CEN/TC 332/WG 1 - Glass and plastics devices including volumetric instruments

This document provides guidance and establishes requirements for collecting and examining volumetric performance data of automated liquid handling systems (ALHS). It specifies how to index and track volumetric performance data and provides descriptive statistics for the evaluation of these data. This document also specifies reporting requirements of ALHS volumetric performance.
This document is applicable to all ALHS with complete, installed liquid handling devices, including tips and other essential parts needed for delivering a specified volume, which perform liquid handling tasks without human intervention into labware.
NOTE       For terminology and general requirements of automated liquid handling systems, see ISO 23783-1. Measurement procedures for the determination of volumetric performance are given in ISO 23783-2.

This document specifies procedures for the determination of volumetric performance of automated liquid handling systems (ALHS), including traceability and estimations of measurement uncertainty of measurement results.
This document is applicable to all ALHS with complete, installed liquid handling devices, including tips and other essential parts needed for delivering a specified volume, which perform liquid handling tasks without human intervention into labware.
NOTE       For terminology and general requirements of automated liquid handling systems, see ISO 23783-1. Determination, specification, and reporting of volumetric performance of automated liquid handling systems is described in ISO 23783-3.

This document defines terms relating to automated liquid handling systems (ALHS). This document also specifies general requirements for the use of ALHS. It describes types of ALHS and specific use requirements, settings, and adjustments for each ALHS type. It also specifies environmental requirements for the use of ALHS.
This document is applicable to all ALHS with complete, installed liquid handling devices, including tips and other essential parts needed for delivering a specified volume, which perform liquid handling tasks without human intervention into labware.
NOTE       Measurement procedures for the determination of volumetric performance are given in ISO 23783-2. The determination, specification, and reporting of volumetric performance of automated liquid handling systems are described in ISO 23783-3.

This document specifies requirements and tests for glass Petri dishes intended for general laboratory purposes and microbiological work.

This document specifies requirements for borosilicate 3,3 glass tubing according to ISO 3585 for laboratory apparatus in an outer diameter range from 4 mm to 300 mm. This document defines dimensions, material, denomination, designation, requirements and inspection methods.

This document specifies
—    metrological requirements,
—    maximum permissible errors,
—    requirements for marking and
—    information to be provided for users,
for manually operated precision laboratory syringes made of glass or glass and metal designed to deliver their selected volume (Ex).
Manually operated precision laboratory syringes are instruments used for delivering liquids and gases. The barrel is typically made of glass and the plunger and the needle are typically made of metal.

This document specifies
—    metrological requirements,
—    maximum permissible errors,
—    requirements for marking and
—    information to be provided for users,
for burettes. This document is applicable to burettes with nominal volumes up to 100 ml, designed to deliver their specified volume (Ex).

This document specifies general requirements for piston-operated volumetric apparatus (POVA). It is applicable to pipettes, burettes, dilutors, dispensers and manually operated precision laboratory syringes. It furthermore defines terms for the use of piston-operated volumetric apparatus and gives user recommendations.
This document does not apply to medical products intended for use on humans, e.g. for medical syringes.

This document specifies the photometric reference measurement procedure for the determination of volume of piston-operated volumetric apparatus (POVA). The procedure is applicable to complete systems comprising the basic apparatus with a maximum nominal volume of 5 000 µl and all parts selected for use with the apparatus, disposable or reusable, involved in the measurement by delivery (Ex).

This document specifies
—    metrological requirements,
—    maximum permissible errors,
—    requirements for marking and
—    information to be provided for users,
for air-displacement (type A) and positive displacement (type D) single-channel and multi-channel pipettes, complete with their selected tip(s) and any other essential, consumable parts, designed to deliver the selected volume (Ex).

This document specifies
—    metrological requirements,
—    maximum permissible errors,
—    requirements for marking and
—    information to be provided for users,
for dispensers. It is applicable to dispensers with nominal volumes from 1 μl up to 200 ml, designed to deliver their volume (Ex).

