#ISO10993

[eurofinsadvinus]

When a medical device interacts with blood, even minor surface changes can disrupt clotting—posing risks to both safety and regulatory approval. At Eurofins Safety Toxicology India , we understand what's at stake - That’s why our Coagulation Testing services are: ▶️ Scientifically rigorous and GLP-compliant ▶️ Built to align with ISO 10993-4 requirements ▶️ Designed to detect pro-coagulant or anti-coagulant responses early Whether you're developing a stent, catheter, or implantable system—ensure your innovation doesn't compromise the body’s natural clotting process. We deliver comprehensive #HemocompatibilityStudies to ensure precision testing and regulatory readiness.

[kapoorsalesindia]

Medical Grade PC Resin Supplier

Kapoor Sales Corporation is the authorized distributor of medical and healthcare Polycarbonate (PC) granules from SABIC Innovative Plastics. The #1 Medical Grade PC resin supplier has the maximum variety of Medical Grade PC resin certified for ISO10993 and USP class VI standards.

[liveon-biolabs-pvt-ltd-things]

[nicedayglobal]

Medical grade menstrual cup

Menstruation becomes simple easy

Up to standard ISO9001 & ISO10993

CN: 25.09.2021 15:00-17:00

GER/DE: 25.09.2021 09:00-11:00

https://watch.alibaba.com/v/72250cfb-dc88-4ffb-9d5f-f6abb47f7bfd?referrer=SellerCopy

#menstrualcup #menstrualhealth #menstruation #Period #women #beautiful

[formetechaus]

What Are The Benefits Of Plastic Medical Device Design?

Many medical fields are using Medical Device Design because of their durability, sturdiness, and various other benefits. If you are also looking for the best medical injection mould, it is time to explore its benefits and examine it.

So find it out right below.

Benefits

Cost-efficient: Using plastic moulding injection for medical devices is extremely economical than other materials, especially when you have to manufacture devices in high volume.

Accuracy: Accuracy is a must in medical devices. The difference of microns can make a huge difference. The plastic injections provide accuracy.

Material Options: With plastic injection moulding, you get a huge variety of material selection.

Durability:  The biggest reason to choose plastic injection moulding is its utmost durability. The devices made with Custom Plastic Moulding can resist various environmental factors and bear blunt forces without cracking, vibration, etc. In addition, these devices can easily bear constant sterilising chemicals or solutions. Hence, you can use these devices for a long time.

Anti-contamination: Another big benefit of using plastic injection mould for medical devices is the material is contaminant resistant and can be sterilised easily. Moreover, one can meet FDA and other requirements with these moulds.

What to Consider in Medical Plastic Injection Mould?

While choosing plastic injection mould for your medical devices, there are a few things that one must consider.

Read the major aspects right below:

FDA: FDA regulation defines the cleanliness and sterility of an object. In simple words, it defines how safe and prime a plastic item is. So it is crucial to see whether or not a plastic injection mould meets FDA standards and regulations. It will ensure that you are buying a high-quality plastic device, which will meet the medical-grade standard as well.

ISO: It is crucial that your medical devices acquire ISO certification, and the same implies to many industries. Any medical device must meet ISO 13485:2003 standard and compliance with Class I, II or III. Your devices must also meet biocompatibility – ISO10993 – in addition to some other standards. So if your medical device meets ISO standards, buy it without a second thought.

Medical aspects:

These are some crucial aspects that define whether or not a material is suitable for medical practices.

Explore those properties here:

Sterilisation properties: this is the minimum requirement because all medical devices come in contact with humans bodies. During the pandemic, it has become crucial to ensure that all medical devices are contaminant-resistant and will not spread the virus. This way, you can keep the patients safe.

Environment suitability: Some bio-implants must be suitable for the environment of the human body. They must be reliable to durability and operation when exposed to liquids, heat, vibration, corrosives, and various other movements. Many Medical Product Development agencies meet this environment suitability for making implants human-friendly.

That’s why you need quality Medical Device Design so that you can provide the right treatment to your patients and invest in the right place.

Find the biggest medical injection mould retailer in your area now!

