ISO 10993-10 sensitization test of skin-friendly foam foam delay agent 1027 in wearable devices

admin 3月 19th, 2025 News

ISO 10993-10 sensitivity test for skin-friendly foam foam delaying agent 1027 in wearable devices

1. Introduction: The Encounter of Foam and Sensitive Skin

In today’s era of rapid development of technology, wearable devices have become an indispensable part of people’s daily lives. Whether it’s smartwatches, health trackers or virtual reality glasses, these small and smart devices are being integrated into our lives in all forms. However, as these devices increase their contact time with the human body, the safety and comfort of materials have gradually become the focus of consumers’ attention. Especially when the device is in direct contact with the skin, any ingredient that can trigger an allergic reaction can be deterred.

Today, we will talk about a special “behind the scenes” – skin-friendly foam foam delaying agent 1027. This product may seem inconspicuous, but it is the key to making soft, light and skin-friendly foam. As a core material used in wearable devices, its performance not only determines the comfort of the product, but also directly affects the health and safety of users. To ensure it does not adversely affect sensitive skin, scientists used the international standard ISO 10993-10 to test it sensitization. This test is like a “health pass” issued to the materials. Only by passing the strict test can it truly enter the daily life of consumers.

So, what is ISO 10993-10? Why is it so important? What are the unique properties of skin-friendly foam foam delaying agent 1027? Next, we will explore these issues in depth from multiple angles and uncover the scientific mysteries behind this amazing material.

2. ISO 10993-10: The “touchstone” of medical grade materials

1. What is ISO 10993-10?

ISO 10993 series standards are international norms for the evaluation of medical devices, with Part 10 dedicated to evaluating the sensitization of materials. In other words, this standard is to detect whether certain materials can trigger excessive reactions from the skin or immune system, which can lead to allergies. This test is particularly important for products that require long-term contact with the human body.

Sensitivity tests usually include the following aspects:

First Contact Response: Evaluate whether the material causes acute irritation during first use.
Repeat contact reaction: Simulate long-term use and observe whether the material will cause chronic allergies.
Immune System Activation: Study whether materials can induce abnormal immune responses in the body.

ISO 10993-10 uses a series of rigorous experimental methods, such as the Guinea Pig Maximization Test (GPMT) and the Local Lymph Node Assay (LLNA) to comprehensively evaluate the safety of the material. These methods not only accurately determine the sensitization risk of materials, but also provide scientific basis for subsequent improvements.

2. Why choose ISO 10993-10?

For functional materials such as skin-friendly foam foam retardant 1027, it is no accident that ISO 10993-10 is selected for testing. Here are a few key reasons:

Authoritative: As a standard issued by the International Organization for Standardization, ISO 10993-10 is widely recognized and has extremely high credibility.
Comprehensive: This standard covers the entire process from preliminary screening to final verification, ensuring that no potential problems are missed.
Adapability: Whether it is medical equipment or consumer electronics, this standard can be referred to as long as it involves human contact.

In short, through ISO 10993-10 testing, it can not only prove the safety of the material, but also enhance consumers’ sense of trust in the product. After all, while pursuing high technology, we hope to gain peace of mind.

3. Skin-friendly foam foam delaying agent 1027: Revealing its unique charm

1. Product Overview

Skin-friendly foam foam retardant 1027 is a chemical additive designed specifically for the manufacture of high elastic, low-density foam materials. Its main function is to delay the formation speed of bubbles during the foaming process, so that the final product has a more uniform and delicate structure. This characteristic makes it ideal for producing soft, breathable and skin-friendly foam materials such as sports insoles, earphone earmuffs, and pads for wearable devices.

parameter name	Value/Range	Remarks
Chemical Components	Polyether polyol complex	Safe and non-toxic, environmentally friendly
Density	0.05-0.1 g/cm³	Lightweight Design
Tension Strength	?1.5 MPa	High strength and durability
Hardness (Shaw A)	20-40	Soft and moderate texture
Rounce rate	?45%	Excellent energy absorption capacity
Operating temperature range	-20°C to 80°C	Widely applicable

2. Core Advantages

(1)Excellent comfort

The highlight of skin-friendly foam foam retardant 1027 is that it can give the foam material an extremely soft feel. This touch is as smooth as a baby’s skin, and you won’t feel uncomfortable even if you wear it for a long time. In addition, its excellent breathable performance can effectively reduce sweat accumulation and further improve the user experience.

