports must feature clear, permanent graduations in millimetres and standardized inscriptions.
- Packaging must include essential labelling, such as usage type, manufacturer details, batch reference, and conforming temperatures.
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Quality and Performance Testing:
- Type tests for tube rigidity, straightness, and potential contamination or interfering substances.
- Recommendations for cleaning and re-using glass tubes, ensuring safe and neutral operation environment.
Applications
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Clinical Laboratory Analysis:
- ISO 13079:2011 provides standardization for the key equipment used in erythrocyte sedimentation rate testing, significantly used for diagnosing and monitoring inflammatory and infectious diseases.
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Medical Equipment Manufacturing:
- Ensures that manufacturers produce Westergren tubes and supports that meet rigorous safety, material, and usability requirements, conforming to international standards.
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Quality Control in Healthcare:
- Promotes consistency and accuracy in ESR testing across different laboratories and healthcare facilities by unifying equipment specifications.
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Accreditation and Compliance:
- Laboratories adhering to ISO 13079:2011 can demonstrate compliance with globally recognized best practices, supporting accreditation and regulatory inspections.
Related Standards
- ISO 719: Defines hydrolytic resistance of glass grains, relevant for material selection of glassware described in ISO 13079:2011.
- ISO 15223-1: Specifies medical device symbols for labels and packaging, referenced in labelling requirements.
- Manufacturer and Procedure Guidelines: Additional national standards and laboratory manuals may further elaborate ESR procedures and equipment validation.
- NCCLS H2-A4: Recognized procedure for ESR testing, referenced in related literature and laboratory best practices.
By following ISO 13079:2011, laboratories and manufacturers ensure the quality and reliability of Westergren ESR tubes and related laboratory apparatus, fostering accurate clinical diagnostics and standardized medical laboratory procedures.
Open preview (PDF)Laboratory glass and plastics ware — Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method
