美國標準：ASTM F1862《醫用口罩抵抗合成血液滲透的標準測試方法（已知速度下的固定體積水平投影）》

意義和用途

5.1 本測試方法提供了一種評估醫用口罩對合成血液滲透性的程序，可用于確定醫用口罩的抗滲透性能并對其性能進行排名。但是，該測試方法并未定義可接受的抗滲透水平，因為每個負責的用戶組織必須根據其自己的具體應用和條件進行此確定。因此，當使用此測試方法對醫用口罩的性能進行聲明時，必須描述進行測試的具體條件。

5.2 醫用口罩旨在抵抗血液、體液和其他潛在傳染性物質的飛濺或噴濺造成的液體滲透。許多因素都會影響體液的潤濕和滲透特性，例如液體的表面張力、粘度和極性，以及材料的結構和相對親水性或疏水性以及口罩本身的設計。血液和體液（不包括唾液）的表面張力范圍約為 0.042 至 0.060 N/m。7 為了幫助模擬血液和體液的潤濕特性，合成血液的表面張力被調整為接近該表面張力范圍的下限。合成血液的Zui終表面張力為 0.042 ± 0.002 N/m。

5.3 合成血液混合物采用紅色染料來輔助目測，并加入增稠劑來模擬血液的流動特性。合成血液并不總是能復制真實血液和其他體液通過防護服材料的極性，因此也不能復制其潤濕行為和隨后的滲透性。

5.4 在醫療過程中，血管偶爾會被刺破，導致高速血流沖擊防護性醫用口罩。沖擊速度取決于幾個因素，其中Zui重要的是患者的血壓。其他因素包括穿孔的大小和與穿孔的距離。由于大穿孔會導致壓力和速度迅速下降，因此未使用大穿孔來模擬本測試中考慮的血液飛濺速度范圍。此外，該測試方法基于以下假設：醫用口罩將靠近（300 毫米或 12 英寸以內）穿孔區域。因此，本測試方法的使用基于選擇合適的血壓、找到相應的血流或沖擊速度，并確定產生該血流速度的閥門時間，如附錄 X1 所示。

5.4.1 人體平均血壓一般在 10.7 至 16.0 kPa（80 至 120 mmHg）的范圍內變化。8 在該測試方法中，醫用口罩在對應于 10.7 kPa、16.0 kPa 和 21.3 kPa（80 mmHg、120 mmHg 和 160 mmHg）的流速下進行測試。

5.5 本測試方法允許使用其他非標準測試壓力、流速、流體量和樣品方向來評估與特定應用一致的醫用口罩抗穿透性。

5.6 本測試方法與測試方法 F1670/F1670M 的不同之處在于，本測試方法將 2 mL 合成血液噴灑到完整醫用口罩樣本的目標區域，而測試方法 F1670/F1670M 則要求防護服樣本在一小時內與合成血液持續接觸。測試方法 F1670/F1670M 中，一分鐘的暴露時間是在 13.8 kPa [2.0 psig] 的靜水壓力下。測試方法 F1670/F1670M 與使用微生物挑戰的測試方法 F1671/F1671M 結合使用，用于初步評估防護服對合成血液的抗穿透性。這兩種程序都旨在評估可能長時間接觸血液或其他體液并在壓力下工作的防護服。

5.7 本測試方法的用戶必須意識到，在提高醫用口罩對合成血液滲透的抵抗力和降低口罩材料上的壓降（作為醫用口罩透氣性的指標）之間存在一定的權衡。一般而言，提高醫用口罩的合成血液滲透抵抗力會導致相同設計和適合個人佩戴者的醫用口罩的壓降增加或透氣性降低。

5.8 This test method evaluates medical face masks as an item of protective clothing and does not evaluate medical face masks as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator must be used. This test method is useful to evaluate the resistance of a respirator to penetration by synthetic blood, if warranted.

