Medical protective clothing standards in key countries and regions
Time: Oct 22, 2021

According to the Announcement No. 53 of the General Administration of Customs of China in 2020, starting from April 10, medical supplies under 11 categories and 19 types of customs commodity codes will be subject to export commodity inspections. The testing of exported medical materials by customs laboratories will be conducted in accordance with the following standards: if the importing country (region) has quality and safety standards, the testing will be conducted in accordance with the quality and safety standards of the importing country (region); the importing country (region) does not require quality and safety standards Yes, it shall be tested in accordance with my country's quality and safety standards.

Below, let us understand the respective implementation standards and related certification and accreditation requirements of China, the United States, and the European Union for medical protective clothing.

Standard Overview

Chinese medical protective clothing implements the national standard GB 19082-2009 "Technical Requirements for Medical Disposable Protective Clothing", which is mandatory. For medical disposable non-woven protective clothing, there is no provision for reusable protective clothing.

The American medical protective clothing standard is NFPA1999 formulated by NFPA (American Automobile Fire Protection Association), which is applicable to AAMIPB-70 formulated by the American Medical Device Development Association during medical emergencies, and is suitable for evaluating the barrier performance of sanitary protective clothing.

The European Union has promulgated the performance requirements and test methods of EN14126-2003 protective clothing and anti-virus protective clothing. The main focus of this standard is the resistance of protective clothing to blood, body fluids and virus penetration.

Certified Product


Domestic medical devices are usually divided into three categories based on risk: First, the ones with low risk and those with basically no risk belong to one category, and they are filed with the drug regulatory authority of the local city bureau. Second, medium-risk medical devices are registered and approved by the provincial drug regulatory authority. Third, high-risk medical devices belong to the third category, and the national bureau is directly responsible for organizing approval.

Medical protective clothing belongs to the second category of medical devices, and is registered and managed by the provincial drug regulatory authority.


The U.S. Food and Drug Administration (FDA) divides medical device products into three levels for management according to the risk level. The first level refers to ordinary products, the second level refers to products whose safety and effectiveness are guaranteed through special controls, and the third level refers to products that ensure their safety and effectiveness through special controls. Products generally used to support human life, prevent damage to human health, and have potential unreasonable risks of curing diseases and disability.

US medical protective clothing can be divided into non-surgical protective clothing and surgical protective clothing. Non-surgical protective clothing is a Class I medical device, which is exempt from pre-market registration and directly registered with the institution. Surgical protective clothing is a Class II medical device and requires pre-market registration, that is, an FDA 510K application is required.

3. European Union

Commodities related to safety, health, environmental protection and consumer protection (such as electronics, machinery, medical equipment, toys, personal protective equipment, communications, pressure equipment, etc.) in the EU Economic Area market have been compulsorily listed as "must carry CE mark, otherwise it is not allowed to enter the EU market circulation" list.

Protective clothing belongs to personal protective equipment. The English name is Personal Protective Equipment, or PPE for short. The EU's personal protective equipment safety directive is 89/686/EEC. According to the provisions of the PPE Directive, PPE products are divided into three categories according to the complexity and protection level of the PPE product design. Personal protective equipment sold in the European market must meet applicable safety requirements and standards.

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