Related: A Piece Of Information Of Medical Product Designs

[isabellagarci]

Medical grade LSR classification of medical silicone

Silicone is attracted by its stability and elasticity, so that the material can be cast into any shape. Today, various silicone materials meet the standards of medical device manufacturers, including medical non-implantable, medically restricted implantable and medically non-restricted implantable. One of the main reasons why silicone has developed into a key material for medical applications is the biocompatibility of the material and its use in various medical silicone products.      Innovations in material science have made it possible to use non-implanted materials for various hardness testers. This makes it possible to manufacture medical devices with different hardness levels. The non-implantable LSR used for mold manufacturing can be in contact with the skin, but not with the inside of the body. Medical silicone must be evaluated by specific safety tests. ISO10993 provides a global multi-part standard for evaluating the biological safety of this material. LSR complies with the medical application standard described in ISO10933.      Medical grade LSR is divided into three categories: limited exposure, prolonged exposure and sexual contact.      Limited Exposure-For equipment that will come into contact with skin, mucous membranes or damage and destroy surfaces, the service life of this category is shorter than 24 hours or less.      Prolonged exposure-This so-called "medical grade" material is based on tests such as hemolysis, genotoxicity, toxicity and histopathological intramuscular implantation. The material has surface or implant contact for more than 24 hours to 30 days.

[eurofinsadvinus]

Identify genotoxicity potential of your medical device with Eurofins Advinus. We have expertise in ISO 10993-3 & 33 genotoxicity biocompatibility testing & biological evaluation of medical devices. Raise your medical device testing query here: https://lnkd.in/eDKB93N

[kapoorsalesindia]

PC 144R Wholesaler

KSC is a dependable and proficient PC 144R wholesaler with proven capabilities to supply PC food grades granules with consistency. PC 144R food grade dana of virgin grade, available in natural, transparent, clear colors, is bio-compatible and assessed as per ISO10993 or USP class VI standards.

[liveon-biolabs-pvt-ltd-things]

BIOCOMPATIBILITY TESTING - LIVEON BIOLABS Pvt Ltd

#liveonbiolabs#biocompatibility#testing#medical#devices#ISO10993#guidelines#email#info#visit#website#connect#impeccable#journey#

For all your queries, feel free to contact us :

Email:info@liveonbiolabs.com

Visit our WEBSITE:www.liveonbiolabs.com

[latteyuko]

・ ・ ⛄️平成最後の冬⛄️ ・ ・ 本当に自分でもビックリ👀するのだけど、 2018年は資格を取りまくった年でした。 夏・秋・冬と夕美先生には色々お世話になった年でした。 ・ 何よりも1番資格を取りたかったボディジュエル💎💎💎 平成最後の冬に、2018年最後の12月に取得しちゃいました✌️ ・ ・ ・ ・ 🎀ユリシス3Dボディジュエル・アーティスト🎀 ・ ・ 素肌に繰り返し貼ることが出来る新感覚のアクセサリー💍 ・ お好きなストーンとグリッターを使って、 素敵なボディジュエリーを作ってみませんか？ ・ ユリシス独自開発をした【ユリシスシート】なので、 お肌に安心・安全、機能性も抜群なアクセサリーです。 国際基��であるISO10993医療機器の生物学的評価の基準した素材のため、 お肌が敏感な方や弱い方、小さいお子さんでも安心してお使いできます。 ・ また素肌だけではなくデコ素材などとしてもお使い頂けます。 ・ デザインも豊富ですよ。 その内･･･販売もしたいと思っておりますので。 ・ ・ 自宅サロンになりますが、体験レッスンを承っております。 （※場合によっては出張（東京23区内）も可です。） ・ ・ お気軽にお問い合わせ下さいな。 ・ ちなみに写真のバタフライ・3Dボディジュエリーですが、 本当は赤が大好きな私。 だけど、、、 自分のオーラカラーを調べてもらったら緑だったので、 あえて緑で作ってみちゃいました。 ・ ・ #ユリシス3dボディジュエリー#ボディジュエリー#3dボディジュエル#ボディジュエリーレッスン#ボディジュエルレッスン#キラキラ#オーラカラー#自宅サロン#東京自宅サロン#墨田区自宅サロン#墨田区#大人可愛い#ハンドメイト#体験レッスン#副業#お稽古 https://www.instagram.com/p/BsPiFo7l5gY/?utm_source=ig_tumblr_share&igshid=10z6kcmfwufzt

[gracdsohler-blog]

thermal conductivity test

After years of wear and tear, a house falls out of balance. Uncontrolled air flow causes drafts, making rooms too hot or cold. Air begins to enter around windows and door frames, through cracks and outdated plumbing. Before long, a house may suffer peeling paint, soot deposits, a rotting roof, stuffy air, mold or mildew, foggy windows and lingering odors. These problems can lead to allergies, danger from carbon monoxide and other long-term health hazards for occupants.

