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2021-05-09 21:31:27

2021年4月1日，英国政府发布透明口罩技术规范的更新。

介绍

本规范给出了一次性透明口罩的设计和性能要求，该口罩旨在使用现有标准中的试验方法和性能要求，基于IIR型医用口罩的部分或全部性能提供类似的保护和源头控制，同时根据透明度的要求对其进行调整。

许多临床和患者群体将受益于医用口罩的透明版本，这些人包括聋人保健工作者、聋人患者、言语和语言治疗师，以及与心理健康问题、认知障碍（痴呆症）和学习障碍患者打交道的保健工作者。作为本规范主题的透明口罩主要意图作为上述场合使用的医用口罩。

Face masks in healthcare can be used both for source control (worn by an infected individual to prevent onward transmission to others via droplets) and for protection of healthy persons (to protect the wearer from droplets and splashes when exposed to an infected individual).

Many patients, service users and healthcare workers have requested a transparent version of a face mask. A transparent face mask can support communication between those who have hearing difficulties or are deaf, patients/service users with cognitive problems such as dementia, and those with learning disabilities

设计要求

符合本规范的口罩通常包括一个透明区域，根据唇读或其他面部可见度要求，该区域允许佩戴者的嘴和面部区域对其他人可见。该区域可以连接到过滤区域或固定到泡沫条等柔性材料，有助于口罩的透气性。

透明口罩在使用过程中不应解体、裂开或撕裂；应能够紧密地佩戴在使用者的鼻子、嘴巴和下巴上；口罩佩戴就位时，必须避免使用者声音的显著失真或音量降低；透明口罩的整体设计必须确保佩戴者在预期使用期间能够舒适地呼吸；不可装配呼吸阀。

透明口罩可能有不同的形状和构造以及附加的特征，例如面罩（保护佩戴者免受飞溅和水滴的伤害）或鼻梁条（通过符合鼻子轮廓来增强贴合度）。

用于特定用途（如语音和语言评估）的透明口罩应满足这些用户的要求-例如，允许足够的面部视角以适应面部运动，而无需滑动或移动口罩。本规范中未涉及特定用途口罩的其他设计要求。

Masks complying with this specification will generally include a transparent area, which allows the wearer’s mouth and areas of the face to be visible to others, as required for lip reading or other facial visibility requirements. This area may be attached to or surrounded by a filter area or a flexible element (such as a foam strip) which seats the mask to the face. The mask or seating element may include air gaps to aid breathability, which are oriented in the opposite direction to which the wearer is facing.

Other design combinations may be acceptable, as long as they achieve the same level of source control and wearer protection performance. The mask shall not disintegrate, split or tear during intended use.

The transparent face mask shall have a means by which it can either be fitted closely over the nose, mouth and chin of the wearer and which ensures that the mask fits closely at the sides, or by which it sufficiently covers the nose, mouth and chin, in a manner which ensures adequate source control and wearer protection.

Transparent face masks intended for specific uses (such as speech and language assessments) should also meet the requirements of those users – for example, allowing an adequate view of the face to accommodate facial movement without slipping or displacing the mask.

The transparent face mask must avoid the significant distortion or reduction in volume of the voice of the user when the mask is in place.

The manufacturer must ensure that the transparent face mask does not restrict breathing of the wearer.

Transparent face masks may have different shapes and constructions as well as additional features such as a face shield (to protect the wearer against splashes and droplets), or a nose bridge (to enhance fit by conforming to the nose contours).

The overall design of the transparent face mask must be such that the combination of filter area, seating element and air gaps ensures that the wearer can breathe comfortably for the duration of intended use.

Transparent face masks shall not contain any valves.

There may be other design requirements important to specific users which are not dealt with in this specification.

包装和标签

符合本技术规范的口罩：

(1) 应按照适合的规定进行标记、贴标签和包装;

(2) 明示仅为一次性使用；

(3) 不得标记为IIR型医用口罩。

制造商还应考虑使用EN ISO 15223-1:2016和EN 1041:2008+A1:2013中规定的适当或公认的符号和信息（取决于制造商提出的声明）。

Masks complying with this technical specification:

shall be marked, labelled and packaged in conformance with the appropriate regulations

shall be labelled as single use only

shall not be labelled as Type IIR medical masks

The manufacturer should also consider the use of appropriate or recognised symbols and information as specified in EN ISO 15223-1:2016 and EN 1041:2008+A1:2013, for example (depending on the claims the manufacturer is making).

