It’s no secret pipettes and other liquid measuring tools are extremely crucial to a laboratory team. After all, the quality of your data is largely dependent on your pipette’s ability to dispense liquids accurately, precisely, and with reliable consistency. This is also why compliance auditors need proof that dispensing tools are in good working order and meet ISO 8655 requirements.
The ISO 8655 standard recently changed, and it’s been revised to better address how volumetric measuring devices are calibrated and checked to create greater accuracy and consistency across the industry. The new version of the standard is called ISO 8655:2022.
“The new standard is giving labs better direction and guidance in a way that will make volumetric measuring assets more reliable, more accurate, and better able to meet the quality assurance requirements they need to be both productive and extremely precise”
–Ryan Arnold, CEO, Qualer
What does this mean for laboratories who use, manufacture, or service these tools? That’s what we’re here to explain. In this article, you’re going to learn what the recent changes in the ISO 8655 standard are and how it will affect your laboratory.
Quick Recap: What is ISO 8655?
ISO 8655 is the standard within the International Organization for Standardization (ISO) database that pertains to piston-operated volumetric apparatus, or POVA, which includes pipettes, burettes, dilutors, syringes, and other liquid dispensing tools.
It includes standardized guidelines and requirements for the operation, calibration, manufacturing, and maintenance of POVA tools. ISO 8655 is a subset within the ISO 17025 that only addresses liquid handling devices and is considered the gold standard.
Laboratories that meet ISO 8655 requirements have demonstrated advanced expertise in liquid dispensing tools and their calibration which ensures they maintain the highest level of reliability and consistency when measuring liquids and servicing POVA tools.
Not every lab needs to meet these strict standards, but many do. Examples of those that do include:
- Commercial calibration laboratories
- POVA manufacturers
- Labs that handle calibration services in-house
- GMP manufacturers
- Clinical research facilities
- Any lab whose clients require ISO 8655 standards as a contractual obligation
Explaining the Details of the New ISO 8655:2022 Standard
So, what’s really changed from the old standard to the new one? For starters, there are now nine parts to the standard, two more than the previous one. Let’s explore each part to understand the rest.
ISO 8655-1: General Requirements
ISO 8665-1 denotes the terminology, general requirements, and user recommendations of the standard in entirety. It is applicable to pipettes, burettes, dilutors, dispensers and manually operated precision laboratory syringes.
ISO 8655-2: Pipette
The ISO 8655-2 section defines the following for pipettes:
- Maximum permissible error limits
- Marking requirements
- What information pipette manufacturers must provide to users
It includes definitions and specifications for multi and single-channel pipettes, air-displacement pipettes as well as positive displacement pipettes. One truly notable addition to the standard as it considers the pipette; the pipette and the tip are now combined as one system.
ISO 8665-3: Burettes
Piston burettes, primarily used for titration and other applications for timed or metered deliveries of liquid, are the focus of ISO 8655-3. This also defines error limitations, marking requirements and manufacturer information to be included with a product and user information, similar to ISO 8655-2.
ISO 8655-4 and ISO 8655-5: Dilutors and Dispensers
These two sections cover the guidelines and specifications regarding dilutors and liquid dispensers. As with part 2 and 3, it outlines the specifications, tolerance, error limitations, and other asset specific considerations.
ISO 8655-6: Gravimetric Reference Measurement Procedure for the Determination of Volume
In more simple terms, ISO 8655-6 defines the guidelines on how the accuracy of POVA tools using gravimetric measurements is to be assessed. This section (as well as 7 and 8, which will be discussed below) can be viewed as the real meat of the standard as it outlines the requirements to adhere to in the calibration of volumetric measuring instruments.
Notable improvements in the standard found in ISO 8655-6 include:
- A minimum of ten measurements per volume must be made for at least three volumes, including at 100%, 50%, and 10% of the nominal volume, for every POVA device calibration is now required.
- There must be at least one tip change during the process.
- Increase in environmental conditions monitoring.
- Pipettes can be tested against performance specifications other than ISO, but they must be more stringent than the ISO one.
- Better analytical balances are required.
ISO 8655-7: Alternative Measurement Procedures for the Determination of Volume
A limitation of the original ISO 8655 standard was it only allowed gravimetric measurements and specific environmental conditions for determining volume when calibrating POVA tools. However, it’s not always possible to create such strict environmental controls or to rely solely on gravimetric testing procedures.
The updated standard has addressed these limitations and provided alternatives in ISO 8655-7.
ISO 8655-8: Photometric Reference Measurement Procedure for the Determination of Volume
Another impactful change to the standard, which is outlined in ISO 8655-8, is that photometric measurements are an approved measurement method when determining the volume delivery accuracy of a POVA tool.
This means laboratories can also use photometric measurement techniques in order to comply with ISO 8655 in addition to gravimetric ones.
The requirements, guidelines, and limitations when using photometric measurements to evaluate and calibrate POVA instruments is outlined in ISO 8665-8.
ISO 8655-9: Manually Operated Precision Laboratory Syringes
Manually operated laboratory syringes were previously excluded from the original standard. The new version has rectified that oversight by adding information and guidelines pertaining to this type of volumetric measuring device.
As with other parts that address different POVA tools, part nine provides maximum permissible errors, design requirements, and terminology definitions specific for syringes.
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Moving Forward: How Will the New ISO 8655 Specifications Affect Labs?
There are a lot of new and exciting changes in the new ISO 8655 standard that are going to help make liquid measurement more accurate and consistent around the world. For those that rely on these measurements every day to produce reliable results, these changes should be welcome, good news.
Six examples of how the new standard will improve are:
- Increased Emphasis on User Training: One of the notable changes in the 2022 revision of ISO 8655 is the increased emphasis on user training. It now requires users to adhere to manufacturer instructions and to consider the pipette and pipette tip as a standalone system.
- Enhanced Calibration Procedures: The updated standard provides more detailed guidance on calibration procedures to ensure that the POVA tool aligns with the manufacturers guidelines and acceptance limits. The inclusion of more measurement methods will give labs greater flexibility when meeting the new standard.
- Inclusion of Digital Pipettes: Digital pipettes have become more prevalent in laboratories. The 2022 revision of ISO 8655 now incorporates guidelines related to the use and calibration of digital pipettes.
- Clarification on Maintenance and Cleaning: The revised standard offers clearer instructions on how users at every level should perform maintenance and cleaning tasks of piston-operated volumetric apparatus. This will help retain an asset’s integrity and functionality for longer.
- Allows for Two Measurement Procedures: Photometric measurement procedures are now considered equal to gravimetric measuring procedures for calibration and checking of POVA tools. The ISO 8655:2022 does not favor one over the other.
- Broader Scope: The revised standard has a broader scope, covering more types of piston-operated volumetric apparatus. This ensures that a wider range of equipment adheres to the same high standards of accuracy and reliability.
Meet ISO 8655 Requirements More Easily with Qualer’s Asset Management Software Solutions
While the new version of ISO 8655 will help make our liquid measuring assets perform better and create more reliable results, it will require more data collection from laboratories.
Increased measurements numbers, stricter tolerances, improved environmental monitoring, as well as other factors, will require labs to collect more data than before. As a result, teams will need to take a more thorough approach to managing asset data.
Qualer’s advanced CMMS can help ease this burden and even streamline a lab’s asset calibration and management program. Built by industry experts with over 30 years of lab experience, it’s a solution that is designed specifically for laboratory settings and can help you achieve compliance with ISO 8655 and other standards.
To learn more about how Qualer can help you meet the new ISO 8655:2022 requirements for your lab, contact our team today.