When a house's performance is out of whack, the building looses energy, which translates into higher energy bills. Building performance attempts to get a house or office building back thermal conductivity testing services  in balance. The term refers to a set of measurable building characteristics that include: durability, moisture management, energy efficiency, indoor air quality, structural performance and thermal comfort.

"Building science," also known as "building performance," grew out of an interest in improving our quality of life and halting climate change through adjustments to our built environment. Both fields developed as a result of scientific research over the past 15 years analyzing how homes and buildings function. The U.S. Department of Energy and U.S. Environmental Protection Agency conducted much of this research following an increase in building-related problems, such as sick-building syndrome, the presence radon (a toxic chemical), rising energy costs, a doubling of childhood asthma, and growing public support for sustainable building.

Professionals in the building-performance industry understand the holistic interaction of a building's systems, including materials, insulation, airflow, heating and cooling design, and more. They use diagnostic tools to examine a house's interactive system. The goal of these tools: stop moisture damage, prevent health hazards, improve insulation, and check heating and cooling systems for efficiency and safety.

These professionals understand the importance of the overall performance of a building envelope and look at the house as a whole system. These workers: inspect mechanical ventilation systems; conduct carbon monoxide and indoor-air quality analysis; diagnose HVAC air distribution and combustion; test thermal imaging and pressure; conduct insulation, window and lighting analysis; figure out how to repair drafts; and determine cost-effective methods for reducing energy loss.

One of the most important methods for making a home more comfortable, healthy and affordable is weatherization. This process involves weatherproofing or protecting a building from outside elements, such as sunshine and heat, rainfall, wind and frigid air. Weatherization lowers energy consumption and optimizes energy efficiency. When homeowners weatherize their houses, they achieve immediate energy savings, while preventing greenhouse-gas emissions that contribute to climate change. Biocompatibility is a measurement of how compatible a device is with a biological system (not generating any local or systemic responses from a living system or tissue). In the simplest sense, a biocompatible material or device does not harm the patient. From a regulatory view, it is a series of tests that are used to determine the toxicity resulting from contact of the parts of medical devices or combination products with the body.

A medical device may consist of materials that are biocompatible, although the device itself requires biocompatibility testing and all testing is performed on the final product.

ISO Standard for Biocompatibility Testing:

Common biocompatibility testing, such as those described by ISO 10993, is conducted prior to clinical evaluation of the device or clearance to market the product. This testing involves analysis of the device if non-toxic and non-allergic as per ISO 10993 standard. The purpose of this testing is to determine the fitness of a device for human use, and to check whether the device can have any harmful physiological effects.

Implementation of ISO10993 varies, based on the risk associated with the use of the product. Many of the biological screens that comprise the remaining parts of ISO 10993 are designed to estimate specific aspects of biocompatibility, and therefore are not required for all medical devices.

ISO:

ISO was established to determine a uniform worldwide standards and it is a non-governmental network of national standards institutes and acting as a bridge between the private and public sectors. International Organization for Standardization is abbreviated ISO from the Greek word "isos" meaning equal.

[jetsoday]

新港牌 Gimans Care 推 Level 2 彩虹口罩 Ω 型立體構造更透氣!

新港牌 Gimans Care 推 Level 2 彩虹口罩 Ω 型立體構造更透氣! http://hkmask.likehour.com/hk-face-mask-news/%e6%96%b0%e6%b8%af%e7%89%8c-gimans-care-%e6%8e%a8-level-2-%e5%bd%a9%e8%99%b9%e5%8f%a3%e7%bd%a9-%cf%89-%e5%9e%8b%e7%ab%8b%e9%ab%94%e6%a7%8b%e9%80%a0%e6%9b%b4%e9%80%8f%e6%b0%a3/ 新香港口罩牌子 Gimans Care 將正式開賣口罩，廠方也是以彩虹口罩作賣點。    Gimans Care 表示，為日本 Starday 口罩之授權批發銷售商，擁有多年口罩經銷經驗。其廠房已有十 多年口罩生產經驗，符合 ISO13485 醫療器材品質管理系統標準及 ISO10993 生物相容性試 驗，生產過程管理及產品質量方面都達到國際標準水平 Gimans Care 彩色口罩符合 ASTM 第 2 級防護標準及 EN14683 Type IIR，細菌過濾率（BFE）、 粒子過濾率（PFE）及病毒過濾率（VFE）均達到 99%或以上，即口罩能有效過濾微粒及細菌 達 99%以上。 Gimans Care 彩色口罩現有檸檬黃及晴空紫藍兩色，口罩採用獨特「Ω 型」立體構造，讓口鼻與口罩間留有更多空間，確保口罩在炎熱的夏天亦能舒適佩戴，七月起將提供薰衣草紫、蜜柑橙及玫瑰粉紅三色可供選擇。Gimans Care 彩色口罩共 有三款不同尺寸 17.5cm x 9.5cm（成人）、14.5cm x 9cm（中童）及 12.5cm x 8cm（幼童）， 以滿足不同年齡層及臉型之需要。 Gimans Care 口罩的正式零售價格將稍後公布，但早前廠方曾在 FB 作搶先銷售 ，標準成人日式立體型 50 個裝售 $138 起。