This document specifies alternative measurement procedures for the determination of  volume of piston-operated volumetric apparatus.
The procedures are applicable to complete systems comprising the basic apparatus and all parts selected for use with the apparatus, disposable or reusable, involved in the measurement by delivery process (Ex). Methods described in this document are suitable for various maximum nominal volumes of piston-operated volumetric apparatus. It is the responsibility of the user to select the appropriate method.

This document specifies
—    metrological requirements,
—    maximum permissible errors,
—    requirements for marking and
—    information to be provided for users,
for dilutors with a sample uptake capacity (In) from 5 μl to 1 ml and a diluent capacity (Ex) from 50 μl to 100 ml. They are designed to deliver the sample and diluent together in measured proportion and measured volume.

This document specifies a gravimetric reference measurement procedure for the determination of volume of piston-operated volumetric apparatus (POVA). The procedure is applicable to complete systems comprising the basic apparatus and all parts selected for use with the apparatus, disposable or reusable, involved in the measurement by delivery (Ex) or contained (In).

ISO 16496:2016 recommends dimensions and specifies requirements and test methods for laboratory glassware manufactured from borosilicate glass 3.3 and provided with a vacuum jacket for thermal insulation. It covers Dewar vessels, vacuum-jacketed reaction vessels and vacuum-jacketed columns intended for laboratory use and laboratory related applications. Typical dimensions are given in Tables 1 to 5.
ISO 16496:2016 does not apply to large scale production equipment and equipment operated with pressures of more than 0,1 bar above atmospheric pressure.

ISO 4796-1:2016 specifies a series of screw-neck bottles suitable for the storage of fluid liquid and solid chemicals and reagents in general laboratory use. These bottles with nominal volumes ranging from 25 ml to 20 000 ml are also suitable for the preparation and storage of microbiological growth media.

ISO 3819:2015 specifies requirements for an internationally acceptable series of glass beakers for laboratory use.

ISO 384:2015 sets out principles for the design of volumetric instruments manufactured from glass or from plastics in order to facilitate the most reliable and convenient use to the intended degree of accuracy.

ISO 4797:2015 specifies requirements for an internationally acceptable series of boiling flasks with conical ground joints for general laboratory purposes.

ISO 6556:2012 specifies requirements to filter flasks with conical or cylindrical shape for general laboratory purposes.

ISO 13079:2011 specifies requirements for single-use and re-usable glass and plastics tubes for measuring the erythrocyte sedimentation rate (ESR) by the Westergren method, and for a support to hold tubes during the performance of the test. These so-called "Westergren tubes" are also sometimes designated as "Westergren pipettes". A procedure for measuring the erythrocyte sedimentation rate by the Westergren method is given in an informative annex.
ISO 13079:2011 does not apply to single-use containers for human venous blood specimen collection and their accessories for which other standards apply. It also does not apply for devices where the Westergren method has been used as basis to develop other, similar methods or equipment for the erythrocyte sedimentation rate determination.

ISO 13130:2011 specifies requirements and tests for desiccators and vacuum desiccators intended for general laboratory purposes such as drying of substances or material.

ISO 24998:2008 specifies requirements and test methods for plain, single-use Petri dishes for microbiological use.
ISO 24998:2008 does not apply to products of similar design which may be used for cell or tissue culture purposes. Neither does it apply to dishes supplied ready loaded with microbiological media.

ISO 648:2008 specifies metrological and constructional requirements for volumetric pipettes with one mark (total delivery) and for volumetric pipettes with two marks, both of which are adequate for general laboratory purposes.
The details specified are in conformity with the principles of design and construction of volumetric glassware given in ISO 384.

ISO 835:2007 specifies metrological and constructional requirements for graduated pipettes, adequate for general laboratory purposes.

This part of ISO 4796 specifies a series of aspirator bottles with a screw neck or with a conical neck suitable for the
delivery of liquid chemicals and reagents in general laboratory use.

This part of ISO 4796 specifies a series of bottles with a conical, wide or narrow neck with or without ground joints,
suitable for the storage of liquid and solid chemicals and reagents in general laboratory use.

