ISO 31513:2026

• Abstract:

  This document specifies temperature validation procedures and methods for temperature-controlled storage and land transport. This document applies to all types of temperature controlled goods except food. This document is not intended to evaluate the safety and technology of storage and land transport equipment or facilities. Warehouses and storages within production facilities are excluded from the scope of this document.

• Status: Published
• Publication Date: 05-Aug-2026
• ICS: 55.020 - Packaging and distribution of goods in general
• Technical Committee: ISO/TC 315 - Cold chain logistics
• Drafting Committee: ISO/TC 315 - Cold chain logistics
• Current Stage: 6060 - International Standard published
• Start Date: 06-Aug-2026
• Due Date: 26-May-2026
• Completion Date: 06-Aug-2026

Overview

ISO 31513: Temperature validation methods of temperature-controlled storage and land transport is an international standard developed by ISO/TC 315 (Cold Chain Logistics) that specifies comprehensive validation procedures and methods for temperature-controlled storage facilities and land-based transportation. It focuses on ensuring the integrity and quality of temperature-sensitive goods during distribution by providing a structured approach to temperature validation outside of manufacturing environments. This standard is applicable to all types of temperature-controlled goods except food, and is intended for logistics service providers, warehouse companies, and other stakeholders responsible for handling and transporting these products.

Key Topics

• Temperature Validation Procedure: Defines the general sequence of steps required to confirm that temperature-controlled environments and products are consistently maintained within specified temperature ranges.
• User Requirements Specification (URS): Outlines the legal, operational, technical, and product-specific parameters required for temperature management during storage and transport.
• Validation Plans: Provides guidance on drafting detailed validation strategies, establishing acceptance criteria, and assigning roles and responsibilities.
• Equipment and Systems Checking: Emphasizes the importance of equipment calibration, system maintenance, and pre-validation functionality checks to ensure reliable temperature control.
• Temperature Mapping: Describes methods for setting up data loggers, determining their placement, and using real or simulated products to identify temperature distribution and potential risk areas within storage or transport environments.
• Additional Tests: Includes procedures for temperature recovery (door opening), thermal conductivity (power failure), and, when necessary, humidity mapping to address environmental factors that may affect product quality.
• Data Analysis and Re-qualification: Provides recommendations for secure data management, regular re-qualification intervals, and criteria for ongoing monitoring and change control processes.

Applications

ISO 31513 is vital for organizations that store or transport pharmaceuticals, chemicals, electronics, cosmetics, and other non-food products sensitive to temperature fluctuations. Key application scenarios include:

• Cold Chain Logistics Providers: Ensures regulatory compliance and consistent product integrity during storage and distribution by validating storage areas and delivery routes using standardized procedures.
• Warehouse Operators: Applies temperature mapping and validation plans to mitigate risks associated with temperature deviations, supporting quality control and audit readiness.
• Transport Companies: Implements robust temperature validation protocols for refrigerated trucks or vehicles, incorporating contingency plans for equipment failure, power loss, or emergency scenarios.
• Quality Assurance Teams: Uses the outlined validation methods and documentation practices to maintain traceability, support regulatory submissions, and prepare for inspections or audits.
• Regulatory Compliance: Facilitates adherence to national and international regulations and guidelines (e.g., WHO GDP) on the distribution of temperature-sensitive products outside of production facilities.

Related Standards

ISO 31513 complements and references several other key standards in cold chain logistics and temperature-controlled distribution:

• ISO 31510: Cold chain logistics-Vocabulary, providing standardized terminology for the sector.
• EN 12830: Temperature recording devices for the transport, storage, and distribution of temperature-sensitive goods-Testing, performance, and suitability.
• EN 13486: Temperature recorders and thermometers for measuring the ambient or internal temperature for the transport, storage and distribution-Periodic verification.
• ISO 23416: Guidelines for temperature-sensitive medicinal packages and their distribution.
• ISO 15378 and ISO 9000: Address user requirement specifications and qualification processes.
• ISO 11139 and ISO 22716: Provide foundational definitions for qualification, calibration, and documentation.

By adhering to ISO 31513, organizations can strengthen their cold chain management systems, reduce product loss due to temperature excursions, and ensure the quality and safety of temperature-sensitive goods throughout the distribution lifecycle. This standard supports integrated supply chain management and aligns with global best practices for temperature validation in storage and road transport sectors.