5.9 This test method involves the preconditioning of specimen medical face masks in a relatively high humidity environment (85 ± 5?% relative humidity at 21 ± 5?°C [70 ± 10?°F]) to simulate the conditions of use when the wearer creates high humidity conditions by breathing through the mask. This preconditioning does not account for saturation of the interior medical face mask layer. However, additional pretreatment techniques in conjunction with this test method as described in 5.10 are permitted. Professional healthcare providers recommend that medical face masks be replaced when saturation occurs from breathing or from contact with other liquids.

5.10 Testing prior to degradation by physical, chemical, and thermal stresses which could negatively impact the performance of the protective barrier, could lead to a false sense of security. Consider tests which assess the impact of storage conditions and shelf life for disposable products, and the effects of laundering and sterilization for reusable products. The integrity of the protective clothing is occasionally compromised during use by such effects as flexing and abrasion.9 It is also possible that pre-wetting by contaminants such as alcohol and perspiration also compromises the integrity of the protective clothing. If these conditions are of concern, evaluate the performance of protective clothing for synthetic blood penetration following an appropriate pretreatment technique representative of the expected conditions of use.

5.11 While this test method involves a qualitative determination of the medical face mask resistance to penetration by synthetic blood under specific test conditions, it is possible to use this test method as a material quality control or assurance procedure.

5.12 If this procedure is used for quality control, perform proper statistical design and analysis of larger data sets when more than the required specimens are tested. This type of analysis includes, but is not limited to, the number of individual specimens tested, the average percent passing or failing, or both, with a standard deviation. Data reported in this way help to establish confidence limits concerning product performance. Examples of acceptable sampling plans are found in references such as ANSI/ASQC?Z1.4 and ISO?2859-1.

5.13 In the case of a dispute arising from differences in reported results when using this test method for acceptance testing of commercial shipments, conduct comparative tests between the purchaser and supplier to determine if there is a statistical bias between their laboratories. Competent statistical assistance is recommended for investigation of bias. At minimum, take a group of test specimens which are as homogeneous as possible and which are from a lot of the product of the type in question. Randomly assign test specimens in equal numbers to each laboratory for testing. Compare the average results from the two laboratories using a non-parametric test for unpaired data and an acceptable probability level chosen by the two parties before testing is begun. If a bias is found, either its cause must be found and corrected or the purchaser and the supplier must agree to interpret future test results with consideration to the known bias.

1. Scope

1.1 This test method is used to evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of synthetic blood penetration.

1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for face exposure and assess the appropriateness of this test method for their specific application.

1.3 This test method primarily addresses the performance of materials or certain material constructions used in medical face masks. This test method does not address the performance of the medical face mask’s design, construction, or interfaces or other factors with the potential to affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop). Procedures for measuring these properties are contained in Test Method F2101 and MIL-M-36954C.

1.4 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask. This test method evaluates medical face masks as an item of protective clothing. This test method does not evaluate the performance of medical face masks for airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask.

1.5 The values stated in SI units or inch-pound units are to be regarded separately as standard. The pressure values stated in each system are not exact equivalents. However, as the corresponding velocities are within 1?% of each other, (see X1.4.2), reporting of the results in either units is permitted.

1.6 本標準并不旨在解決與其使用相關的所有安全問題（如果有）。本標準的使用者有責任在使用前制定適當的安全和健康措施并確定監管限制的適用性。

1.7 本是根據世界貿易組織技術性貿易壁壘（TBT）委員會《關于制定、指南和建議的原則的決定》中確定的國際公認的標準化原則制定的。

測試項目測試名稱： ASTM F1862 合成血液滲透性醫用口罩抗合成血液滲透性測試方法

測試要求 測試要求： 

見下面報道摘要

Sample Size 樣品數量 / 送樣規格: 64pcs
Lead Time / TAT (Turn around Time) 測試: 周期服務 常規服務 15 個工作日

報告摘要 報告摘要: