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第878部分-常规和塑料外科设备

E部分-手术器械

 878.4040外科服装。

(a)识别。 外科服装是旨在在手术过程中由手术室人员佩戴的装置,以保护手术患者和手术室人员免受微生物,体液和颗粒物质的转移。示例包括手术帽,头罩,口罩,工作服,手术室鞋和鞋套以及隔离口罩和工作服。不包括外科手术服和礼服,通常称为磨砂服。

(b)分类。 (1)手术服和手术口罩II类(特殊控制) 如果N95外科口罩或N95过滤式面罩呼吸器旨在预防特定疾病或感染,或者被标记或以其他方式表示为过滤外科手术烟雾或烟气,过滤特定数量的病毒或细菌,减少以下疾病的数量和/或杀死病毒,细菌或真菌,或影响变应原性,或包含与过滤无关的涂层技术(例如,减少和/或杀死微生物)。手术N95呼吸器和N95过滤式口罩呼吸器不受本章807部分E小节的上市前通知程序的约束,但要遵守878.9的以下条件:

(i)必须证明用户接触设备的组件具有生物相容性。

(ii)分析和非临床测试必须:

(A)具有易燃性,并证明适合于预期的使用环境;

(B)证明设备以与设备的预期用途一致的速度抵抗流体(例如血液和体液)渗透的能力。

(iii)NIOSH根据其法规获得批准。

(2)除手术服和手术口罩以外的手术服装的I类(常规控制) I级设备不受本章807部分E小节中的上市前通知程序的约束,但适用于878.9。

[1988年6月24日修订为53 FR 23872,2000年1月14日修订为65 FR 2317;83 FR 22849,2018年5月17日]



摘自FDA网站:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=878.4040

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PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES

Subpart E--Surgical Devices

Sec. 878.4040 Surgical apparel.

(a) Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

(b) Classification. (1) Class II (special controls) for surgical gowns and surgical mask s. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 878.9, and the following conditions for exemption:

(i) The user contacting components of the device must be demonstrated to be biocompatible.

(ii) Analysis and nonclinical testing must:

(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and

(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.

(iii) NIOSH approved under its regulation.

(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical mask s. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 878.9.

[53 FR 23872, June 24, 1988, as amended at 65 FR 2317, Jan. 14, 2000; 83 FR 22849, May 17, 2018]