ISO 8655: General Requirements for Piston-Operated Volumetric Apparatus (POVA)
The ISO 8655 standard is an international standard for the calibration and testing of pipettes and other piston-operated volumetric apparatus (POVA), such as burettes, dilutors, dispensers, and syringes. The latest revision of ISO 8655 has ten parts, three more than the previous version, and includes stricter language about pipettes, maximum permissible errors, and user information. Pipette testing and calibration are addressed in Part 6, Part 7, and Part 8, with requirements for higher precision balances. Revised ISO 8655 aims to ensure reliable and reproducible pipetting accuracy in laboratories.
Whether you need a better understanding of the guidelines for in-house pipette calibration or for outsourcing services, it is important to know what these changes mean for you. Sartorius has decoded the standard and shares its expertise on the following topics.
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Arium® Advance EDI ensures consistent high-grade Type 2 deionized water. With a three-stage purification process, it effectively removes impurities from tap water.
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The precision of pipetting relies on your pipette and tip choice. Optifit standard and Safetyspace® Filter Tips are ideal for Sartorius pipettes, ensuring peak performance and result consistency.
Sartorius ensures precise, regulatory-compliant calibrations for liquid handling devices. Certificates guarantee tolerance adherence, offering clear, traceable results. Professional, easy-to-read reports with national standard traceability.
Ingenix Pipette Advanced Calibration Module simplifies pipette calibration workflow. ISO 8655 compliant, with network capabilities for secure data management.
Regular maintenance ensures pipette precision in lab applications. Smart weighing solutions for pipette calibration offer ISO 8655:2022 compliance, reducing errors, boosting efficiency, and cutting calibration costs.
The ISO 9001 certified Pipetting Academy Program guarantees knowledge and skills necessary for pipette users to meet quality requirements.in pipetting by Sartorius' certified trainers.
According to ISO 8655-6:2022, each channel shall be regarded as a single-channel. The paragraph 8.4.a details how a multi-channel balance can be used to measure all channels in parallel, aspirating and dispensing at the same time, one row at a time, and analyzing the results of each channel individually.Sartorius Speedcal mobile is a patented and unique pipette calibration system including up to 12 weighing systems to speed up precise and efficient calibration of pipettes up to 12 channels.
Learn More: Compliant multi-channel pipette calibration
To achieve professional pipette calibration according to ISO 8655-6:2022, the balance used for testing pipettes, burettes, dispensers or syringes shall be chosen according to minimum requirements, depending on the nominal volume of the apparatus under test. (see FAQ). In order to minimize the error due to evaporation, paragraph 7.3 specifies that the geometry of the weighing vessel should be considered.
Sartorius Cubis® MPS has been exclusively designed for pipette calibration, to reach the fastest stabilization times and the most ergonomic handling. Cubis® MPS features a draft shield with a motion sensor that opens automatically upon detecting the user, and closes automatically when the pipette is removed. This allows the user to focus on proper pipette handling.
Learn More: How to Perform a Norm Compliant Calibration or Test
With the recent update of ISO 8655, the calibration of pipettes requires balances of higher resolution with respect to the pipettes nominal volume. The new Pipette Calibration Kit YCP07MC includes an evaporation trap and 21 mL liquid reservoirs for Cubis® II Ultra-High Resolution Balances to keep the error due to evaporation as small as possible, without the need of an internal draft shield. It’s particularly recommended for small volumes <50 µL.
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In most laboratories, liquid handling products are utilized daily to prepare samples, controls, and assay reagents. Given that mechanical and electronic pipettes, as well as dispensers, are involved in almost every experiment, precision is of utmost importance.Sartorius offers certified and accredited services to ensure the accuracy of your laboratory results and the dependability of your pipetting devices. Our services can be conducted on-site or at one of our Sartorius calibration laboratories. We also provide services for devices from other pipette manufacturers.Sartorius’ services guarantee:
Learn More: Insights from Service Experts in ISO 8655:2022 Revision
The management of your pipette fleet with as-found and as-left calibrations requires the accuracy and precision values to be adapted to the nominal volume of the pipette, its environment or the number of channels. ISO 8655-6 paragraph 10 describes minimal information to be reported. The results of each test or calibration shall be reported accurately, unambiguously, and objectively.
