T/GDTEX 10-2020 Active Group standards

T/GDTEX 10-2020 Guidelines for enterprises to invest (transfer) production of medical disposable protective suits

Publish Date: 2020-03-28 Implement Date: 2020-03-30 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/GDTEX 10-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Light industry, culture, and daily necessities

ICS Name: Clothing

Publish Date: 2020-03-28

Implement Date: 2020-03-30

Scope

Scope: This standard provides the terms and definitions, general principles, and work procedures for enterprises converting to the production of disposable medical protective clothing in Guangdong Province. This standard applies to all enterprises in Guangdong Province converting to the production of disposable medical protective clothing. This standard does not apply to the conversion to the production of daily work clothes, disposable surgical gowns, or medical isolation gowns. Main technical content: 1. Scope: This standard provides the work procedures and guidance information for enterprises converting to the production of medical protective clothing. This standard applies to all enterprises in Guangdong Province converting to the production of medical protective clothing. This standard does not apply to the conversion to the production of daily work clothes, disposable surgical gowns, or medical isolation gowns. 2. Normative references: According to the requirements of GB/T 1.1, this standard cites the following provisions of the "Administrative Measures for Medical Device Registration" (Decree No. 4 of the National Medical Products Administration): Article 15 and Article 17; and cites the "Quality Management Code for Medical Device Production" (Announcement No. 64 of 2014 by the National Medical Products Administration) Article 11. 3. Terms and definitions: This standard defines disposable medical protective clothing as follows: It refers to Class II medical devices used by medical personnel and people entering specific areas to prevent the transmission of potentially infectious blood and bodily fluids, and to prevent bacteria and viruses from penetrating. 4. Work procedures 4.1 Preparation phase 4.1.1 Qualification application: As Class II medical devices, applicants must first obtain a valid and legal business license from the local municipal or county-level market supervision and management departments, and then proceed to the provincial market supervision