BS EN 12830:2018 – TC:2020 Edition
$280.87
Tracked Changes. Temperature recorders for the transport, storage and distribution of temperature sensitive goods. Tests, performance, suitability
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 205 |
This European Standard specifies the technical and functional characteristics of temperature recorders for the transport, storage and distribution of temperature sensitive goods between -80 °C and +85 °C. It specifies the test methods which allow the determination of the equipment’s conformity, suitability and performance requirements. It applies to the whole temperature recording system. The temperature sensor(s) may be integrated into the recorder or 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 and +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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 107 | undefined |
| 113 | 1 Scope 2 Normative references |
| 114 | 3 Terms and definitions |
| 118 | 4 Concepts 4.1 General |
| 119 | 4.2 Temperature recorder elements 4.3 Temperature recorder architecture (or configuration) 4.3.1 General |
| 120 | 4.3.2 Monolithic instrument 4.3.3 Monolithic instrument with external relevant data |
| 121 | 4.3.4 Temperature recorder with digital probes |
| 122 | 4.3.5 Temperature recorder on the cloud |
| 123 | 5 Requirements 5.1 General |
| 124 | 5.2 Measuring range 5.3 Protection of the data from manipulation 5.3.1 General 5.3.2 Audit trail 5.3.3 Clearly readable data copies 5.3.4 Safekeeping of accessibility of the data |
| 125 | 5.3.5 Safekeeping of readability of the data 5.3.6 Safekeeping of correctness of the data 5.3.7 Access restrictions 5.3.8 Detailed documentation of the software 5.4 Locking of settings 5.5 Recording 5.5.1 General 5.5.2 Traceability |
| 126 | 5.5.3 Chart only for mechanical recorder 5.6 Autonomous power supply 5.7 Degree of protection provided by the enclosure 5.8 Electrical safety (if applicable) |
| 127 | 5.9 Operating characteristics linked to external electrical influences 5.9.1 External supply voltage (if applicable) 5.9.2 Autonomous supply (if applicable) 5.9.3 Frequency (AC) (if applicable) 5.9.4 Power cut-offs 5.9.5 Electrical power disturbances and susceptibility to radiated electromagnetic field 5.10 Metrological characteristics and usage profiles 5.10.1 General 5.10.2 Metrological characteristics 5.10.2.1 Maximum permissible errors and resolution |
| 128 | 5.10.2.2 Operational requirements 5.10.2.3 Recording interval and storage capacity 5.10.2.4 Maximum relative timing error 5.10.2.5 Response time |
| 129 | 5.10.3 Usage profiles 5.10.3.1 Climatic environment 5.10.3.2 Mechanical vibrations 5.10.3.3 Shock resistance 5.10.3.4 Different versions and combinations of components 5.11 Data security 5.12 Software verification levels |
| 130 | 6 Test methods 6.1 Test list |
| 131 | 6.2 General conditions for tests 6.2.1 Pre-tests adjustments 6.2.2 Normal atmospheric conditions 6.2.3 Reference conditions |
| 132 | 6.3 Determination of temperature measurement error 6.3.1 Test method 6.3.2 Reading the recording 6.3.3 Expression of results |
| 133 | 6.4 Determination of response time 6.5 Determination of time recording error |
| 134 | 6.6 Action of influence quantities 6.6.1 General 6.6.2 Variation in voltage supply (if applicable) 6.6.3 Influence of ambient temperature 6.6.3.1 General 6.6.3.2 Test applicable to recorders with external sensor 6.6.3.3 Test applicable to recorders with internal sensor |
| 135 | 6.6.4 Temperature testing under storage and transport conditions for the recorder 6.6.5 Shock resistance test (if applicable) 6.6.6 Mechanical vibrations (if applicable) |
| 136 | 6.6.7 Degrees of protection provided by enclosures (IP Code) 6.6.8 Electrical safety (if applicable) 6.6.9 Dielectric strength (if applicable) 6.7 Software test 6.7.1 Test objective 6.7.2 Test procedure 6.7.2.1 Test organization |
| 137 | 6.7.2.2 Determine test objects and applicable test blocks 6.7.2.3 Determine the temperature recorder and its subunits 6.7.2.4 Determine the relevant software 6.7.2.5 Determine the applicable test blocks 6.7.2.6 Test block G: General |
| 138 | 6.7.2.7 Test block T: Transmission of measurement data via Communication Networks |
| 139 | 6.7.2.8 Test block S: Software Separation 6.7.2.9 Test block D: Download of relevant software |
| 140 | 6.7.2.10 Solution as a Service (SaaS) 7 Conditions of acceptance 7.1 Requirements 7.2 Operating error limits |
| 141 | 8 Marking 9 Initial and periodic verification |
| 142 | Annex A (normative)Software testing A.1 Software test general part – Test objective A.2 Test procedure A.2.1 General A.2.2 Determine the temperature recorder subunits A.2.3 Determine the relevant software of each unit or subunit A.2.4 Define the applicable test blocks of each unit or subunit |
