EN 12830-2018 Temperature recorders for the transport storage and distribution of temperature sensitive goods - Tests performance suitability.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Temperature recorders for the transport, storage and distribution of temperature sensitive goods - Tests, performance, suitabilityBS EN 12830:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12830 August 2018 IC

2、S 17.200.20; 67.260 Supersedes EN 12830:1999English Version Temperature recorders for the transport, storage and distribution of temperature sensitive goods - Tests, performance, suitability Enregistreurs de temprature pour le transport, le stockage et la distribution des marchandises thermosensible

3、s - Essais, performance, aptitude lemploi Temperaturregistriergerte fr den Transport, die Lagerung und die Verteilung von temperaturempfindlichen Produkten - Prfungen, Leistung, Gebrauchstauglichkeit This European Standard was approved by CEN on 2 March 2018. CEN members are bound to comply with the

4、 CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management

5、 Centre or to any CEN member. This European Standard exists 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 a

6、s the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Ne

7、therlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2

8、018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12830:2018 ENational forewordThis British Standard is the UK implementation of EN 12830:2018. It supersedes BS EN 12830:1999, which is withdrawn.The UK participation in its prepar

9、ation was entrusted to Technical Committee RHE/19, Commercial refrigerated food cabinets (cold room and display cases).A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a cont

10、ract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 96496 1ICS 17.200.20; 67.260Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published unde

11、r the authority of the Standards Policy and Strategy Committee on 31 August 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 12830:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12830 August 2018 ICS 17.200.20; 67.260 Supersedes EN 12830:1999Englis

12、h Version Temperature recorders for the transport, storage and distribution of temperature sensitive goods - Tests, performance, suitability Enregistreurs de temprature pour le transport, le stockage et la distribution des marchandises thermosensibles - Essais, performance, aptitude lemploi Temperat

13、urregistriergerte fr den Transport, die Lagerung und die Verteilung von temperaturempfindlichen Produkten - Prfungen, Leistung, Gebrauchstauglichkeit This European Standard was approved by CEN on 2 March 2018. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate

14、the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standa

15、rd exists 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 natio

16、nal standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serb

17、ia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and

18、 by any means reserved worldwide for CEN national Members. Ref. No. EN 12830:2018 EBS EN 12830:2018EN 12830:2018 (E) 2 Contents Page European foreword . 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 7 4 Concepts 11 4.1 General . 11 4.2 Temperature recorder elements 12 4.3 Temperatur

19、e recorder architecture (or configuration) 12 4.3.1 General . 12 4.3.2 Monolithic instrument . 13 4.3.3 Monolithic instrument with external relevant data 13 4.3.4 Temperature recorder with digital probes 14 4.3.5 Temperature recorder on the cloud . 15 5 Requirements 16 5.1 General . 16 5.2 Measuring

20、 range . 17 5.3 Protection of the data from manipulation 17 5.3.1 General . 17 5.3.2 Audit trail 17 5.3.3 Clearly readable data copies 17 5.3.4 Safekeeping of accessibility of the data . 17 5.3.5 Safekeeping of readability of the data 18 5.3.6 Safekeeping of correctness of the data . 18 5.3.7 Access

21、 restrictions . 18 5.3.8 Detailed documentation of the software . 18 5.4 Locking of settings . 18 5.5 Recording 18 5.5.1 General . 18 5.5.2 Traceability 18 5.5.3 Chart only for mechanical recorder 19 5.6 Autonomous power supply . 19 5.7 Degree of protection provided by the enclosure 19 5.8 Electrica

22、l safety (if applicable) 19 5.9 Operating characteristics linked to external electrical influences 20 5.9.1 External supply voltage (if applicable) 20 5.9.2 Autonomous supply (if applicable) . 20 5.9.3 Frequency (AC) (if applicable) 20 5.9.4 Power cut-offs 20 5.9.5 Electrical power disturbances and

23、susceptibility to radiated electromagnetic field . 20 5.10 Metrological characteristics and usage profiles . 20 5.10.1 General . 20 5.10.2 Metrological characteristics . 20 5.10.3 Usage profiles 22 5.11 Data security 22 BS EN 12830:2018EN 12830:2018 (E) 3 5.12 Software verification levels 22 6 Test

24、methods 23 6.1 Test list . 23 6.2 General conditions for tests 24 6.2.1 Pre-tests adjustments . 24 6.2.2 Normal atmospheric conditions 24 6.2.3 Reference conditions . 24 6.3 Determination of temperature measurement error . 25 6.3.1 Test method 25 6.3.2 Reading the recording 25 6.3.3 Expression of re

25、sults . 25 6.4 Determination of response time . 26 6.5 Determination of time recording error 26 6.6 Action of influence quantities 27 6.6.1 General . 27 6.6.2 Variation in voltage supply (if applicable) 27 6.6.3 Influence of ambient temperature . 27 6.6.4 Temperature testing under storage and transp

26、ort conditions for the recorder 28 6.6.5 Shock resistance test (if applicable) 28 6.6.6 Mechanical vibrations (if applicable) 28 6.6.7 Degrees of protection provided by enclosures (IP Code) 29 6.6.8 Electrical safety (if applicable) 29 6.6.9 Dielectric strength (if applicable) 29 6.7 Software test .

