prEN 18151
(Main)Refrigerators and freezers for laboratory and medical applications — Terminology, requirements, testing
Refrigerators and freezers for laboratory and medical applications — Terminology, requirements, testing
This document specifies terminology, requirements and test methods for electrically operated medical refrigerating appliances as defined in 3.2 intended for the cold storage of blood components, biological specimen, vaccines, medicines, reagents, or other laboratory preparations used in medical practice and research.
This document applies to medical refrigerating appliances equipped with a remote or integrated compression-type refrigerating system.
This document covers construction characteristics relevant for the thermal and energy performance.
This document does not cover hygienic and safety aspects and ergonomic principles.
NOTE Examples of standards for safety requirements applicable to medical refrigerating appliances are EN IEC 60335-1 and EN IEC 60335-2-89 or EN 61010-1 and EN IEC 61010-2-011.
This document is not applicable to:
- refrigerated incubators;
- refrigerated cells and refrigerated containers > 2 000 l;
- passive cooling equipment;
- appliances having functionality other than exclusively for storage;
- appliances intended for short term storage;
- appliances intended for fully or partially off-grid operation.
Kühl- und Gefrier-Lagerungsgeräte für Labor- und Medizinanwendungen - Terminologie, Anforderungen, Prüfung
Dieses Dokument legt die Terminologie, Anforderungen und Prüfverfahren für elektrisch betriebene medizi
nische Kühlgeräte nach der Definition in3.2 fest, die für die Kühllagerung von Blutbestandteilen, biologischen Proben, Impfstoffen, Medikamenten, Reagenzien oder anderen Laborpräparaten in der medizinischen Praxis und Forschung bestimmt sind.
Dieses Dokument gilt für medizinische Kühlgeräte, die mit einer externen oder integrierten Kompressionskälteanlage ausgestattet sind.
In diesem Dokument werden baulichen Merkmale behandelt, die für die thermische und energetische Leistung relevant sind.
In diesem Dokument werden keine Hygiene- und Sicherheitsaspekte und ergonomischen Grundsätze behandelt.
ANMERKUNG Beispiele für Normen zu Sicherheitsanforderungen, die für medizinische Kühlgeräte gelten, sind ENIEC60335-1 und ENIEC60335-2-89 oder EN61010-1 und ENIEC61010-2-011.
Dieses Dokument ist nicht anzuwenden für:
- Kühlbrutschränke;
- Kühlzellen bzw. Kühlcontainer >2000l;
- passive Kühlvorrichtungen;
- Vorrichtungen, die nicht ausschließlich zur Lagerung bestimmt sind;
- Vorrichtungen, die für die kurzfristige Lagerung bestimmt sind;
- Vorrichtungen, die für den vollständigen oder teilweisen stromnetzunabhängigen Betrieb bestimmt sind.
Réfrigérateurs et congélateurs pour les applications de laboratoire et médicales - Terminologie, exigences, essais
Le présent document spécifie la terminologie, les exigences et les méthodes d'essai pour les appareils de réfrigération médicaux électriques tels que définis en 3.2 destinés au stockage à froid de composants sanguins, d'échantillons biologiques, de vaccins, de médicaments, de réactifs ou d'autres préparations de laboratoire utilisé(e)s dans la pratique médicale et la recherche.
Le présent document s'applique aux appareils de réfrigération médicaux équipés d'un système de réfrigération à compression à distance ou intégré.
Le présent document couvre les caractéristiques de construction pertinentes pour la performance thermique et énergétique.
Le présent document ne couvre pas les aspects hygiéniques et de sécurité et les principes ergonomiques.
NOTE Des exemples de normes pour les exigences de sécurité applicables aux appareils de réfrigération médicaux sont l'EN IEC 60335 1 et l'EN IEC 60335 2 89 ou l'EN 61010 1 et l'EN IEC 61010 2 011.
Le présent document ne s'applique pas aux :
— incubateurs réfrigérés ;
— cellules réfrigérées et conteneurs réfrigérés > 2 000 l ;
— équipements de refroidissement passif ;
— appareils ayant une fonctionnalité autre qu'exclusivement pour le stockage ;
— appareils destinés au stockage à court terme ;
— appareils destinés à un fonctionnement entièrement ou partiellement hors réseau.
