A.1 Title and scope

Title:

Cold storage equipment for medical use

Scope:

Standardization in the fields of cold storage equipment for storing blood and blood products, reagents, medicines, vaccines, biological specimen, etc., in medical practice and medical research. The products within the scope include but not limited to:
- Medical use refrigerating and freezing storage cabinets temperature ranging from - 180 °C to +22 °C (less than);
- Medical use refrigerating and freezing storage warehouses;
- Medical use cold transporting equipment, including road, sea and air transportation;
- Medical use liquid nitrogen storage equipment;
- Other special medical use cold storage cabinets, such as blood platelet constant-temperature oscillation storage cabinets, blood plasma quick freezers, etc.
The work of PC 130 will include terminology, classification, reliability, performance requirements and testing methods, energy consumption measuring methods, commissioning, in-service maintenance and monitoring, inspection, temperature verification and calibration, management specification, digitalization management, environmental aspects, etc. Safety aspects are expected to be addressed as joint efforts between PC 130 and other related Committees.

Chair: Mr Jiang LI

Secretary: Ms Wenxiu HUANG

Assistant Secretary: Mr Jian Chen

Technical Officer: Mr Miroslav Siket

Standards Project Administrator: Ms Alexandra Robin

Participating countries (10): China, Switzerland, Finland, Germany, Greece, India, Japan, Korea, Russian Federation, United Kingdom;

Observer countries (14): Austria, Belarus, Belgium, Brazil, Czech Republic, Hungary, Ukraine, Iran, Poland, Sweden, Thailand, France, Saudi Arabia, Spain;

AG1: Strategy planning

WG2: Terminology and classification

WG3: Performance requirements and test methods for cold storage equipment for medical use

ahG4: Cold storage equipment for medical use - Part 2-X: Cryogenic liquid nitrogen storage equipment - Performance requirements and test methods

ahG5: Cold storage equipment for medical use - Part 2- X: Refrigerating and freezing cold store - Performance requirements and test methods

Reagents, medicines, vaccines, and biological products and specimens are widely used in bio-medical practice and research. In order to maintain the effectiveness and activity of various biological products, specific storage temperatures are required, which may range from -180°C to 22°C. For example, some of the inactivated vaccines, solutions and biological specimens need to be stored at temperature ranging between 2°C and 10°C. Frozen blood plasma needs to be stored at temperature below -20°C, while frozen red blood cells are required to be stored at -70°C. The Pfizer vaccines for Covid-19 need to be stored at temperature ranging between -80°C and -60°C. Hence, it is necessary to produce medical grade cold storage units with different technologies to meet different temperature requirements.

Based on the rapid development of sensors and the Internet of Things, the cold storage devices for medical use have been developed with different functions, including storage, failure monitoring, transportation and management of samples with different storage requirements. Currently, various types of cold storage devices have been widely used globally.

1. Cold storage equipment for drugs and reagents

For the cold storage of drugs and reagents, the development of biopharmaceutical technology has promoted the gradual expansion of the scale of global refrigerated drugs, according to the data released by Frost&Sullivan, the global biopharmaceutical market size reached US$297.9 billion in 2020, and is expected to reach US$530.1 billion in 2025. Almost all detection reagents involving antigens, antibodies and active enzymes need to be stored at low temperature, so the devices such as drug refrigerators and reagent refrigerators are widely used in the production and storage process of drugs and reagents in countries such as the United States, China, Germany, Japan, Singapore, South Korea, Poland, Denmark, etc.

2. Cold storage equipment for blood and its products

For the cold storage of blood and its products, storage device runs through the whole process of blood collection, component preparation, storage, distribution, transportation and clinical transfusion, so it is crucial to ensure the safety and effectiveness of various blood products. The global market size of blood products has been on the rise in recent years, and the global demand for blood products has further increased due to the COVID-19 epidemic. According to the data of Research and Markets, the global market size of blood products industry has reached US$40.1 billion in 2021 and is expected to increase to US$47.7 billion by 2027.The market size of blood products in China reached US$5.65 billion in 2021, with an average annual growth rate of 10.53%.

3. Cold storage equipment for biological samples

For the cold storage of biological samples, biobank is regarded as an important resource for basic research of life science, and plays an irreplaceable role in the research of human disease prediction, diagnosis and treatment, which is paid attention by many countries. UK Biobank is one of the largest human genetic cohort biobank in the world; The Danish Biobank stores more than 7.98 million human biological samples; The National Cancer Institute of the United States stores more than 800,000 tissue and organ samples from patients and healthy people, and more than 300 million human biological samples are stored throughout the United States; China has 63 major biobank, of which the China Bone Marrow Bank stores more than 3 million samples. According to the data of Mordor Intelligence, the global biobanking market size is expected to grow from $50.21 billion in 2023 to $64.06 billion in 2028, with a CAGR of 4.99% during the forecast period (2023-2028).

4. Cold storage equipment for vaccines

For the cold storage of vaccines, the life cycle of vaccines goes through production, transportation, storage and inoculation, and the vaccines may fail due to inappropriate temperature in any link, so it is crucial to ensure the quality of vaccines through cold storage. In 2021, the global vaccine market size (excluding COVID-19 vaccines) reached US $64 billion. In terms of the market size of various regions in the world, the market size of the United States, Europe and China was US $21.7 billion, US $18.5 billion and US $10.9 billion respectively, accounting for 33.91%, 28.91% and 17.03% of the global market. According to the prediction of China Insights Consultancy, the global vaccine market is expected to reach US $101 billion by 2030.