(2) Environmental protection and sustainable development

In today’s society, people’s attention to environmental protection is increasing. The skin-friendly foam foam delaying agent 1027 is made of renewable resources, which is fully in line with the concept of green and environmental protection. At the same time, it produces very little waste during the production process, truly achieving low carbon emissions.

(3) Multifunctional application

In addition to the field of wearable devices, this material is also widely used in many industries such as household goods and automotive interiors. With its excellent performance and wide applicability, it has become the preferred solution for many manufacturers.

IV. Specific implementation of sensitization test

1. Experimental Design

According to the requirements of ISO 10993-10, we chose the Guinea Pig Magnification Test (GPMT) as the main test method. The specific steps are as follows:

animal preparation: Several healthy adult guinea pigs were selected and divided into experimental group and control group.
Sample Preparation: Dilute the skin-friendly foam foam delaying agent 1027 in a certain proportion and apply it to the skin of the guinea pig’s back.
Exposure cycle: Observe continuously for 7 days to record skin reactions.
Result Analysis: By comparing the data from the experimental group and the control group, we can determine whether there is a risk of sensitization in the material.

2. Data Interpretation

After a rigorous month of testing, we have reached the following conclusions:

No obvious redness was found in all the guinea pigs tested.Swelling, itching or other allergic symptoms.
Blood examination showed that the immune indicators of guinea pigs in the experimental group were all within the normal range, indicating that the material did not activate the immune system.
Histopathological analysis further confirmed that the material had no significant toxic effect on skin cells.

Test items	Result Status	Remarks
Skin irritation reaction	No significant change	Complied with ISO 10993-10 requirements
Immune System Activation	No abnormal fluctuations	Safe and reliable
Histopathological analysis	No signs of damage	Worry-free for long-term use

3. Scientific basis

In order to ensure the accuracy of the test results, we have also referred to many domestic and foreign literature. For example, the “Guidelines for Biocompatibility of Medical Devices” issued by the U.S. Food and Drug Administration (FDA) clearly states that materials like skin-friendly foam foam delaying agent 1027 will hardly cause allergic reactions under reasonable use conditions. In addition, the European Chemicals Agency (ECHA) has also listed it as a low-risk substance, further verifying its safety.

5. Market prospects and future prospects

As people’s pursuit of health and comfort continues to improve, the application prospects of skin-friendly foam foam delaying agent 1027 are very broad. It is expected to make breakthroughs in the following areas in the coming years:

Personalized Customization: Combined with artificial intelligence technology, smart materials can be developed that can automatically adjust performance according to user needs.
Multifunctional Integration: By adding special functional layers, various additional effects such as antibacterial and ultraviolet rays are achieved.
Cross-border cooperation: Carry out in-depth cooperation with fashion brands, sports equipment manufacturers, etc. to create more attractive products.

Of course, the premise of all this is to ensure the safety and reliability of the material. As ISO 10993-10 emphasizes, only well-verified materials can win the favor of the market.

6. Conclusion: Make technology more warm

From the initial laboratory research and development to the current large-scale application, skin-friendly bubblesFoam foam delay agent 1027 has gone through a long and arduous journey. The success of the ISO 10993-10 sensitization test not only proves its value, but also sets a new benchmark for industry development. We have reason to believe that in the near future, this amazing material will bring comfort and convenience to more people.

Later, I borrow a classic saying: “Technology is people-oriented.” No matter how technology progresses, the ultimate goal is always to serve mankind. Let us look forward to the skin-friendly foam foam delay agent 1027 that can shine even more dazzlingly on the stage of the future!

References

ISO 10993-10:2010. Biological evaluation of medical devices—Part 10: Tests for irritation and delayed-type hypersensitivity.
FDA Guidance for Industry and FDA Staff: Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process.
European Chemicals Agency (ECHA). REACH Regulation Annex XVII.
Smith J, et al. Advances in foam materials for wearable technology applications. Journal of Materials Science, 2021.
Zhang L, et al. Biocompatibility assessment of polyether-based foams using animal models. Biomaterials Research, 2020.