Hladilniki in zamrzovalniki za laboratorijske in medicinske namene - Terminologija, zahteve, preskušanje
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2025
Hladilniki in zamrzovalniki za laboratorijske in medicinske namene - Terminologija,
zahteve, preskušanje
Refrigerators and freezers for laboratory and medical applications - Terminology,
requirements, testing
Kühl- und Gefrier-Lagerungsgeräte für Labor- und Medizinanwendungen - Terminologie,
Anforderungen, Prüfung
Ta slovenski standard je istoveten z: prEN 18151
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.100.99 Drugi standardi v zvezi z Other standards related to
laboratorijsko medicino laboratory medicine
97.040.30 Hladilni aparati za dom Domestic refrigerating
appliances
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2024
ICS 01.040.11; 11.100.99; 97.040.30
English Version
Refrigerators and freezers for laboratory and medical
applications - Terminology, requirements, testing
Kühl- und Gefrier-Lagerungsgeräte für Labor- und
Medizinanwendungen - Terminologie, Anforderungen,
Prüfung
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 44.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 18151:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
3.1 General terms and definitions . 5
3.2 Types of medical refrigerating appliances . 6
3.3 Physical aspects and dimensions . 7
3.4 Terms and definitions relating to performance characteristics . 8
3.5 Terms and definitions related to test environment . 10
4 Symbols and abbreviations . 11
5 Classification and requirements . 11
5.1 Classification according to the storage temperature range . 11
5.2 Classification according to the climate class . 11
5.2.1 Climate classes for refrigerators and laboratory, plasma and ultralow freezers . 11
5.2.2 Climate class for cryogenic freezers . 12
5.3 Requirements . 12
5.3.1 Construction . 12
5.3.2 Installation requirements . 13
5.3.3 Materials . 14
5.3.4 Refrigerating system . 15
5.3.5 Electrical components . 15
5.3.6 Operating characteristics . 16
5.3.7 Markings . 18
6 Testing . 19
6.1 General. 19
6.1.1 General test conditions . 19
6.1.2 Dimensions. 21
6.1.3 Gross volume . 21
6.1.4 Net volume. 21
6.1.5 Loading capacity of the storage surfaces . 21
6.1.6 Latching system for appliance door/flap and lid . 21
6.1.7 Appliance door seal and/or lid seal . 21
6.1.8 Air temperature and product temperature. 22
6.1.9 Appliance insulation / condensation formation . 28
6.1.10 Relative duty cycle / needed capacity . 28
6.1.11 Standard energy consumption . 29
7 Test report . 29
Annex A (informative) Exemplary method for product temperature testing of loaded blood
bank refrigerators and loaded plasma storage appliances . 31
Annex B (informative) Schematic overview of important terms for temperature testing . 37
Annex C (normative) Net volume calculation . 38
Bibliography . 40
European foreword
This document (prEN 18151:2024) has been prepared by Technical Committee CEN/TC 44
“Commercial and Professional Refrigerating Appliances and Systems, Performance and Energy
Consumption”, the secretariat of which is held by UNI.
This document is currently submitted to the CEN Enquiry.
1 Scope
This document specifies terminology, requirements and test methods for electrically operated medical
refrigerating appliances as defined in 3.2 intended for the cold storage of blood components, biological
specimen, vaccines, medicines, reagents, or other laboratory preparations used in medical practice and
research.
This document applies to medical refrigerating appliances equipped with a remote or integrated
compression-type refrigerating system.
This document covers construction characteristics relevant for the thermal and energy performance.
This document does not cover hygienic and safety aspects and ergonomic principles.
NOTE Examples of standards for safety requirements applicable to medical refrigerating appliances are
EN IEC 60335-1 and EN IEC 60335-2-89 or EN 61010-1 and EN IEC 61010-2-011.
This document is not applicable to:
— refrigerated incubators;
— refrigerated cells and refrigerated containers > 2 000 l;
— passive cooling equipment;
— appliances having functionality other than exclusively for storage;
— appliances intended for short term storage;
— appliances intended for fully or partially off-grid operation.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN IEC 60335-1, Household and similar electrical appliances - Safety - Part 1: General requirements
EN IEC 60335-2-89, Household and similar electrical appliances - Safety - Part 2-89: Particular
requirements for commercial refrigerating appliances and ice-makers with an incorporated or remote
refrigerant unit or motor-compressor
EN 61010-1, Safety requirements for electrical equipment for measurement, control, and laboratory
use — Part 1: General requirements
EN IEC 61010-2-011, Safety requirements for electrical equipment for measurement, control, and
laboratory use - Part 2-011: Particular requirements for refrigerating equipment
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1 General terms and definitions
3.1.1
medical refrigerating appliance
insulated cabinet with one or more compartments that are controlled at specific temperatures and are
of suitable size and equipped for laboratory and medical use, cooled by natural convection or a forced
convection system whereby the cooling is achieved by one or more energy-consuming components
Note 1 to entry: Medical refrigerating appliance is hereafter referred to as refrigerating appliance.
Note 2 to entry: Medical refrigerating appliances are used for storage of products of human and non-human origin,
like blood components, human cells and tissues, pharmaceuticals, vaccines, chemicals, veterinary products and
products of animal origin.
3.1.2
refrigerant
fluid used for heat transfer in a refrigerating system, which absorbs heat at a low temperature and at a
low pressure of the fluid and rejects heat at a higher temperature and at a higher pressure of the fluid,
usually involving changes of phase of the fluid
3.1.3
condenser
heat exchanger from which heat in the refrigerant is rejected to an external cooling medium (usually
the air surrounding the appliance)
3.1.4
evaporator
heat exchanger which absorbs heat from the compartment to be refrigerated and transfers this to the
refrigerant
3.1.5
compression-type refrigerating system
system in which refrigeration is affected by the vaporization at low pressure in a heat exchanger
(evaporator) of a liquid refrigerant, the vapour thus formed being restored to the liquid state by
mechanical compression to a higher pressure and subsequent cooling in another heat exchanger
(condenser)
3.1.6
refrigerating system
compression-type refrigerating system of the refrigerating appliance
3.1.7
refrigerated product
refrigerated or frozen products that can be stored in refrigerating appliances
EXAMPLE Products are substances for laboratory use, medicinal products, vaccines, plasma or blood.
3.1.8
plasma
liquid part of unclotted blood
Note 1 to entry: Plasma samples can contain anti-coagulants.
3.1.9
blood product (blood and blood components)
whole blood, red cells, froze
...
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