Ingenix Pipette Advanced Calibration Module is the ideal software for service providers or for industries wishing to bring pipette calibration in-house.
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The ISO 8655-6 standard, paragraph 6, requires the use of distilled or deionized water conforming to grade 3 or better as specified in ISO 3696:1987 as test liquid.
The Arium® Advance EDI consistently provides high-quality Type 2 deionized water. Its triple-stage purification efficiently eliminates tap water impurities and contaminants.
In February 2024, ISO 8655 expanded with the addition of Part 10, providing detailed guidance on selecting Piston-Operated Volumetric Apparatus (POVA) and mastering pipetting techniques. This new section, ISO 8655-10, thoroughly outlines best practices for handling based on POVA type, liquid characteristics, pipetting methods, and other factors.
Gain essential pipetting skills, including correct techniques, maintenance, calibration, and ergonomic practices, through the high-quality training provided by the ISO 9001 certified Sartorius Pipetting Academy, ensuring laboratory personnel excel in their tasks and meet stringent quality standards.
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Master precision by exploring the implications of the ISO 8655:2022 standard, its most important changes and their impact on pipette users.
This resource guide offers a comprehensive toolkit for managing pipette calibration data, tracking, and scheduling, whether it's performed on- or off-...
The new ISO 8655:2022 standard impacts pipette calibration and testing labs. Our experts break down the changes for general and compliance lab users.
Most frequently asked questions about the new revised ISO 8655 standard.
This white paper presents the requirements for gravimetric calibration and testing of POVA according to ISO 8655:2022 Part 6 and Part 7.
This infographic describes the main points about ISO 8655:2022 Part 2.
Join our on-demand webinar for a detailed breakdown of ISO 8655 updates and their impact on pipette calibration, checking, testing, and related servic...
Ensure safe and reliable lab results with proper pipette calibration. Join our webinar to learn about ISO 8655 updates and Sartorius solutions for a f...
QApp pipette check offers a convenient solution for checking piston pipettes according to ISO 8655 Part 2
Learn about the importance of SOPs, maintenance, and calibration in regulated labs. This application note covers pipetting practices and tools for com...
Learn about the requirements for calibration of pipettes and POVA from a Sartorius expert.
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The balance used for testing shall be chosen according to the minimum requirements specified in the following table, depending on the nominal volume of the POVA under test.
Nominal volume of apparatus under test (V)
Resolution (d) mg
Repeatability (s) mg
0,5 μl ≤ V < 20 μl
0.001
0.006
20 μl ≤ V < 200 μl
0.01
0.025
200 μl ≤ V ≤ 10 ml
0.1
0.2
10 ml < V ≤ 1 000 ml
1
2
1 000 ml < V ≤ 2 000 ml
10
Sartorius Cubis II and MPS balances comply with these requirements.
Gravimetric Calibration and Testing of POVA According to Part 6 and 7 of the ISO 8655:2022
Calibration ensures pipettes dispense volumes accurately and precisely, adhering to GLP and ISO 8655 standards, and should match the specific pipette-tip combination used in the lab. Preventive maintenance involves cleaning, greasing, and part replacement to guarantee the pipette's longevity and reliable results.
ISO 8655 is an international standard that outlines requirements for pipette calibration, including environmental conditions, procedures, and equipment, ensuring reliable measurements. It provides guidelines for pipette characteristics, user and manufacturer responsibilities, and specifies testing equipment and procedures.
ISO 17025 is a standard that establishes the requirements for the competence of testing and calibration laboratories, ensuring the reliability and traceability of their measurements. Laboratories accredited to ISO 17025 undergo rigorous evaluations and annual audits, providing confidence in their calibration services and the accuracy of their issued certificates, which are recognized internationally through various accreditation bodies.
To establish a pipetting quality control program aligned with Good Laboratory Practice, create a Standard Operating Procedure (SOP) that includes:
All drug products have to be QC tested using robust methods that are appropriately qualified and validated under GxP conditions.
Quality Control in the biopharmaceutical industry includes the testing of raw materials, product intermediates and final drug products.
Every pharmaceutical manufacturer must demonstrate that their products are consistently manufactured, safe, potent, and pure.
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