Saturday, August 30, 2025

Hypoxic Chambers used in National Athletic Research Institutes - Your Questions Answered Here

 


Hypoxic Chamber Supplied by QRA to Sport Singapore in 2016 

Consumer-friendly and professional hypoxic chambers are now a normal part of endurance development and team sport conditioning. Recently, the fitness industry has become a customer of hypoxic chambers, as the rapid adaptations that altitude simulators provide is commercially appealing.

In this buyer’s guide, we review the details of investing in altitude chambers and cover the necessary terminology, science, and practical considerations so coaches and high performance staff will have the necessary information to get started. The benefits are simple: improved aerobic capacity from specific hematological adaptations that improve athlete stamina. Most of the research supports what we can do with altitude tents and indoor hypoxic chambers, but the magnitude is still unknown when addressing their real-world impact on athlete careers versus short studies. The final word on how to use the technology will be up to the sport scientists and coaches, but for now the use of altitude tents has merit.

What Is a Hypoxic Chamber?



Athletic Chamber in Aspire Hospital Doha Qatar
Proudly Supplied by QRA International in 2017 


A hypoxic chamber is an area of any size that simulates altitude conditions, and applications range from specialized training rooms to bed tents that allow athletes to sleep with the physiological conditions found at higher elevations. Don’t confuse hypoxic chambers with hyperbaric chambers, or systems that increase the oxygen content of the local environment. Hypoxic conditions are researched to help intensify the adaptation process, but the effects relate highly to the entire training program and lifestyle of the athlete. While the systems are mainly for enhancing athlete performance, some treatments are for non-athlete use, such as wellness centres and rehabilitation clinics.

Don’t confuse hypoxic chambers with hyperbaric chambers.CLICK TO TWEET

There are three categories of equipment currently available: small sleep space areas, direct breathing devices, and training room solutions. All three systems can help an array of athletes, ranging from elite endurance athletes to senior populations. The popularity of hypoxic chambers is growing in Europe, and they are now available in the U.S. for fitness and performance demands. Hypoxic chambers are not like gas analyzers or commercial restricted breathing masks, as oxygen utilization and restricted breathing are not true hypoxic technologies.

Single user breathing devices are systems that replicate altitude by directly connecting the individual athlete to an inhalation stimulus similar to elevation. The athlete can sleep or train with the system, and the surrounding area maintains normal conditions. Like a CPAP machine, but clearly designed to stress the athlete incrementally instead of restore breathing, the technology is safe and effective.

Sleeping areas are commercially available, and due to their size and the user experience, they are popular with recreational athletes and team sports. Because of the invasiveness to sleep, specifically the social barriers, the market isn’t close to saturation in the space. Hypoxic sleeping devices resemble tents, and are often referred to as altitude tents to convey the concept of the appearance and function of the solution. Some systems are reportedly uncomfortable to sleep in because the temperature can be slightly warmer than ideal conditions, so decreasing the bedroom’s temperature is the common adjustment.

Training zones require specialized construction of the room to ensure the space is literally airtight. Sizes range from small single training areas that athletes can cycle in individually all the way to team-sized environments. In addition to an airtight area with unique entryways, altitude generators are required to alter the internal environment and replicate elevation. Training areas with hypoxic technology are very popular with athletes in team sport. While most in team sports are not interested in sleeping high artificially, all athletes use the training chambers.

How Does a Hypoxic Chamber Work?

Inside the Sport SG Chamber 

Control 
Temperature : 0 to 50 C
Humidity : 20 - 95%
Altitude : 0 - 5000 m
CO2 Control : 400 ppm for 2 hours with 4 athletes

A hypoxic chamber is an artificial environment solution that senses the ambient conditions of the local area and has the ability to distort the oxygen profile, thus simulating altitude. The equipment makes calculations that increase or decrease the simulation with a high level of accuracy. In summary, a hypoxic chamber fools the body into believing the athlete is at elevation.

Similar to an air compressor, the generators are about the size of a washer and dryer, and sometimes larger than full-size refrigerators depending on the amount of air treated. Due to the electrical energy required to modify large spaces, the temperature of the generators used to be an issue in confined spaces. It’s important that coaches and others involved recognize that air flow is purposely restricted in hypoxic chambers, so air conditioning and air filtering is sometimes a challenge.

