1、 ISO 2015 Specification and method for the determination of performance of automated liquid handling systems Spcification et mthode pour la dtermination de performance des systmes automatiss de manipulation de liquides INTERNATIONAL WORKSHOP AGREEMENT IWA 15 First edition 2015-10-15 Reference number
2、 IWA 15:2015(E) IWA 15:2015(E)ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, in
3、cluding photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerlan
4、d Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org IWA 15:2015(E)Foreword v 1 Scope .1 2 Normative references 1 3 Terms and definitions .1 3.1 Definitions . 2 3.2 Abbreviated terms . 8 4 Operation of automated liquid handling systems 9 4.1 Types of automated liquid handling sy
5、stems . 9 4.1.1 Types of piston operated automated liquid handling systems 9 4.1.2 Types of other (pump operated) automated liquid handling systems 9 4.2 Adjustment 10 4.2.1 Need for adjustment 10 4.2.2 Liquid classes .10 4.2.3 Adjustment of ALHS settings 10 4.3 Tips .10 4.3.1 General.10 4.3.2 Air-d
6、isplacement tips .10 4.3.3 Positive displacement tips 11 4.3.4 Fixed tips11 4.4 Environmental conditions 11 4.4.1 Discussion and recommendations.11 4.4.2 Factory acceptance testing .11 4.4.3 Site acceptance and user testing .12 5 Volumetric performance .12 5.1 Introductory discussion .12 5.2 Data co
7、llection and examination 14 5.3 Indexing to track data 15 5.3.1 Indexing from the channel perspective .15 5.3.2 Indexing from the microplate perspective .15 5.4 Descriptive statistics on an individual channel basis .16 5.5 Descriptive statistics on a run order basis .18 5.6 Descriptive statistics fo
8、r entire data sets 18 5.7 Differences between channels 19 5.8 Handling of sub-deliveries .19 6 Measurement methods .20 6.1 Overview of methods suitable for measuring ALHS performance 20 6.2 Methods for use with any ALHS platform (open methods) .29 6.2.1 Ratiometric photometry .29 6.2.2 Gravimetry, s
9、ingle channel measurement .29 6.2.3 Gravimetry, full-plate measurement for correlation with photometry .29 6.2.4 Gravimetric regression method for low volumes .30 6.2.5 Photometry using Orange G 30 6.2.6 Hybrid method: gravimetry and photometry with Tartrazine 30 6.2.7 Hybrid method: photometry and
10、gravimetry with p-nitrophenol 31 6.2.8 Hybrid method: gravimetry and photometry with Ponceau S 31 6.2.9 Pressure sensing .31 6.2.10 Calorimetric measurement 31 6.2.11 Optical image analysis 31 6.3 Methods specific to an ALHS model or accessory (closed methods) 32 6.3.1 Gravimetry and hybrid method:
11、gravimetry and photometry 32 6.3.2 Photometry with Tartrazine .32 7 Specification of ALHS volumetric performance 33 ISO 2015 All rights reserved iii Contents Page IWA 15:2015(E)7.1 Mandatory information to be supplied by manufacturer .33 7.2 Optional information that can be supplied by manufacturer
12、33 8 Reporting .34 8.1 Reporting the results 34 8.1.1 General.34 8.1.2 Test reports and calibration certificates 34 8.1.3 Calibration certificates.35 9 Potential future work .36 Annex A (informative) Applications of descriptive statistics .38 Annex B (informative) Test methods for ALHS performance .