| 143 | A.2.5 Determine the type of each unit or subunit |
| 144 | A.3 Software test for type P1 and type P2 A.3.1 General A.3.2 Block G: Basic requirements A.3.2.1 General A.3.2.2 Documentation |
| 145 | A.3.2.3 Software identification |
| 146 | A.3.2.4 Influence via user interfaces |
| 147 | A.3.2.5 Influence via communication interface |
| 149 | A.3.2.6 Protection against accidental or unintentional changes |
| 150 | A.3.2.7 Protection against intentional changes |
| 152 | A.3.2.8 Parameter protection |
| 153 | A.3.2.9 Software authenticity and presentation of results (only for type P2) |
| 155 | A.3.3 Block L: Specific software requirements for long-term storage A.3.3.1 General A.3.3.2 Completeness of measurement data stored A.3.3.3 Protection against accidental or unintentional changes |
| 157 | A.3.3.4 Integrity of data |
| 158 | A.3.3.5 Authenticity of measurement data stored |
| 159 | A.3.3.6 Confidentiality of keys A.3.3.7 Retrieval of stored data |
| 160 | A.3.3.8 Automatic storing |
| 161 | A.3.3.9 Storage capacity and continuity |
| 162 | A.3.4 Block T: Transmission of measurement data via Communication Networks A.3.4.1 General A.3.4.2 Completeness of transmitted data |
| 163 | A.3.4.3 Protection against accidental or unintentional changes |
| 164 | A.3.4.4 Integrity of data |
| 165 | A.3.4.5 Authenticity of transmitted data |
| 166 | A.3.4.6 Confidentiality of keys A.3.4.7 Handling of corrupted data |
| 167 | A.3.4.8 Transmission delay A.3.4.9 Availability of transmission services |
| 168 | A.3.5 Block S: Software separation A.3.5.1 General A.3.5.2 Realization of software separation |
| 169 | A.3.5.3 Mixed indication |
| 170 | A.3.5.4 Protective software interface |
| 171 | A.3.6 Block D: Download of relevant software A.3.6.1 General A.3.6.2 Download mechanism |
| 173 | A.3.6.3 Authentication of downloaded software |
| 174 | A.3.6.4 Integrity of downloaded software |
| 175 | A.3.6.5 Traceability of relevant software download |
| 176 | A.4 Software test for type P3 |
| 177 | Annex B (informative)Manufacturer software test form B.1 Identification B.1.1 Manufacturer identification B.1.2 Test object B.1.3 Documents list |
| 178 | B.1.4 Define the applicable test blocks of each unit or subunit (L, T, S and D) B.1.5 Selection of the type of each unit or subunit |
| 180 | B.2 Test requirement for type P1 and P2 B.2.1 General B.2.2 Basic requirements B.2.2.1 General B.2.2.2 Documentation B.2.2.3 Software identification |
| 181 | B.2.2.4 Influence via user interface |
| 182 | B.2.2.5 Influence via communication interface |
| 183 | B.2.2.6 Protection against accidental or unintentional changes |
| 184 | B.2.2.7 Protection against intentional changes |
| 185 | B.2.2.8 Parameter protection |
| 186 | B.2.2.9 Software authenticity and presentation of results (only for type P2) |
| 187 | B.2.3 Extension L: Specific software requirements for long term storage B.2.3.1 Completeness of measurement data stored B.2.3.2 Protection against accidental or unintentional changes B.2.3.3 Integrity of data |
| 188 | B.2.3.4 Authenticity of measurement data stored B.2.3.5 Confidentiality of keys |
| 189 | B.2.3.6 Retrieval of stored data |
| 190 | B.2.3.7 Automatic storing B.2.3.8 Storage capacity and continuity |
| 191 | B.2.4 Extension T: Specific software requirements for data transmission B.2.4.1 Completeness of transmitted data B.2.4.2 Protection against accidental or unintentional changes B.2.4.3 Integrity of data |
| 192 | B.2.4.4 Authenticity of transmitted data B.2.4.5 Confidentiality of keys |
| 193 | B.2.4.6 Handling of corrupted data B.2.4.7 Transmission delay B.2.4.8 Availability of transmission services |
| 194 | B.2.5 Extension S: Specific software requirements for software separation B.2.5.1 Realization of software separation |
| 195 | B.2.5.2 Mixed indication B.2.5.3 Protective software interface |
| 196 | B.2.6 Extension D: Specific software requirements B.2.6.1 Download mechanism |
| 198 | B.2.6.2 Authentication of downloaded software B.2.6.3 Integrity of downloaded software |
| 199 | B.2.6.4 Traceability of relevant software download B.2.6.5 Download consent |
| 200 | B.3 Test requirement for type P3 |
| 201 | Annex C (informative)Example of data form describing suitability for use of equipment of a specific series (to be filled in by the manufacturer) |
| 202 | Annex D (informative)Expected operation time and storage capacity D.1 Storage capacity dependent on the measurement interval D.2 Battery lifetime dependent on usage |
| 203 | Annex E (informative)Required access to recorded data or functions is given in Table E.1 |