International
Standard
ISO 31513
First edition
Temperature validation methods of
2026-08
temperature-controlled storage and
land transport
Reference number
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Temperature validation procedure . 3
5 Temperature validation method . 4
5.1 Defining user requirement specifications (URS) .4
5.1.1 General .4
5.1.2 Temperature control .5
5.1.3 Data management and integrity .5
5.1.4 Equipment and system requirements .5
5.1.5 Operational and process requirements .5
5.2 Setting of validation plan .6
5.3 Checking of equipment and systems .6
5.4 Performing of temperature mapping .7
5.4.1 Data logger setup .7
5.4.2 Data logger placement .7
5.4.3 Loading quantity and pattern .7
5.4.4 Temperature data collection . . .8
5.5 Additional tests .8
5.5.1 General .8
5.5.2 Temperature recovery test (door opening test) .9
5.5.3 Thermal conductivity test (power failure test) .9
5.5.4 Humidity mapping .9
5.6 Data analysis .10
6 Re-qualification . 10
7 Change control .10
8 Reporting . 10
Annex A (Informative) Examples of temperature validation report .11
Bibliography .13

iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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This document was prepared by Technical Committee ISO/TC 315, Cold chain logistics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
Introduction
Proper cold chain management is a critical element in storing and distributing temperature-sensitive goods
in a temperature-controlled environment. As supply chains expand and become more complex, this area
becomes more important.
For example, during the global rollout of COVID-19 vaccines, certain vaccines required ultra-low
temperature storage of approximately -70 °C, which increased complexity to the existing pharmaceutical
cold chain system. Different vaccines had different transport and storage requirements, requiring multiple
temperature supply chains within the same logistics network. In particular, vaccines were distributed
globally, including in remote and rural areas with limited infrastructure.
Collaboration between governments, pharmaceutical companies, logistics providers, and health systems
was required, as well as coordination and validation of the proper maintenance of cold chains in each
country. However, the challenge was to validate that land transport and warehouses operating in different
countries and regions was able to maintain the required temperature continuity for the vaccine.
Quality must be maintained as planned by properly managing all processes, from manufacturing to
distribution. In order to validate the integrity of cold chain, it is expected that it is possible to perform risk-
based analyses and inspections at the highest scientific level possible, and to be documented within a quality
system.
Temperature validation of storage and land transport must be possible in order to enable the integrated
supply chain management of cold chain logistics. It aims to help ensure the quality and integrity of
temperature-sensitive goods in cold chain management.
If the temperature is not properly controlled or guaranteed, the quality of temperature-sensitive goods will
be affected, so the safety, stability and efficiency of users cannot be guaranteed. This document applies to the
temperature validation of storage and land transport for quality control during distribution of temperature-
sensitive goods.
This document is intended to help logistics service providers, such as trucking companies and warehouse
companies and all parties handling temperature-sensitive goods, to ensure the integrity of the goods
through a temperature validation process throughout the distribution process.
This document does not apply to warehouses and storage within production facilities, as these are typically
governed by existing good manufacturing practices (GMP) standards and integrated quality control systems
within manufacturing environments. The focus of this document on temperature validation methods in
external storage and land transport to ensure integrity during distribution.

v
International Standard ISO 31513:2026(en)
Temperature validation methods of temperature-controlled
storage and land transport
1 Scope
This document specifies temperature validation procedures and methods for temperature-controlled
storage and land transport. This document applies to all types of temperature controlled goods except food.
This document is not intended to evaluate the safety and technology of storage and land transport
equipment or facilities. Warehouses and storages within production facilities are excluded from the scope of
this document.
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.
ISO 31510, Cold chain logistics — Vocabulary
EN 12830, Temperature recording devices for the transport, storage and distribution of temperature-sensitive
goods - Testing, performance and suitability
EN 13486, Temperature recorders and thermometers for measuring the ambient or internal temperature for the
transport, storage and distribution of temperature sensitive goods - Periodic verification
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 31510 and the following apply.
ISO and IEC maintain terminological 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
temperature-sensitive goods
products whose quality can be adversely affected by temperature extremes
Note 1 to entry: The acceptable temperature range varies by product type. For example:
— pharmaceutical and biological products: typically 2 °C to 8 °C (per WHO Good Distribution Practices and ISO 23416);
— certain chemicals and industrial materials: specific ranges as per manufacturer guidelines;
— other regulated products (e.g., cosmetics, electronics) can follow industry-specific storage and handling
requirements.
Note 2 to entry: Qualified personnel and/or organizations shall perform validation process design and qualification
temperature requirements for specific products and should follow applicable standards such as ISO 23416
(temperature-sensitive medicinal packages), WHO GDP guidelines, and relevant national regulations.
[SOURCE: ISO 23416, 3.3, modified — The word “medicinal” is deleted from the term and the definition, and
Notes to entry have been added.]