13、50 Annex C (normative) Calculation of liquid volumes from balance readings 114 Annex D (informative) Workshop contributors 116 Bibliography .117 iv ISO 2015 All rights reserved IWA 15:2015(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national stan
14、dards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International org
15、anizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for it
16、s further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/di
17、rectives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in
18、the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions re
19、lated to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TMBG, Technical Management Board Groups. ISO 2015
20、All rights reserved v Specification and method for the determination of performance of automated liquid handling systems 1 Scope This International Workshop Agreement (IWA) specifies methods for testing the volumetric performance of air-displacement, system-liquid filled and positive displacement au
21、tomated liquid handling systems (ALHS), including an estimation of measurement uncertainties and established traceability to reference standards (preferably, traceability to SI Units). The testing methods specified in this document may also be used to measure the volumetric performance of automated
22、liquid delivery systems which do not aspirate the test liquid. This IWA also specifies statistical methods for the determination of random and systematic errors (including intra-plate and inter-plate comparisons), analysis of measured results when using multichannel dispensing heads, and analysis de
23、pending on dispense patterns. It further defines terms and formulae to be used for summarizing test results. This IWA also specifies the information to be provided to users of ALHS, including the display of summary results and performance claims. This IWA is applicable to all ALHS with complete, ins
24、talled liquid handling devices, including tips and other essential parts needed for delivering a specified volume, which perform liquid handling tasks without human intervention into microplates. Manipulation of the microplates on the deck of the automated liquid handling system may be achieved auto
25、matically, semi-automatically, or manually. This IWA addresses the needs of: suppliers of ALHS, as a basis for quality control including, where appropriate, the issuance of suppliers declarations; test houses and other bodies, as a basis for independent certification and calibration; users of the eq
26、uipment, to enable calibration, verification, validation, and routine testing of trueness and precision. The tests established in this IWA should be carried out by trained personnel. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and
27、are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories 3 Term
28、s and definitions For purposes of this document, the following terms and definitions apply. International Workshop Agreement IWA 15:2015(E) ISO 2015 All rights reserved 1 IWA 15:2015(E) 3.1 Definitions 3.1.1 accuracycloseness of agreement between a delivered volume and the target volume Note 1 to en
29、try: The concept accuracy is not a quantity and is not given a numerical quantity value. A liquid delivery is said to be more accurate when it is accomplished with a smaller liquid handling error. SOURCE: ISO/IEC Guide 99:2007, 2.13, modified 3.1.2 air displacement liquid handling principle in which
30、 a body of air is contained between the piston and the test liquid Note 1 to entry: It is possible to have a large air gap (piston systems), or smaller air gap between the test liquid and the system liquid (liquid filled systems). 3.1.3 ALHS uncertainty non-negative parameter characterizing the disp
31、ersion of the measured volumes relative to the target volume Note 1 to entry: Uncertainty is inversely related to accuracy, and is a quantity value. This value should be expressed in accordance with ISO/IEC Guide 98-3. SOURCE: ISO/IEC Guide 99:2007, 2.26, modified 3.1.4 aliquotsingle delivery during
32、 a multi-dispense 3.1.5 automated liquid handling system ALHS system with a complete, installed liquid handling device, including tips and other essential parts needed for delivering a specified volume without human intervention into microplates Note 1 to entry: Examples of automated liquid handling
33、 systems include automated pipetting systems (APS), and automated dispensing systems (ADS). 3.1.6 calibrationoperation that, under specified conditions, establishes a relation between the target volume of the ALHS and the delivered volume Note 1 to entry: A calibration may be expressed by a statemen
34、t, a calibration curve or a calibration table. It may include a correction, but correction or adjustment is not a required element of a calibration. SOURCE: ISO/IEC Guide 99:2007, 2.39, modified 3.1.7 dead air volume captive air volume air gapair volume between the lower part of the piston and the s