[chiu1111-blog]

緊鄰著廠房的是幾十位「老寶貝」──伸臂向天，以綠蔭為人

從傳統貿易走向尖端科技

一九九六年，尤利春開始學佛，佛教經典的啟發，改變了他的人生價值觀， 更強化利潤共享的信念。他認識到，世間一切都���因緣聚會，無論善緣、惡緣都要去完成、善了，生命該承擔的就要去承擔。以前他專注事業，照顧家人和員工，現在公司漸入佳境，尤利春的經營理念，也從賺錢、共好，擴及對社會的責任。

關照眾生、關照地球的想法愈來愈強烈，此時，他間接接觸到「電子架橋環保泡棉」的尖端技術，這項技術可用來製造無毒、穩定性高，而且環保的發泡材料，正好符合尤利春以友善產品回饋社會的理念。

然而，從傳統貿易跨足新科技並非易事，尤利春的膽量從何而來？

「這是環境友善產品，如果大家都來使用，就是幫地球、幫人類、幫助生生不息的物種。只要是利益眾人的事，多辛苦我都願意承擔，」尤利春理所當然的指出。

面對「責任」，他向來勇往直前。正是這樣的理念與因緣，促成尤利春在一九九九年，從國外引進電子加速器照射設備，正式跨足先進越南文翻譯的高分子照射架橋技術。

「電子架橋」是非常領先的技術，在當時，全世界只有日本少數幾家廠商在研發，對台灣仍是相當陌生，對於從事傳統產業的尤利春來說，更是一個全新的領域。

面對不熟悉的尖端技術，尤利春在公司成立研發中心，並與工業技術研究院、紡織產業綜合研究所、國家中山科學研究院等多處機構進行產、官、學、研合作， 共組虛擬研發團隊，並同享研發成果。

「我們希望大家共襄盛舉，把這個泡棉推廣至全世界。我們的目標並非賺最多錢或做最大企業，而是能讓更多人使用對地球友善的產品，」尤利春說。

一場大火的試驗越南文翻譯

就在新事業如旭日東升般蓬勃開展之際，一把突如其來的大火瞬間吞沒廠房。好不容易火滅了，但眼前只剩一團焦黑的機器和泥牆，尤利春的壯志豪情消減了大半，他無奈的自嘲，「我一生必須承擔的責任，應該了了吧��這是上天叫我不要做吧？！ 」

原本的多項計畫因這場大火戛然停止，跟了多越南文翻譯年的員工也不得不忍痛遣散， 尤利春感到意興闌珊。

這時，負責生產營運的小兒子尤淳永鼓勵他，「這是老天爺給的功課：我們在哪裡跌倒，就要在哪裡站起來！」一句話敲醒了尤利春，他被兒子的堅持激勵，廠房再度動了起來。

從承擔個人命運到承擔社會責任，每一次轉折，都讓尤利春更堅強。因為堅定的責任感，走到絕境也能踏出新路。越南文翻譯

二○一一年，尤利春創立了泉碩科技，引進日、韓最新泡棉生產設備，同時持續發展環保、高功能紗線及紡織品，整裝重新出發。

雖然創業維艱，尤利春仍堅持公司要持續進步，每年提撥一定金額投入研發， 務求產品不斷升級，這也是泉碩不到十年，就躋身世界前三大環保泡棉商的重要原因。

以醫療用品級泡棉服務各領域客戶

泉碩的環保泡棉「伊特龍eFoam」，在隔熱、越南文翻譯防水、避震、隔音、防潮、抗菌、防電磁波等功能上，均有優於傳統泡棉的絕佳效果。

尤利春比較兩者的隔熱功能，「一般的泡棉會吸收空氣中的水分，而大幅降低隔熱係數，造成泡棉崩解，失去作用。但是伊特龍因為獨越南文翻譯特的密閉式泡孔結構， 不會吸收水分，因此隔熱功能長年穩定。」