27、 29 6.7.1 Test objective . 29 6.7.2 Test procedure 29 7 Conditions of acceptance . 33 7.1 Requirements . 33 7.2 Operating error limits . 33 8 Marking 34 9 Initial and periodic verification 34 Annex A (normative) Software testing . 35 A.1 Software test general part Test objective . 35 A.2 Test proced

28、ure 35 A.2.1 General . 35 A.2.2 Determine the temperature recorder subunits 35 A.2.3 Determine the relevant software of each unit or subunit 35 A.2.4 Define the applicable test blocks of each unit or subunit 35 A.2.5 Determine the type of each unit or subunit 36 A.3 Software test for type P1 and typ

29、e P2 . 37 A.3.1 General . 37 A.3.2 Block G: Basic requirements . 37 A.3.3 Block L: Specific software requirements for long-term storage 48 A.3.4 Block T: Transmission of measurement data via Communication Networks. 55 BS EN 12830:2018EN 12830:2018 (E) 4 A.3.5 Block S: Software separation . 61 A.3.6

30、Block D: Download of relevant software . 64 A.4 Software test for type P3 . 69 Annex B (informative) Manufacturer software test form . 70 B.1 Identification . 70 B.1.1 Manufacturer identification . 70 B.1.2 Test object . 70 B.1.3 Documents list . 70 B.1.4 Define the applicable test blocks of each un

31、it or subunit (L, T, S and D) . 71 B.1.5 Selection of the type of each unit or subunit 71 B.2 Test requirement for type P1 and P2 73 B.2.1 General . 73 B.2.2 Basic requirements . 73 B.2.3 Extension L: Specific software requirements for long term storage . 80 B.2.4 Extension T: Specific software requ

32、irements for data transmission 84 B.2.5 Extension S: Specific software requirements for software separation . 87 B.2.6 Extension D: Specific software requirements 89 B.3 Test requirement for type P3 93 Annex C (informative) Example of data form describing suitability for use of equipment of a specif

33、ic series (to be filled in by the manufacturer) 94 Annex D (informative) Expected operation time and storage capacity . 95 D.1 Storage capacity dependent on the measurement interval 95 D.2 Battery lifetime dependent on usage 95 Annex E (informative) Required access to recorded data or functions is g

34、iven in Table E.1 96 BS EN 12830:2018EN 12830:2018 (E) 5 European foreword This document (EN 12830:2018) has been prepared by Technical Committee CEN/TC 423 “Means of measuring and/or recording temperature in the cold chain”, the secretariat of which is held by DIN. This European Standard shall be g

35、iven the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2019 and conflicting national standards shall be withdrawn at the latest by February 2019. Attention is drawn to the possibility that some of the elements of this document

36、may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 12830:1999. The standard has been completely revised and updated to the state of the art as follows: Scope was enlarged, i.e. location of sensors of the r

37、ecorder with respect to types of usage are included now; Update of Clause 2 “Normative references“; Update of Clause 3 “Terms and definitions“; Clause 4 “Concepts“ was added; Clause 5 “Requirements“ was enlarged, i.e. subclause 5.3 “Protection of the data from manipulation“ and 5.12 “Software verifi

38、cation levels“ were added and furthermore Clause 5 has been updated, e.g. values for maximum relative timing error and response time ; New subclause 6.7 “Software test“ and the related Annex A “Software testing“ and Annex B “Manufacturer software test form“ were added; New Annex D “Expected operatio

39、n time and storage capacity“ and Annex E “Required access to recorded data or functions“ were added. This European Standard is a document meeting the objectives of Directives: 92/1/EEC of January 13, 1992 of the Commission on the monitoring of temperatures in the means of transport, warehousing and

40、storage of quick-frozen foodstuffs intended for human consumption; 93/43/EEC of June 14, 1993 of the Council of the hygiene of foodstuffs and in particular on “temperature control criteria”. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following coun

41、tries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Po

42、land, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 12830:2018EN 12830:2018 (E) 6 1 Scope This document specifies the technical and functional characteristics of temperature recorders for the transport, storage and distribution of tem

43、perature sensitive goods between 80 C and +85 C. It specifies the test methods which allow the determination of the equipments conformity, suitability and performance requirements. It applies to the whole temperature recording system. The temperature sensor(s) may be integrated into the recorder or

44、be remote from it external sensor(s). It gives some requirements with regards to the location of sensors of the recorder with respect to types of usage such as transport, storage and distribution. NOTE Examples for the transport, storage and distribution of temperature sensitive goods between 80 C a

45、nd +85 C are chilled, frozen and deep frozen, quick frozen food, ice cream, fresh and hot food, pharmaceuticals, blood, organs, chemicals, biologicals, electronic and mechanical devices, flowers, plants, bulbs, raw materials and liquids, animals, art and furnishing. 2 Normative references The follow

46、ing 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 1348

47、6, Temperature recorders and thermometers for the transport, storage and distribution of chilled, frozen, deep-frozen/quick-frozen food and ice cream - Periodic verification EN 60529, Degrees of protection provided by enclosures (IP Code) (IEC 60529) EN 61000-6-2, Electromagnetic compatibility (EMC)

48、 - Part 6-2: Generic standards - Immunity for industrial environments (IEC 61000-6-2) EN 61000-6-3, Electromagnetic compatibility (EMC) - Part 6-3: Generic standards - Emission standard for residential, commercial and light-industrial environments (IEC 61000-6-3) EN 61010-1, Safety requirements for

49、electrical equipment for measurement, control and laboratory use - Part 1: General requirements (IEC 61010-1) ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories ISO/IEC 27001, Information technology - Security techniques - Information security management systems - Requirements BS EN 12830:2018EN 12830:2018 (E) 7 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at th