WHO/PQS/E06/TR05.
1
PQS performance specification Original: English
Distribution: General
TITLE: User-programmable temperature data loggers
Specification reference: E06/TR05.1
Product verification protocol: E06/TR05.VP.1
Date of origin: 30 November 2006
Date of last revision: New specification
Contents:
1. Scope: ......................................................................................................................... 2
2. Normative references: .............................................................................................. 2
3. Terms and definitions:.............................................................................................. 2
4. Requirements: ........................................................................................................... 3
4.2 Performance: ....................................................................................................... 3
4.2.1 Operating temperature range:.................................................................... 3
4.2.2 Accuracy: .................................................................................................... 3
4.2.3 Resolution: .................................................................................................. 3
4.2.4 Power source: ............................................................................................. 3
4.2.5 Sensor: ........................................................................................................ 3
4.2.6 Memory:...................................................................................................... 3
4.2.7 Product response time: ............................................................................... 3
4.2.8 Unit of measurement:.................................................................................. 3
4.2.9 Calibration:................................................................................................. 3
4.2.10 Logging interval: ........................................................................................ 3
4.2.11 Logging start delay:.................................................................................... 3
4.2.12 Alarm settings: ............................................................................................ 3
4.2.13 Casing:........................................................................................................ 3
4.2.14 IP rating:..................................................................................................... 3
4.2.15 Battery: ....................................................................................................... 3
4.2.16 Electromagnetic compatibility:................................................................... 3
4.2.17 Data connection leads: ............................................................................... 3
4.2.18 Software: ..................................................................................................... 3
4.3 Environmental requirements:.............................................................................. 3
4.3.1 Ambient temperature range during transport, storage and use: ................ 3
4.3.2 Ambient humidity range during transport, storage and use:...................... 3
4.3.3 Resistance to electrical storms: .................................................................. 3
4.3.4 Impact resistance:....................................................................................... 3
4.3.5 Vibration:.................................................................................................... 3
4.4 Physical characteristics: ...................................................................................... 3
4.4.1 Overall dimensions: .................................................................................... 3
4.4.2 Weight:........................................................................................................ 3
4.5 Interface requirements: ....................................................................................... 3
4.5.1 Software compatibility:............................................................................... 3
4.6 Human factors:.................................................................................................... 3
4.6.1 Activation:................................................................................................... 3
4.6.2 De-activation: ............................................................................................. 3
4.6.3 User interface: ............................................................................................ 3
4.6.4 Mounting device: ........................................................................................ 3
WHO/PQS/E06/TR05.1 1 of 8 30 November 2006
4.6.5 Audible alarm: ............................................................................................ 3
4.7 Materials: ............................................................................................................ 3
4.7.1 Ozone depleting chemicals: ........................................................................ 3
4.7.2 Other restricted materials: ......................................................................... 3
4.8 Warranty: ............................................................................................................ 3
4.9 Servicing provision: ............................................................................................ 3
4.10 Disposal and recycling:....................................................................................... 3
4.11 Instructions:......................................................................................................... 3
4.12 Training:.............................................................................................................. 3
4.13 Verification: ........................................................................................................ 3
6. On-site installation:................................................................................................... 3
7. Product dossier: ........................................................................................................ 3
8. On-site maintenance: ................................................................................................ 3
9. Change notification:.................................................................................................. 3
10. Defect reporting: ....................................................................................................... 3
1. Scope:
This specification describes the performance requirements for user-
programmable electronic temperature data loggers to be used for study and
commissioning purposes throughout the vaccine cold chain.
2. Normative references:
EMAS: European Union Eco-Management and Audit Scheme.
EN 12830:1999: Temperature recorders for the transport, storage and
distribution of chilled, frozen, deep-frozen/quick-frozen food and ice cream.
Tests, performance and suitability.
European Union Directive 2002/96/EC: Waste Electrical and Electronic
Equipment.
IEC 60529: Consolidated Edition 2.1 (incl. am1): Degrees of protection
provided by enclosures (IP Code).
ISO 9001: 2000: Quality Management Systems – Requirements.
ISO 14001: 2004: Environmental management systems - Requirements with
guidance for use.
ISO/IEC 17025: 2005: General requirements for the competence of testing
and calibration laboratories.
