T/XMSA 001-2022 Active Group standards

T/XMSA 001-2022 Medical isolation mask (face shield)

Publish Date: 2022-12-20 Implement Date: 2022-12-25 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 20.00

Out of stock

Basic Information

Standard Code: T/XMSA 001-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Labor protective gear

ICS Name: Head protection equipment

Publish Date: 2022-12-20

Implement Date: 2022-12-25

Scope

Scope: This document specifies the terms and definitions, structure and materials, technical requirements, test methods, inspection rules, user manuals, labels, packaging, and storage requirements for medical isolation eye (face) masks. This document applies to hard protective masks (face shields) made of polymer materials, consisting of foam strips and fixing devices. They are provided non-sterile and for single use. They are used in medical institutions to provide protection during examinations and treatments, blocking bodily fluids and blood splashes. This document does not apply to ordinary protective glasses that are not regulated as medical devices. Main technical content: 5. Technical requirements 5.1 Appearance 5.1.1 The surface of the lens (face shield) should be smooth, free from scratches, wrinkles, bubbles, impurities, or other obvious defects that may impair vision. 5.1.2 The surface of the protective shield should be smooth, free from burrs, and sharp corners, and should not have ventilation holes. 5.1.3 The surface of the foam strips should be smooth and free from burrs and sharp corners. 5.1.4 The fixing straps should have good elasticity and be easy to adjust. 5.2 Dimensions 5.2.1 The lenses and protective shields should be designed according to the size requirements of GB/T 2428-1998 "Adult Head and Face Dimensions", and the dimensions of the batch production samples should meet the design requirements. 5.2.2 The thickness of the protective face shield should be 0.2 mm to 0.4 mm. 5.3 Material compatibility The parts in contact with the wearer should have good biocompatibility, no potential cytotoxicity, no skin irritation, and no skin sensitization reaction. 5.4 Performance of fixing straps 5.4.1 The width of any part in contact with the wearer should be ≥10 mm. 5.4.2 Elongation rate The elongation rate should not be less than 50%, and the fasteners should not fall off under test conditions. 5.4.3 Strength of connection The connection should