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ISO/TC 209 N 420, ISO/NP TS 14644-19 Cleanrooms and associated controlled environments -- Part 19: General technical requirements of modular isolation units for emergency medical use

Scope

This document specifies the terms and definitions, technical requirements, inspection and test, marking, packaging, transport and storage requirements of the emergency medical modular isolation units.

This document is applicable to the modular isolation units for emergency medical use.

Purpose

This proposal was proposed to solve the emergency isolation treatment to epidemic situation of infectious diseases and to curb the spread quickly, safely and efficiently, based on the mature anti epidemic isolation unit products.

Facing pandemic around the world, existing hospital or facility resources are completely out of reach of isolated treatment needs. There is an urgent need for a complete set of facilities with factory mass supply, isolation and treatment function integration, rapid placement and removal, and turnover cycle to meet the epidemic prevention needs. The emergency medical modular isolation unit described in this proposal is a type of facility.

In response to pandemic with a large number of patients, existing medical resources of each countries have been utilized at full capacity. Construction of new medical facilities and medical renovation of existing venues still cannot solve the problems:

(1) Medical resources such as the original hospital have better environmental conditions, but are far from meeting the needs of patients in pandemic;

(2) The new hospital can fully meet the corresponding medical isolation requirements, but the construction period is long, investment is large. After pandemic, the epidemic idle or demolition is wasteful

(3) Packaging box modular can save time, but the construction need a lot of manpower at site, which will increase the risk of cross-infection. At the time, this kind of modular is lack of comfort.

(4)Reconstruction the existing venues also can save time, but the original building system is not designed for medical use.

(5)Other types of temporary tents are low-cost and fast, but they are all of poor isolation and poor comfort.

So a resolution is needed to solve the request of bulk production and storage, commissioning quickly, do not need too much field work with the corresponding isolation function, comfort of the medical isolation unit.

Upon this proposal, at present, there are no relevant standards in the world, but modularization, medical isolation, negative pressure ventilation system and other independent technology have been relatively mature.

This proposal is integrated on the basis of their respective technology. Some of the technical parameters, test methods and general requirements of the existing standards are included in this proposal by reference. At present, the manufacture this type of product can be realize. Based on our China's mature experience and research work in the prevention and control of COVID 19, it can provide an effective solution to the spread of virus in the world. But there is no existing standard to regulate related product to provide an effective resolution for the world.

This document puts forward the technical requirements of unity and versatility of emergency medical isolation unit for epidemic prevention and auxiliary treatment of infectious diseases, and solves the problems of non-uniform standards, no standard basis, no replication and popularization in the production, sale and use of similar isolation unit products. V02/2019 It provides a rapid, safe and efficient way for end-users to isolate and assist in the treatment of infectious diseases.

It has characteristics of integrated production, mass storage, rapid deployment, safety isolation, recycling, which can effectively alleviate the shortage of medical and health organizations resources, meet emergency needs with safety and efficiency.

It also can effectively isolate infected patients or suspected cases for timely auxiliary treatment.

At the same time, effectively protect the staff and reduce the spread of infection of external public personnel.

Comment on proposal

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Please email further comments to: debbie.stead@bsigroup.com

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