5. Cold equipment for medical cold chain logistics

Medical cold chain logistics is a temperature-controlled packaging, storage and transportation system for temperature-sensitive products, which uses refrigerated transport vehicles such as trucks, rail cars, water and air to ensure the quality of various vaccines, biological products and samples. The correct storage and transportation of medicines without loss of efficiency has become a major market demand in the medical field, and the seamless integrated operational ability of medical cold chain logistics in the transportation and delivery process has made medical cold chain logistics increasingly chosen around the world to store medical products, which has become one of the key factors driving the market. The increasing global demand for pharmaceuticals, vaccines and clinical trial materials in the current multi-disease epidemic world has also positively impacted the market. In addition, several national governments have implemented strict regulations to guarantee the efficient handling of temperature sensitive drugs on a global scale, which is also driving the market growth. Also, with development of sensors and digital technologies, real-time monitoring of vehicle running, temperature of the stored goods, as well as running track can be achieved.

Likely users of PC 130 standards are manufacturers, suppliers, testing and certification bodies, regulators, users (eg. medical institutions, pharmaceutical companies), cold chain logistics companies – all these stakeholders will be encouraged to be actively involved in developing PC130 standards.

The scope of PC 130 covers a wide range of products and parameters of interest for the related stakeholders:

Products： cold storage equipment for storing blood and blood products, reagents, medicines, vaccines, biological specimen, etc., in medical practice and medical research, including cold equipment in the cold chain logistic.

Parameters： reliability, performance requirements, testing methods, energy efficiency, in-service maintenance and monitoring, inspection, temperature verification and calibration, management specification, digitalization ,environmental aspects, etc.

With the progress of the research related to bio-medical and the medical and health industry, the global market of cold storage equipment for medical use has achieved great development, which stimulates the upgrading of the related products and technology. The trends in the related products technology, and application are characterized as follows:

1. Medical grade refrigerating and freezing units are widely used in bio-medical practice and research

As the biological products for clinical and medical use need extreme strict storage requirement, currently the medical grade refrigerating and freezing units are widely used in in hospitals, clinics, pharmaceutical companies, blood-banks, biobanks, biological institutes, laboratories, etc. in global to store the biological product. For example, refrigerators for conserved blood are used to store the blood from 2°C to 6°C; medical refrigerator with operating temperature 2°C to 10°C is used for the storage of some types of reagents, solutions, vaccines; some biological tissues, virus, vaccine are stored in the medical grade freezer with operating temperature from +20°C to -150°C, even to -180°C. Furthermore, in China, the medical refrigerating and freezing equipment are used in space stations and exploration ships for biological research.

2. Reliability about performance of the cold storage equipment for medical use is the key challenge.

With the consideration of the storage for biological and medical use, the stored objects, like the vaccine, blood plasma, virus, gene, etc., are normally with high-value, uniqueness and scarcity, and the damage to them is irremediable. In some cases, the storage period is quite long. Hence, the damage of the stored objects for treatment and testing due to improper storage may cause serious consequences, such as economic and scientific losses, even to public health. Hence, the reliability about performance, like the accuracy of temperature, stability temperature, the cooling speed, self-alarm for abnormal situation, in-service monitoring, is essential for the stored medicals.

3. The epidemic of Covid-19 has accelerated integration between the cold storage for medical use and the cold chain.

As vaccines and reagents in vitro testing of covid-19 become important and effective tools against the global epidemic. The need for storage and transportation of the vaccine, the reagent and the test sample has significant increase. For example, the vaccine and the reagent need to be delivered from warehouse to public hospital and clinic while the test samples need to be delivered from public testing point to laboratory and hospital. Hence, the cold storage equipment is integrated into the cold chain logistics, and the equipment for this scenario should be considered and standardized.

4. The digitization is one of main directions in future.

With the development of IoT (Internet of Things) technology, the digitization transform on the cold storage equipment for medical use will provide more secure and efficient storage management, which is an essential part of smart hospital and biobank.

Presently, there is no need for a systems approach as outlined in AC/33/2013

However, the following several liaisons can already be established within IEC and with ISO and other organizations:

IEC Internal TCs/SCs:

IEC/SC59M Performance of electrical household and similar cooling and freezing appliances

IEC/SC61C Safety of refrigeration appliances for household and commercial use

IEC/SC62D Particular medical equipment, software, and systems

IEC/TC66 Safety of measuring, control and laboratory equipment

TC 72 Automatic electrical controls

TC 104 Environmental conditions, classification and methods of test

External TCs/SCs:

ISO/TC 276 Biotechnology

ISO/TC 315 Cold chain logistics

The publications of PC 130 will be in line with clause 33 of Part 2 of the ISO/IEC Directives related to conformity assessment aspects. Most of the standards of PC 130 will include test specifications, reproducible test requirements, and test methods.

The standards produced by PC130 are intended to be used for certification purposes in the IECEE scheme, and the certificates issued are used to obtain or cover market approval requirements internationally.