35、urface of the aspirated liquid Note 1 to entry: It is possible to have a large air gap (piston systems), or smaller air gap for liquid filled systems. Sometimes called captive air volume.2 ISO 2015 All rights reserved IWA 15:2015(E) Note 2 to entry: Commonly, an air gap can be adjusted through ALHS
36、system parameters, while the dead air volume or captive air volume cannot be adjusted (see 4.2.1). 3.1.8 delivered volume quantity delivered by a liquid handling system Note 1 to entry: Delivered volume is a conceptual term and cannot be known with complete certainty due to measurement error. 3.1.9
37、dispense height height at which the test liquid is dispensed relative to a stated reference 3.1.10 dispensing system system for delivering liquids from a pre-filled liquid reservoir 3.1.11 disposable tip tip, which is attached once and after use, as defined by the manufacturer, detached and intended
38、 to be discarded Note 1 to entry: Disposable tips are usually made of plastic. Note 2 to entry: Disposable tips are in contrast to fixed tips, which are described in 4.3.4. 3.1.12 dry contact dispensing dispensing of liquid while tip is in contact with the dry target 3.1.13 factory acceptance testin
39、g internal vendor testing to ensure ALHS performance to specifications 3.1.14 forward mode pipetting direct mode pipetting pipetting mode where the entire aspirated volume is delivered 3.1.15 immersion depth depth of the tip below the liquid surface Note 1 to entry: Immersion depth can be applied to
40、 both aspiration and dispensing (wet contact). SOURCE: Toolpoint Photometric Volume Check Procedure:2008, modified 3.1.16 individually controlled channel liquid handling channel that can be operated independently of other channels 3.1.17 labwarematerials used in conjunction with liquid handling oper
41、ations Note 1 to entry: Labware includes disposable tips, reservoirs, receiving vessels, adapters and microplates. 3.1.18 maximum permissible error upper or lower permitted extreme value for the deviation of the dispensed volume from the target volume ISO 2015 All rights reserved 3 IWA 15:2015(E) 3.
42、1.19 maximum specified volume largest volume for which the manufacturer offers specifications Note 1 to entry: The maximum specified volume may vary depending on instrument configuration (e.g. disposable tip size, syringe size). 3.1.20 measured volume quantity reported by a volume measuring system N
43、ote 1 to entry: In practice, all measurements contain some measurement error. The measured volume is a quantity value and serves as an estimate of the delivered volume which is not known with complete certainty. 3.1.21 measurement method measurement procedure detailed description of a measurement ac
44、cording to one or more measurement principles Note 1 to entry: The source document (ISO/IEC Guide 99) draws a distinction between measurement method and measurement procedure and that distinction is ignored here. In this IWA, the terms are used interchangeably. Note 2 to entry: The measurement metho
45、d descriptions in this IWA detail the steps needed to make a volume measurement and calculate certain descriptive statistics. Additional details needed to operate the ALHS are part of the test process as defined in 3.1.43. In this IWA, the measurement method is one of the components of a test proces
46、s. SOURCE: ISO/IEC Guide 99:2007, 2.6, modified 3.1.22 measurement uncertaintynon-negative parameter characterizing the dispersion of the measured volumes relative to the delivered volume Note 1 to entry: Uncertainty is inversely related to accuracy, and is a quantity value. This value should be exp
47、ressed in accordance with the ISO/IEC Guide 98-3. SOURCE: ISO/IEC Guide 99:2007, 2.26, modified 3.1.23 metrological traceability property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement
48、 uncertainty Note 1 to entry: Additional information can be found in the notes to definition (ISO/IEC Guide 99:2007, 2.41) and the related term metrological traceability chain (ISO/IEC Guide 99:2007, 2.42). SOURCE: ISO/IEC Guide 99:2007, 2.41 3.1.24 microplate flat plate with an array of wells Note
49、1 to entry: Some dimensions of microplates are defined in ANSI/SLAS standards. 1-5 3.1.25 minimum specified volume smallest volume for which the manufacturer offers specifications Note 1 to entry: The minimum specified volume may vary depending on instrument configuration.4 ISO 2015 All rights reserved IWA 15:2015(E) 3.1.26 multichannel head group of liquid handling channels operated in common Note 1 to entry: Common arrangements of multichannel heads include 8, 96, 384, and 1536 channel heads. Other arrangements ar
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