Holtronic temperature and time indicators are designed and manufactured to meet the regulatory requirements that matter most to pharmaceutical, food safety and logistics organisations — HACCP,ISO, CE, RoHS and REACH.
Full compliance documentation, including calibration certificates, declarations of conformity and IATA battery reports, is available for every product in the neo® range.
Holtronic provides a complete set of compliance documentation for every product in the neo® range. Documents are available on request via the Holtronic support team and can be supplied at product level — linked to individual unit serial numbers — or as range-level declarations.
Evidence at every stage
Before a single neo® indicator is placed on a product, its compliance credentials are already in place.
This means that when a quality manager needs to qualify the neo® indicator as an approved instrument in their quality management system, or when a regulatory auditor asks for the supporting documentation, the entire compliance package is immediately available, not assembled after the fact.
Calibration certificate issued at manufacture — per serial number |
Declaration of Conformity available for all neo® products |
RoHS and REACH compliance declarations on file |
ATA battery compliance report available for air freight documentation |
In pharmaceutical, food safety and clinical environments, temperature measurement is not a relative judgement — it is a legal and scientific obligation. Regulators do not accept “approximately right”; they require documented evidence that the monitoring instrument used was calibrated against a traceable reference standard, that the calibration was performed at a defined date, and that the accuracy achieved meets the threshold required by the applicable standard.
Regulatory Frameworks
Pharmaceutical, food safety and logistics organisations operate under overlapping regulatory frameworks that each impose specific requirements on temperature monitoring equipment and documentation. The neo® range is designed from the ground up to address these requirements, not retrofitted to meet them.
Beyond operational regulatory frameworks, Holtronic neo® indicators are designed to meet the product safety, electromagnetic compatibility, hazardous substance and chemical registration requirements that apply to electronic measuring devices placed on the EU and UK markets. These standards apply to the device itself, independent of the cold chain application.
CE Marking neo® indicators carry CE marking confirming conformity with applicable EU directives; a Declaration of Conformity is available for each product
RoHS (2011/65/EU, as amended) neo® indicators comply with restrictions on hazardous substances in electronic equipment; compliance declaration available
REACH (EC No 1907/2006) substances of very high concern (SVHC) are assessed and comply with REACH registration and restriction requirements
ISO 17025 traceable calibration calibration is performed against standards traceable to national measurement institutes
EN 12830 / EN 13485 temperature recorder performance standards relevant to food and pharmaceutical applications are referenced in product design
neo® range complies with CE, RoHS, REACH and ISO traceability standards
HACCP is the internationally recognised framework for food safety management, mandated under EU Food Hygiene Regulations, US FDA standards and codex alimentarius guidelines worldwide. At its core, HACCP requires that Critical Control Points, including temperature, are continuously monitored, that deviations are immediately detected and that corrective action is documented.
Continuous temperature monitoring at Critical Control Points neo® indicators sample every 32 seconds throughout the monitored period
Immediate breach detection LED alarms activate at the moment a critical limit is exceeded for the defined duration
Irreversible deviation record HACCP requires that deviations are documented and cannot be concealed; Neo LED alerts are permanent
Product-level evidence HACCP documentation requires evidence that each product unit was maintained within safe temperature limits
Pre-configured food safety thresholds — 2–8°C, 2–25°C and custom chilled food configurations available
Neo range supports HACCP food safety monitoring requirements
Why IATA compliance matters for neo® indicators
Holtronic neo® indicators contain batteries and may be classified as Dangerous Goods under IATA DGR when shipped by air. The IATA battery compliance report identifies the applicable provisions and confirms that neo® indicators meet the requirements for safe air transport — essential for pharmaceutical distributors shipping indicators internationally.
What the IATA battery report confirms
Battery chemistry, capacity and dimensions · UN 38.3 testing compliance where required · Applicable IATA DGR provisions (Section II / Exemption) · Packaging and labelling requirements · Quantity per package limits for air shipment
Available for all neo® range products. Request the IATA battery compliance report via the Holtronic support team — essential for freight forwarder and customs documentation.
Yes. All Holtronic neo® indicators carry CE marking confirming conformity with applicable EU directives. A Declaration of Conformity is available for each product in the Neo range, identifying the applicable directives, harmonised standards and the authorised Holtronic signatory. The DoC is available on request via the Holtronic support team and is suitable for inclusion in QMS documentation, vendor qualification packages and regulatory submissions.
Yes. All Holtronic neo® indicators comply with the RoHS Directive (2011/65/EU, as amended by Delegated Directive 2015/863/EU) and the REACH Regulation (EC No 1907/2006). RoHS compliance confirms that no restricted hazardous substances are present above threshold concentrations in any neo® indicator. REACH compliance confirms that no Substances of Very High Concern (SVHCs) above threshold concentrations are present. Both declarations are available on request.
Yes. An IATA Dangerous Goods Regulations battery compliance report is available for all Holtronic neo® products. The report confirms battery chemistry, capacity, UN 38.3 testing compliance where applicable, and the applicable IATA DGR provisions under which neo® indicators may be shipped by air. This document is required by freight forwarders and customs authorities for international air shipment of neo® indicators and should be included in dangerous goods documentation packages. Request via the Holtronic support team.
Request the Holtronic neo® compliance documentation or contact our UK-based team to discuss your specific quality system requirements.