材料要求

透明口罩所用材料应适合在产品设计的预期使用期间承受搬运和磨损能外力作用。材料性能需要满足如下要求：

Materials used shall be suitable to withstand handling and wear over the period for which the transparent face mask is designed to be used.

Materials must also comply with the biocompatibility requirements.

Attention shall be paid to cleanliness in the selection of materials.

生物相容性

对直接接触皮肤、鼻子和嘴巴的口罩材料进行评估。

Parts of the mask which come into direct contact with the skin, nose and mouth shall be assessed against BS EN 14683:2019+AC:2019, section 5.2.6 (biocompatibility).

过滤效率

1. 透明口罩的过滤区域面积和透明区域的细菌过滤效率(BFE)应≥ 98%，相当于BS EN 14683:2019+AC:2019中规定的IIR型医用口罩的过滤要求；

2. 如果不能按照BS EN 14683:2019的附录B对透明区域进行测试，则按照BS EN ISO 22610:2006(阻湿态微生物穿透试验方法)进行屏障指数的测定。也可采用其他标准化和公认的试验方法进行测试，以证明其抗微生物渗透的能力，例如ASTM F1671(阻phi-X174噬菌体渗透试验方法)。

3. 无过滤区域的透明口罩，仅根据BS EN ISO 22610(阻湿态微生物穿透试验方法)进行测试。

The filter area and transparent area of a transparent face mask shall have a bacterial filtration efficiency of ≥ 98%, equivalent to that specified in BS EN 14683:2019+AC:2019, section 5.2.2 and 5.2.7 for Type IIR medical masks.

If the transparent area cannot be tested to Annex B of BS EN 14683:2019, it shall, when tested to the wet bacterial penetration test in BS EN ISO 22610:2006 (test method to determine the resistance to wet bacterial penetration) have a barrier index (IB) = 6.0. Alternately, it may be tested to other standardised and accepted test methods designed to demonstrate resistance to penetration of microorganisms – for example, ASTM F1671.

For masks with no filter area or which use seating materials impervious to the passage of air, test to BS EN ISO 22610 only.

There are 2 methods to assess the filtration efficiency:

if a mask consists of 2 or more areas with different characteristics or different layer-composition, each area can be tested individually

alternatively, it is acceptable to test a combination of the filter area and transparent area together, to assess the combined filtration efficiency –this can be achieved by placing adjacent areas over the test apparatus orifice, with approximately half of each material covering the orifice, and the join/seam running through the centre

呼吸透气性

用于透明口罩过滤区域的材料透气性应满足BS EN 14683:2019中对IIR型口罩的压差的要求(<60Pa/cm2)。

The filter area material used for transparent face masks shall not exceed the differential pressure requirements for Type IIR masks in section 5.2.3 in BS EN 14683:2019.

防喷溅

透明口罩过滤区域和透明区域对液体飞溅的渗透阻力应符合BS EN 14683:2019中IIR型医用口罩的要求(>=16kPa)。

The resistance of the filter area and transparent area of the transparent face mask to penetration of splashes of liquid shall conform to the minimum value given for Type IIR in Table 1 of BS EN 14683:2019 when tested to ISO 22609:2004.

微生物清洁度(生物负载)

透明面罩的生物负载应符合BS EN 14683:2019的要求(≤ 30cfu/g)。

When tested according to section 5.2.5 in BS EN 14683:2019, the bioburden of the transparent face mask shall comply with the requirements of Table 1 Section 5.2.7 in BS EN 14683:2019.

能见度

透明区域应符合BS EN 166:2002(个人眼睛防护设备一般说明)第7.1.3节(材料和表面质量)以及第7.3.2节(目镜抗雾性)的要求。

The transparent area shall comply with BS EN 166:2002, section 7.1.3 (quality of material and surface) and section 7.3.2 (resistance to fogging of oculars).

The transparent area shall allow the wearer’s lips, mouth and areas of the face to be visible to others, as required for lip reading or other facial visibility requirements.