3. Terms and definitions:
EPROM: Electrically erasable, programmable, read-only memory.
In writing: means communication by letter, fax or email.
LCD: Liquid Crystal Display.
LED: Light-Emitting Diode.
Legal Manufacturer: The natural or legal person with responsibility for the
design, manufacture, packaging and labeling of a product or device before it is
placed on the market under his own name, regardless of whether these
operations are carried out by that person himself or on his behalf by a third
party.
Montreal Protocol: Montreal Protocol on Substances that Deplete the Ozone
Layer.
NIST: United States National Institute of Standards and Technology.
WHO/PQS/E06/TR05.1 2 of 8 30 November 2006
Operating life: In relation to replaceable batteries is the period following initial
activation of the device. In the case of devices with non-replaceable batteries
the period is measured from the date of delivery to the purchaser, regardless of
whether the device is activated on that date.
Reseller: A commercial entity, licensed to act on behalf of a Legal
Manufacturer, and which carries product liability and warranty responsibilities
no less onerous than those carried by the Legal Manufacturer.
4. Requirements:
4.1 General: User-programmable electronic temperature data loggers to be used
for study and commissioning purposes throughout the vaccine cold chain.
Devices with replaceable and non-replaceable batteries, with or without
external sensor leads are included.
4.2 Performance:
4.2.1 Operating temperature range:
Upper limit: +55°C.
Lower limit: -30°C.
The logger electronics must function over the entire operating temperature
range, with or without optional probes.
4.2.2 Accuracy: Accuracy: ±0.5°C or better within the range -20°C to +20°C for a
minimum of 12 months following initial calibration or subsequent re-
calibration. ±1.0°C or better after 12 months if re-calibration is not carried
out.
4.2.3 Resolution: ±0.2°C or better within the range -30°C to +20°C.
4.2.4 Power source: Replaceable or non-replaceable battery.
4.2.5 Sensor: Devices with internal and/or external sensors will be considered1.
• Internal sensor: Electronic.
• External sensor: Electronic exposed junction device with lead(s) up to 10
metres long. Devices offering more than one external sensor connection
will not be excluded.
4.2.6 Memory: EPROM or equivalent non-volatile solid-state memory device
capable of storing a minimum of 1920 temperature readings per sensor. Some
applications will require devices with a larger memory.
4.2.7 Product response time: T90 20 minutes maximum in accordance with
EN12830:1999.
4.2.8 Unit of measurement: Temperatures must be recorded in degrees Centigrade.
A Fahrenheit scale is not required; however products with an optional
Fahrenheit scale are acceptable.
4.2.9 Calibration: Each product is to be covered by a Certificate of Traceability and
Calibration. The traceability declaration is to confirm that the measurement
standards and instruments used during calibration of the product are traceable
to an ISO/IEC 17025 accredited testing laboratory, to NIST, or to another
internationally recognized standards agency. The certificate must be
accompanied by a copy of the reference instrument calibration certificate.
1
Devices with external sensors may be required for monitoring temperatures at more than one point at
a time and for monitoring temperatures in vaccine freezer rooms and freezers where battery and/or
LCD performance may be adversely affected.
WHO/PQS/E06/TR05.1 3 of 8 30 November 2006
4.2.10 Logging interval: The user must be able to program the logging interval at
equal intervals between one minute and one hour. Products with a wider range
of logging intervals will be acceptable.
4.2.11 Logging start delay: The user must be able to program a logging start delay
between 0 seconds and 30 days. Products allowing a programmable delay
greater than 30 days will be acceptable.
4.2.12 Alarm settings:
• User programmable upper and lower alarm temperatures and alarm time
delays at any temperature in the operating temperature range.
• User programmable cumulative exposure facility for at least one upper
temperature setting and one lower temperature setting.
4.2.13 Casing: Non-corrodible plastics or metal case.
4.2.14 IP rating: Protection of the product not less than IEC 60529: IP54 for devices
with replaceable batteries and IP65 for devices with non-replaceable batteries.
4.2.15 Battery:
• EITHER: Replaceable battery with a minimum operating life of one year.
• OR: Non-replaceable battery with a minimum operating life of one year.
4.2.16 Electromagnetic compatibility: Operation of the device must be unaffected in
the normal electromagnetic compatibility environment in which it is intended
to work, taking into account disturbance generated by adjacent apparatus
which is compliant with relevant ISO, EN, or other internationally recognized
standards. Information required to ensure uninterrupted use of the device must
be contained in the user instructions.
4.2.17 Data connection leads: The product must include an RS232 or USB
connection lead for linking the device to a PC OR the link between the product
and the lead may be via a product-specific reader, provided the reader is an
integral part of the cable assembly.
4.2.18 Software: The data link must be supplied with software on CD or USB stick –
refer also to clauses 4.5 and 4.11. Downloadable software is not acceptable
because of poor or absent internet connections in many user settings.
As a minimum, the software must be capable of the following tasks:
• Allow the user to program the product to:
- set the time zone at initialization either manually or automatically;
- record user name and job description data;
- set a logging start delay;
- set a logging interval;
- set upper and lower single exposure and cumulative exposure
temperature alarm and delay conditions;
- set the product to stop when the memory is full, or to overwrite data
cyclically on a first-in-first-out basis;
- batch program more than one logger with the same set-up data.
• Output downloaded data in the form of temperature graphs and data tables
to:
- show time periods in seconds, minutes, hours or days to suit the
programmed logging interval;
- show temperatures in degrees centigrade;
- clearly show the programmed alarm settings;
- show the time zone set by the user;
- show the data logger serial number and/or user-set tracking number;
WHO/PQS/E06/TR05.1 4 of 8 30 November 2006
- show user description data;
- show statistics, including minimum and maximum temperatures, average
temperatures, cumulative time out of range, etc.
- the ability to show a composite view of data recorded on multiple data
loggers is desirable but not mandatory.
- print legibly in A4 format on a monochrome printer.
• Save logger data to a PC.
• Multilingual software, in the languages specified in clause 4.11, is
desirable, but not mandatory.
4.3 Environmental requirements:
4.3.1 Ambient temperature range during transport, storage and use: -30°C to
+55°C
4.3.2 Ambient humidity range during transport, storage and use: 0 to 95% RH.
4.3.3 Resistance to electrical storms: The functionality of the device must not be
affected by intense electrical storm activity.
4.3.4 Impact resistance: Product to withstand 5 drops from 1 metre onto a concrete
floor, with battery in place, without physical damage or loss of calibration.
4.3.5 Vibration: Product to withstand 30 minutes on a programmable vibrating table
without physical damage or loss of calibration.
4.4 Physical characteristics:
4.4.1 Overall dimensions: Not exceeding 100 x 75 x 50mm, excluding data
connection lead and any external sensors.
4.4.2 Weight: Not critical, provided the product is fully portable.
4.5 Interface requirements:
4.5.1 Software compatibility:
• If the software requires an interface with a proprietary spreadsheet
program, the list of compatible programs must include all releases of
Microsoft Excel currently supported by Microsoft.
• The software must be compatible with all Microsoft PC operating systems
currently supported by Microsoft.
4.6 Human factors:
4.6.1 Activation: The product may be activated, either by means of a button or
switch mounted on the unit, or by software command.
4.6.2 De-activation: It should not be possible to de-activate the product
inadvertently or deliberately at any time within the logging period, except by
software command or by means of a pin-operated switch.
4.6.3 User interface:
Products with LED indicator(s) only: The product is to have a minimum of
one indicator light. The indicator or indicators must provide the user with the
following information by means of combinations of steady or flashing lights:
• that the product is activated;
• that the battery is functioning;
• whether the temperature of the load has remained within alarm limits since
recording commenced,
OR;
• whether the temperature of the load has strayed outside alarm limits since
recording commenced.
WHO/PQS/E06/TR05.1 5 of 8 30 November 2006
Products with LCD displays: The product is to have an LCD display, with or
without LEDs, capable of showing the following information:
• that the product is activated;
• that the battery is functioning;
• the most recently recorded load temperature;
• whether the temperature of the load has remained within alarm limits since
recording commenced,
OR;
• whether the temperature of the load has strayed outside alarm limits since
recording commenced.
• The LCD may show all this information together on the display or the user
may be required to access the information by means of a button mounted on
the product. Products with more than one sensor must be able to show
temperature and alarm data from all connected sensors.
4.6.4 Mounting device: Although this is not a mandatory requirement, a means to
physically secure the device to the load is desirable. Acceptable options
include, but are not confined to:
• Fixing eye for tie.
• Double-sided tape.
• Mounting cleat.
4.6.5 Audible alarm: Not required.
4.7 Materials:
4.7.1 Ozone depleting chemicals: During manufacture and assembly of the printed
circuit boards and final assembly of the product do not use any substance
included in Annex A, B or C of the Montreal Protocol.
4.7.2 Other restricted materials: The product and its constituent components,
including batteries, must not contain lead, mercury, cadmium, hexavalent
chromium, polybrominated biphenyls (PBB) or polybrominated biphenyl
ethers (PBDE).
4.8 Warranty: The product is to be covered by a one year warranty in the event of
any component failure not caused by mechanical damage.
4.9 Servicing provision: The product is to be maintenance-free, apart from routine
battery replacement and re-calibration.
4.10 Disposal and recycling: The manufacturer is to provide information to the
buyer on the hazardous materials contained within the system and suggestions
for resource recovery/recycling and/or environmentally safe disposal. For the
European Union WEEE compliance in accordance with European Union
Directive 2002/96/EC is mandatory.
4.11 Instructions: User instructions, including software manual, in Arabic, English,
French, Mandarin Chinese, Russian and Spanish. The manual may be in hard
copy format or supplied with the software on CD.
4.12 Training: No requirement.
4.13 Verification: In accordance with PQS Verification Protocol E06/TR05.VP.1
WHO/PQS/E06/TR05.1 6 of 8 30 November 2006
5. Packaging:
Materials used for packaging the finished product are to be free of ozone-
depleting compounds as defined in the Montreal Protocol.
6. On-site installation:
Not applicable.
7. Product dossier:
The legal manufacturer or reseller is to provide WHO with a pre-qualification
dossier containing the following:
• Dossier examination fee in US dollars.
• General information about the legal manufacturer, including name and
address.
• Confirmation of the brand name of the product.
• Full specifications of the product being offered, covering all the
requirements set out in this document, including details of product marking
and traceability.
• Certified photocopy of Certificate of Traceability and Calibration traceable
to an ISO/IEC 17025 accredited testing laboratory, to NIST, or to another
internationally recognized standards agency.
• Certified photocopies of all type-approvals obtained for the product,
including CE marking and the like.
• Certified photocopies of the legal manufacturer’s ISO 9001 2000 quality
system certification.
• Where relevant, certified photocopies of the legal manufacturer’s ISO
14001 certification, EMAS registration or registration with an equivalent
environmental audit scheme. Conformity with an environmental audit
scheme is not mandatory; however preference will be given to
manufacturers who are able to demonstrate compliance with good
environmental practice.
• Where available, laboratory test report(s) proving conformity with the
product specifications.
• One sample of the product complete with data connection lead, external
sensor(s) (where offered) and software.
• Indicative cost of the product per unit, per 10 units and per 100 units EXW
(Incoterms 2000).
8. On-site maintenance:
Not applicable.
9. Change notification:
The legal manufacturer or reseller is required to advise WHO in writing of any
changes which adversely affect the performance of the product after PQS pre-
qualification has taken place.
WHO/PQS/E06/TR05.1 7 of 8 30 November 2006
10. Defect reporting:
The legal manufacturer or reseller is to required to advise WHO and the UN
purchasing agencies in writing in the event of safety-related product recalls,
component defects and other similar events.
Revision history:
Date Change summary Reason for change Approved
21 Sep 06 4.2.1: upper limit changed to Corrections. Response to final UK (30
+55°C. 4.2.2: lower limit changed review comments. EU RoHS November
to -20°C. 4.2.6: clause added. Directive material restrictions 2006 ' PQS
4.2.18: minor changes. 4.3.1: incorporated. secretariat)
temperature range changed. 4.6.3:
clarification. New clause 4.7.2.
4.7.3 and 4.7.4 deleted. 5. ‘CFC’
changed to ‘ozone-depleting’.
WHO/PQS/E06/TR05.1 8 of 8 30 November 2006