In summary, a hypoxic chamber fools the body into believing the athlete is at elevation.CLICK TO TWEET

Small systems use similar technology, but tents and other small-space solutions are not as powerful because they use fewer cubic litres than full room chambers for teams and large groups. Mask solutions are similar, meaning they utilize the same engineering but on a far smaller scale. Partial pressure of tents and other systems is not modified by technology, therefore the main difference with air at sea level is its nitrogen and oxygen ratio.

What Does the Science Say About Hypoxic Training ?

The physiology of simulated altitude is important because athletes who artificially live high but train at sea level improve their tolerance and adaptations, but do not fully prepare for the rigors of altitude. Conversely, those who train in hypoxic conditions with short intervals also limit their exposure to altitude, as it requires a combination of living and training to fully capture the absolute benefits of elevation to the body. Team training is also usually limited to cross-training or non-specific conditioning, so the transfer and replication of game conditions are not interchangeable. The amount of general training that transfers at sea level is conflicting, but added conditioning at altitude or simulated altitude does have a stronger influence on adaptations specific to aerobic performance.

Nearly all of the improvements in aerobic capacity will come from the mitochondrial, hematological, and cardiopulmonary adaptations. Concurrent training methods that incorporate both power and endurance should be enough to preserve an athlete’s ability to produce power, and extend the aerobic capacity to repeat it and conserve those capabilities. The rate of decay—meaning how quickly the adaptations occur—is highly dependent on a myriad of factors, mainly training, genetics, diet, and recovery.

Genetic factors are a real component in the success of athletes, as some athletes don’t seem equipped to harness the simulated altitude. Conversely, some athletes are high responders due to their genetic profile. Other circumstances make hypoxic training invaluable, such as immobile athletes after surgery or illness. Based on the research, it’s not clear who makes an ideal candidate for altitude training, so determining the athletes who are best fit to use altitude simulation with hypoxic rooms and tents is a difficult process.

Standard Features and User Experience



Sports SG Chamber can fit in :
a) 4 Olympic Sized Treadmills
b) 2 Cycling Machines

Most, if not all, of the systems available have a limited warranty (up to 24 months) for conventional use. Some chamber systems have maintenance packages or agreements that minimize expenses, and nearly all of them have been tested for safety and effectiveness. Many of the features are universal, meaning the market is not dramatically different, just similar enough that comparisons are not necessary outside of basic information on offerings and prices.

We don’t intend to oversimplify, but hypoxic chambers are very similar to air conditioning units, as they display simple environmental data and provide a solution to change the conditions accordingly. As for the private or individual products, each system has ergonomics and design differences that are small but reliable for purchasing, such as workflow and simplicity. Unlike equipment in our other buyer’s guides, individual key features are not the primary selling point.

What Options Exist with Hypoxic Technology (Rooms, Tents, Face Masks)?

There are a handful of players in the space and most of the companies support all of the markets, ranging from serious weekend warrior to professional institutions. We list the five companies that lead the industry for hypoxic chambers, tents, and individual systems. While the choice of options is narrow, each company’s experience should give you confidence that they’ll still be around in a few years, despite the fact that the sports technology market can be so volatile.

Worldwide Suppliers 

1. Hypoxico (USA)

2. Sporting Edge (UK)

3. QRA International (Singapore)

4. Higher Peak (UK).


QRA International Pte Ltd

www.qra.com.sg

Email :qrasales@qra.com.sg

           mark@qra.com.sh

Tel     : (65) 6795 1486

21 Toh Guan Road East

#04 - 02 Toh Guan Centre

Singapore 608609

Supplying world class Hypoxic Environmental Chambers to the World 

Friday, August 29, 2025

ASTM F 1980 all your questions answered here in this post

 


QRA INTERNATIONAL 
INCORPORATED 2003 (SINGAPORE)
PROVIDING BIOMEDICAL AGING TEST SERVICES FOR OVER 15 YEARS


1. What is a Medical Device ? 

Medical devices are an article, instrument, apparatus or machine that is used in the      prevention, diagnosis or treatment of illnesses or diseases. They can be used for detecting, measuring, restoring, correcting or modifying the structure of the body for some health benefit.