Requirements for a series of one-mark volumetric flasks, suitable for the preparation of standard solutions.

ISO 13132:2011 specifies requirements and tests for glass Petri dishes intended for general laboratory purposes and microbiological work.

TC - Modifications in Foreword and in Clauses 1, 5, 7 and 8.

TC - Modifications in Foreword, in Clauses 1, 2 and 9 and in Subclause 8.3.

TC - Modifications in Foreword, Clauses 1 and 3, Annex A and Bibliography.

TC - Modification in Subclause 8.1.

TC - Modifications in Foreword and Clauses 1, 5, 7 and 8.

TC - Modifications in Foreword, Clause 1 and Subclauses 5.2.1, 8.1 and A.1.

TC - Modifications in Foreword, in Clauses 1, 7 and 8, in Subclause 5.1 and in Table 2.

ISO 8655-7:2005 specifies the photometric and titrimetric determination of errors of measurement of piston-operated volumetric apparatus. The tests are applicable to complete systems comprising the basic apparatus and all parts selected for use with the apparatus, disposable or reusable, involved in the measurement by delivery process.
These non-gravimetric test methods can be applied: as aids to quality assurance by the supplier; as routine quality assurance and routine calibrations by the user; and as routine and post-repair testing.
The methods described in ISO 8655-7:2005 are not applicable as alternatives to the gravimetric reference test methods specified in ISO 8655-6, which gives the only method suitable as a basis for supplier's declarations or independent certification of conformity.
NOTE 1 Metrological requirements for piston-operated volumetric apparatus, especially maximum permissible errors, are specified in ISO 8655-2 to ISO 8655-5.
NOTE 2 For conformity tests or type tests for declaration and certification of conformity, see the gravimetric reference test methods in ISO 8655-6.

ISO 8655-2:2002 specifies metrological requirements, maximum permissible errors, requirements for marking and information to be provided for users, for air-displacement (type A) and positive-displacement (type D) single-channel and multi-channel piston pipettes, complete with their selected tip(s) and any other essential, consumable parts, designed to deliver their specified nominal volume (Ex).

ISO 8655-4:2002 specifies metrological requirements, maximum permissible errors, requirements for marking and information to be provided for users, for dilutors with a sample uptake capacity (In) from 5 microlitres to 10 millilitres and a diluent capacity (Ex) from 50 microlitres to 100 millilitres. They are designed to deliver the sample and diluent together in measured proportion and measured volume.

ISO 8655-1:2002 specifies the general requirements for piston-operated volumetric apparatus. It is applicable to piston pipettes, piston burettes, dilutors and dispensers. It furthermore defines terms for the use of piston-operated volumetric apparatus and gives a list of equivalent terms. It also gives user recommendations.
ISO 8655-1:2002 is not applicable to medical products intended for use on human beings, e.g. for medical syringes.

ISO 8655-6:2002 specifies the gravimetric determination of errors of measurement for conformity testing of piston-operated volumetric apparatus. The tests are applicable to complete systems comprising the basic apparatus and all parts selected for use with the apparatus, disposable or reusable, involved in the measurement by uptake (In) or delivery (Ex) process.

ISO 8655-5:2002 specifies metrological requirements, maximum permissible errors, requirements for marking and information to be provided for users for dispensers. It is applicable to dispensers with nominal volumes from 1 microlitre up to 200 millilitres, designed to deliver their volume (Ex).

ISO 8655-3:2002 specifies metrological requirements, maximum permissible errors, requirements for marking and information to be provided for users, for piston burettes. It is applicable to piston burettes with nominal volumes up to 100 ml, designed to deliver their volume (Ex).

The standard specifies a series of bottles suitable for the storage of fluid liquid and solid chemicals and reagents in general laboratory use. These bottles are also suitable for the preparation and storage of microbiological growth media.

ISO 4797:2004 specifies requirements for an internationally acceptable series of boiling flasks with conical ground joints for general laboratory purposes.