Introduction to SN EN ISO 8655-2:2022 - Pipettes

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What SN EN ISO 8655-2:2022 covers

The standard specifies metrological requirements for air-displacement and positive displacement pipettes, both single-channel and multi-channel, including their selected tips and necessary consumable parts. It also defines maximum permissible errors in measurements, marking requirements, and essential user information. Importantly, the standard clarifies the boundaries of its scope, indicating that it applies specifically to pipettes designed to deliver selected volumes but does not cover devices outside this category, such as automated liquid handlers or non-piston devices.

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Who needs to comply with SN EN ISO 8655-2:2022

The primary audience for SN EN ISO 8655-2:2022 includes manufacturers of pipettes, laboratories specializing in metrology, quality control professionals, and end-users in various industries such as pharmaceuticals, biotechnology, and academic research. Compliance is crucial for organizations ranging from small laboratories to large-scale production facilities, as it helps maintain accuracy in liquid measurement processes and ensures adherence to regulatory requirements within the Metrology & Measurement sector.

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Key requirements

• Metrological Requirements: Establishes criteria for measuring accuracy and precision in pipette performance.
• Maximum Permissible Errors: Outlines the acceptable error limits for pipette measurements to ensure reliability.
• Labeling Requirements: Specifies necessary markings on pipettes to provide essential information to users.
• User Information: Details the information that must be provided to users for proper pipette operation and maintenance.
• Calibration Procedures: Includes directives for the calibration of pipettes to maintain compliance with the standard.

These requirements are typically audited through regular quality assurance processes and performance evaluations within laboratories and manufacturing settings.

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How to implement SN EN ISO 8655-2:2022

Implementing SN EN ISO 8655-2:2022 involves several key steps. First, conduct a gap analysis to identify areas needing improvement to meet the standard's requirements. Next, develop appropriate documentation that outlines processes and procedures in compliance with the standard. Training sessions should be organized for staff to ensure understanding and proper application of the requirements. Following this, an internal audit should be carried out to assess compliance before undergoing a certification audit by an external body. This structured approach helps organizations systematically integrate the standard into their operations and maintain quality control.

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Related standards

• ISO 8655-1: Provides general requirements for piston-operated volumetric apparatus, serving as a foundational document for SN EN ISO 8655-2:2022.
• ISO 6789: Specifies requirements for torque tools, which can be relevant in the context of ensuring proper assembly and maintenance of pipettes.
• ISO 17025: Relates to the competence of testing and calibration laboratories, crucial for laboratories using pipettes in their procedures.
• ISO 9001: Focuses on quality management systems and is complementary in ensuring overall quality compliance for organizations that manufacture or use pipettes.

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Why SN EN ISO 8655-2:2022 matters

Adhering to SN EN ISO 8655-2:2022 provides significant business advantages, including enhanced competitive edge, improved legal compliance, and access to international markets. It fosters customer trust through demonstrated commitment to quality and accuracy in liquid measurement. Organizations are encouraged to explore training and purchasing options to support their compliance efforts below.