Examples of Medical Devices

a) Contact Lenses

b) Blood Pressure Monitors

c) Hearing Aids

d) Heart Pacemakers

e) Tooth implants

    2. What is ASTM F1980  ?


   Standard for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ASTM F1980 is a test standard titled, "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices" is a testing procedure that is used to help with the assessment of the sterile integrity of a package and product designed for medical use.

In order to validate a product and package's Sterile Barrier System (SBS) over the intended storage shelf life,

Accelerated Aging is conducted to evaluate a package and product's long term usability and efficacy. ASTM F1980 is a specific accelerated aging test protocol set forth by ASTM International (American Standards for Test and Measurement International)

Shelf Life Test is then conducted to benchmark the product. Essentally it is to keep the product at the ambient temperature and humidity conditions for the entire duration of the product's useful life. This may be 3 years, 5 years or even 8 years. 

If the manufacturer wishes to sell his products into the world's largest market for medical devices, the USA, it needs to have its final products tested and passed according to ASTM F1980 - 21. 

In Europe it is known as the ISO 11607 


3.ASTM F1980-21 replaced F1980-16 in December 2021. What changed?

The revisions' primary change recommends that the use of controlled humidity during accelerated aging be considered, findings documented and used during testing if warranted.

The need for controlled humidity should be based on the characterization data of the materials used in the medical device, it's packaging, and the long term storage condition.


4. What is the Purpose of ASTM F1980 ? 

To function safely and effectively, medical devices must maintain their sterile integrity throughout their shelf-life. However, over time, the physical properties of the materials may degrade in certain environments and, as a result, may negatively impact the safety and efficacy of the product. Because they endure so many unique environments while being transported, used and stored.


Medical devices must undergo shelf life testing in addition to sterile integrity testing. ASTM F1980 specifically evaluates the aging process along with its package and how it impacts sterility and shelf-life. 


Accelerated aging therefore simulates these conditions by exposing the materials to elevated temperatures for shorter periods of time to represent an equivalent real time shelf life duration,


F1980 testing offers valuable safety and performance insights to manufacturers. 

With greater understanding of the aging process on a product and its package system as the result of testing, manufacturers can make more informed decisions regarding the handling, storing, and use of the product. Additionally, precise aging tests achieved by tight temperature tolerances offer enhanced assurance among regulatory agencies and consumers.



 
QRA Lab 1 at 21 Toh Guan Road East,
04 - 02 Toh Guan Centre
Singapore 608586

5. What is the procedure for an accelerated aging test for medical devices?

In accelerated aging tests for medical devices, a material or Sterile Barrier System (SBS) is exposed to elevated temperatures for a condensed amount of time. By exposing the testing materials to more extreme conditions during a shorter time frame, researchers can evaluate how a product will age under normal conditions without waiting for the entire desired duration. Armed with this knowledge, manufacturers can determine shelf life, storage, in-use, and transportation parameters more accurately for their product.

Accelerated aging is a standard practice in the medical device industry for determining shelf life parameters by accelerating the effects of time on a Sterile Barrier System (SBS).


The accelerated aging process is based on the relationship between temperature and reaction rate, in which the reaction rate increases as the temperature rises. The Arrhenius Equation is the basic formula used for an accelerated aging test for medical devices is:

Accelerated Aging Time (AAT)= Desired Real Time (RT) divided by the Accelerated Aging

Factor (AAF)

ln summary

Every 10 C increase in ageing temperature shortens the AAT by half.

Therefore if you have a product whose expected shelf life is 3 years or 36 months, the device is expected to 'ageor experience :

>  for ambient storage 25 C ; keeping the product in a chamber at 35 C, the product is expected to 'age' in 18 months.

>   for ambient storage 25 C ; keeping the product in a chamber at 45 C, the product is expected to 'age' in 9 months.

>   for ambient storage 25 C ; keeping the product in a chamber at 55 C, the product is expected to 'agein 4.5 months.