尤利春更是如數家珍說著伊特龍的優點：物理方式生產，所以無毒無臭，製程清潔無汙染；而且耐用年限長達三、四十年，可以有效降低資源消耗。

伊特龍不僅通過國內環保署第一類和第二類環保標越南文翻譯章、SGS無毒證明，更符合歐盟RoHS 規範標準(無重金屬)、REACH 法規，並獲美國第一家產品安全標準發展與認證機構保險商實驗室(Underwriters Laboratories Inc, UL)認證。伊特龍得到的種種肯定中，有一個特別的指標，就是ISO10993 醫療器材生物性評估測試，越南文翻譯這意味著，伊特龍是醫療用品等級的泡棉。

尤利春自豪的表示，公司並不會因客戶的��途不同，而供應不同等級或品質的泡棉，因為穩定一致的品質，是泉碩一貫的堅持。越南文翻譯

從生產線著手，由專業的技術團隊重組進口設備，尤利春開心的指出，「我們藉由技術和產品的再升級，提升價值和服務，已經成功將伊特龍導入建材、電子產業、民生、醫療、運動用品、鞋材、車材等領域。」

以尖端技術生產環境友善泡棉，讓尤利春對新科技產生信心，他以數年時間， 致力發展兼具環保及功能性的紗線及紡織品，越南文翻譯近年來終於交出亮麗成績單， 那就是染色堅牢度佳，又可大幅降低所需染色劑、縮短染色時間的「節能減碳亮彩紗」，這項產品已在全球多個國家申請專利。

共生、共榮、還要共好！

在泉碩的三峽廠區，緊鄰著廠房的是幾十位「老寶貝」──伸臂向天，以綠蔭為人遮陽的六百年老樹，這些樹因為土地開發而面臨被砍伐的命運，被尤利春及時搶救回來。他請專家移栽、重植，光是讓這些老樹異地再續生命，往越南文翻譯往就要花上幾百萬、幾年的時間。

曾經的苦難像是颶風，尤利春站在颱風眼的中心位置，雖然辛苦，也是幸運， 得以吸取各方能量，更加茁壯，如今，各級學校、廟宇佛寺、弱勢家庭，都可見尤利春樂善好施的身影，他就像是守候泉碩廠區的大樹，越南文翻譯沉穩、內斂、枝繁葉茂卻不吝為人們提供遮蔭、容納各種生物棲息，這正是尤利春一生的寫照。

共生、共榮、還要共好！

[lindazhao]

All ROMEO condoms inspection level is higher than international level

All ROMEO condoms are manufactured confirm to ISO4074 and latest WHO specifications. We use the quality natural latex and add into the qualified vulcanization, promoter, ageing-resistant. Through the process of beforehand vulcanization, shaping and back vulcanization. All the products are electronically tested. After passed the test of pinhole leakage, mechanic and air burst, the products will be packaged in airtight condition. The testing results of condoms according to ASTM D3492, EN600, WHO GPA/TCO/PRV, GB7544. The result identify that the inspection level achieve the international level. All ROMEO condoms have been tested in conformance with the following test methods of ISO10993 Biological Evaluation of Medical Devices. When evaluated as per this standard, the condom is not toxic (local or Systemic), sensitizing, locally irritating or otherwise harmful. All ROMEO condoms are a thin, elastic sleeve to cover the penis during intercourse to prevent fertilization. Welcome to inquiry high quality ROMEO condom. Email: linda@oemcondoms.com

Tags:

[zahnsply-blog]

#ZahnSply® #Metabiomed #MDFlex #PolyvinylsiloxaneImpressionMaterial Applications: Cavity impression of veneer, inlay, onlay Impression of crown or bridge, partial denture Advantages: Impression of crown or bridge, partial denture. Accurate impression without bubbles because of hydrophilic property. Gypsum model will be effectively reproduced Without transformation due to an excellent reproducibility and volume stability. Biocompatibility. (ISO10993) This product is compatible with other Polyvinylsiloxane Impression Materials. Easy to mix by auto-mixing type. ( 450ml Base, 450ml Catalyst.) Shelf life Two years from the production https://zahnsply.com/metabiomed-en/md-flex.html

[eurofinsadvinus]

Our specialists can help with studies to identify the biocompatibility of implantable medical device as per ISO 10993-6. Raise your testing query here: https://lnkd.in/eDKB93N