3.2
temperature-controlled
sequence of transportation events, from the manufacturer to the end-user, which maintains temperature-
sensitive products within approved temperature specifications
Note 1 to entry: Maintaining temperature control during these transportation events ensures that product quality is
maintained.
[SOURCE: ISO 23416:2023, 3.4]
3.3
temperature validation
process of confirming that temperature-sensitive environments and products are maintained within the
required temperature range through monitoring and documentation
3.4
qualification
process to demonstrate the ability to fulfil specified requirements
Note 1 to entry: The term "qualified" is used to designate the corresponding status.
3.5
validation plan
plan for efficient and accurate validation
3.6
user requirement specification
URS
approved document that states the product specifications of the material produced on this equipment as
well as functional, operational and technical aspects of the equipment or process required to produce the
desired product
[SOURCE: ISO 15378:2017, 3.7.11]
3.7
temperature mapping
process of determining the temperature profile of a particular temperature-controlled environment or
process such as a heating and refrigerated devices, chambers and land transport by measuring multiple
points in a defined area over a specified study duration
3.8
re-qualification
repetition of part or all of validation for the purpose of confirming the continued acceptability of a specified
process
[SOURCE: ISO 11139:2018, 3.220.5]
3.9
worst case
most extreme condition or set of conditions at which a product or process can fail to conform when compared
to ideal conditions, including upper and lower limits and process conditions within standard operating
procedures
3.10
change control
activities for control of the output after formal approval of its product configuration information
[SOURCE: ISO 9000:2015, 3.3.10]

3.11
calibration
set of operations that establish, under specified conditions, the relationship between values indicated
by a measuring instrument or measuring system, or values represented by a material measure, and the
corresponding known values of a reference standard
[SOURCE: ISO 22716:2007, 2.6]
3.12
documentation
process of recording information and any relevant records (including electronic documents) related to the
land transport and distribution of temperature-sensitive goods
4 Temperature validation procedure
Temperature-controlled storage and land transport shall be suitable for use and prevent goods from
being exposed to conditions that can affect the stability of goods. It shall be guaranteed to maintain the
temperature conditions required during storing and transportation within the temperature range specified
by the user requirements specification.
Temperature validation procedure shall be planned while considering the facilities, equipment, utilities,
processes, and product’s life cycle. Either qualified personnel or organizations, or both, shall perform
validation process design and qualification. Validation objectives and process shall be clearly defined and
documented prior to the validation plan.
Figure 1 shows the general sequence of the temperature validation procedure.

Figure 1 — General sequence of the temperature validation procedure
5 Temperature validation method
5.1 Defining user requirement specifications (URS)
5.1.1 General
This step involves defining the service users, the objectives and scope of the temperature validation study,
legal requirements, information about the product being handled, and the defined tolerance levels, selecting
appropriate equipment and test methods, and developing a detailed validation protocol.
This includes systems and processes used for:
a) Continuous temperature monitoring and data logging.
b) Temperature mapping of land transport routes and storage areas.

c) Alarm management and emergency operations in the event of temperature fluctuations.
Sub-clauses 5.1.2 to 5.1.5 are user requirements that should be specified in the URS. This information should
be provided based on legal requirements or user requests.
5.1.2 Temperature control
a) Temperature range: The system should maintain the temperature-sensitive goods within a defined
temperature range (e.g., 2 °C to 8 °C, 15 °C to 25 °C) as specified by the product requirements.
b) Temperature monitoring: The system should provide continuous monitoring with data logs at specified
intervals. Data should be collected during both transport and storage.
c) Temperature mapping: Temperature mapping should be performed for all transport routes and storage
areas. Mapping should account for seasonal and environmental changes to verify worst-case scenarios.
5.1.3 Data management and integrity
a) Data integrity and security: Temperature data should be securely recorded and stored, preferably using
encryption or tamper-proofing technology.
b) Data retrieval and reporting: The system should provide customizable report formats to enable external
reporting.
c) Audit trail: All data access, changes, and system events should be tracked and maintained to support
existing regulatory compliance and traceability requirements.
5.1.4 Equipment and system requirements
a) Calibration and maintenance: All temperature monitoring equipment should be calibrated regularly and
traceable to national or international standards. There should be a documented maintenance schedule.
b) Alarm and warning system: The system should trigger an alarm (audible and visual) immediately when
the temperature deviates from the predefined threshold. The alarm can be sent to designated personnel
via SMS, email, or other communication channels.
c) Backup and redundancy: Backup systems (e.g., auxiliary power supply, redundant temperature sensors)
should be available to ensure continuous monitoring and control during equipment failure or power
outage.
d) Compatibility and integration: The monitoring and data management system
...