Therefore for a product with a shelf life of 3 years ; storage at 25 C 

a) Storage at 35 C  ; RH at 50 % RH  Aging Test Duration : 18 months

b) Storage at 45 C ; RH at 50% RH   Aging Test Duration : 9 months

c) Storage at 55 C ; RH at 50 % RH  Aging Test Duration : 4.5  months


QRA INTERNATIONAL offers Accelerated Aging Tests and Shelf Life Tests at most competitive prices internationally. Its 2 Labs with 20 Test Chambers are there running daily 24 hours a day, 7 days a week for your peace of mind.

We provide the following for a flat inexpensive fee. 

a) Monthly aging tests using top quality chambers from Germany, S.Korea, China        and Singapore. Test Durations : 4.5 months up to 60 months. 

b) Regular Test Reports Monthly, at start of test and at end of test.

c) Calibration Reports according to ISO 17025 (SINGLAS) for each test chamber prior to test.

d) DHL collection and delivery anywhere in the world 24 / 7.




QRA Lab 2 at 7 Perahu Road
Singapore 718 836

6. What are some of the parameters for ASTM F1980 testing?

ASTM International sets forth specific test parameters to ensure consistent testing across different lab facilities. The basic parameters for ASTM F1980 include the following:

1.    Accelerated Aging Temperature (ASTM F 1980 -16)

2.    Humidity (F1980 - 21)

3.   Quantity of product testing samples (for 90% confidence and 90% reliability)

7.  What do I do after the Accelerated Aging and Shelf Life Tests ? 

After the Accelerated Aging Tests, it is advisable to send your medical products to

a)    Peel Test

b)    Bubble (full immersion) Test

to determine the Confidence and Reliability Levels. QRA can advise you on these matters.

7.Arrhenius Equation ; What is it ? Why is it Useful ?

Using the Arrhenius Equation, the TRT should accurately reflect the actual product storage and in-use conditions, generally between 20°C and 30°C.

Accelerated aging temperature should be identified prior to testing. This is done by having in-depth knowledge of your materials, product, and packaging. It is not recommended to exceed +65 °C.

The need for controlled humidity during accelerated aging should be identified prior to testing; if materials are subject to moisture degradation, 45% - 55% RH is suggested. This input should be determined with your material providers' assistance.

A Q10 factor needs to be determined, which involves testing materials at various temperatures and defining the differences in reaction rate for a 10° change in temperature. A typical Q10 factor used during testing is 2.

Accelerated aging factor should be specified using the following equation:

AAF = Q10 (TAA-TRT) /10

QRA's sales professionals can walk you through your product ageing test needs. 

What is the best temperature to use for an ASTM F1980 test?

The ASTM F1980 standard suggests using an accelerated aging temperature below 60°C. Aging your product at a greater temperature provides the advantage of a faster simulation of the aging interval, but this comes with risks for particular products and packaging materials. Medical devices are often engineered with delicate materials that may drastically change when exposed to temperatures exceeding +60°C. Finding out if your medical product or device may be adversely affected by long periods of high heat or low humidity is a good place to start when choosing the best accelerated aging temperature. Westpak's experts can help you define the ideal temperature parameters for your products and packaging.

Common Accelerated Aging Temperatures: 50 C, 55 C, 57 C or 60 C

8. What is the best humidity level to use for accelerated aging?

Humidity usage is dependent on the materials used in your product and packaging, how moisture impacts them, and other environmental factors. If humidity during accelerated aging is to be controlled, we recommend either 50% rH to 60% rH to be used.

The humidity aspect of the aging should also be documented.

QRA INTERNATIONAL can assist you in this with all our reports clearly stating the parameters controlled and any deviation of these set parameters.


9. How do you evaluate the ASTM F1980 test, post-aging?

After a testing sample has undergone the accelerated aging process, its physical properties and package integrity will be compared against various aging time points.

This includes as per ASTM F1886, 

1. Peel Testing

2. Bubble Test 

3. Dye Test

10. Can You Recommend the Test Protocols for my product to test under ASTM F 1980 and or ISO 11607 ? 


Yes We Can. Our recommendations will be based on your company's unique product, expected shelf life and how much you value your brand.We have decades of experience at our Labs to guide you along your way to brand excellence and reliability.  

Contact us by email at :

                      qrasales@qra.com.sg

                           mark@qra.com.sg

        Website :    www.qra.com.sg

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