Surgical gowns and isolation gowns

Regarding the question "Is the gown specified in EN13795-1 necessarily of the surgical gown type? Can the isolation gown be of a different style as long as it uses the same raw materials and heat-sealing process?"

The following are the specific analyses and suggestions / Core Difference / Standard Definition and Application:

1. The positioning of EN 13795-1 standard:

   The full name of this standard is "Surgical Gowns and Clean Air Gowns". Its core purpose is to set requirements for protective clothing used in high-risk and high-demand environments such as operating rooms.

   The standard clearly distinguishes between "surgical gowns" and "clean air gowns". It does not include "isolating gowns" as a product category that complies with this standard.

2. Key differences / design structure and coverage area between "surgical gown" and "isolating gown":

   Surgical gown: Designed for sterile areas. It typically requires covering the entire upper body, arms up to the wrists, and having sufficient overlap on the back. The closure methods of the collar, cuffs, and waist have specific requirements to maintain the sterile barrier throughout the surgery.

   Isolating gown: Designed for non-sterile operations or general protection (such as visiting patients, general nursing, isolation protection). Its design is usually simpler, with lower requirements for coverage, cuff closure, and waistband closure compared to the surgical gown. The main purpose is to prevent the splashing or contact transmission of liquids and microorganisms, rather than maintaining a sterile state for a long time.

Performance testing requirements:

EN 13795-1 imposes extremely strict requirements for the key areas of surgical gowns (such as the front part and sleeves), including liquid barrier properties (water resistance), microbial barrier properties (both dry and wet conditions), breathability, and anti-slip shedding. These requirements are divided into different performance levels.

Isolation gowns may follow other standards (such as EN 13795-2, or as Class I medical devices), and their performance requirements, especially the barrier ability against liquid and microorganisms and the testing methods, are usually lower than those of surgical gowns.