E部分-手术器械
|
摘自FDA网站:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=878.4040
如有问题,请联系曼通客服021-51029925,或扫描下面二维码添加微信客服。
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] |
联系电话
021-5102-9925
在线客服
微信客服
(扫码添加微信客服)
2112257989
邮箱
始于2004年 专业FDA注册
立足上海 服务全国
推荐服务
>FDA注册认证:
>FDA合规服务
>体系合规:
>产品检测认证:
微信公众号
