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제목 [심규원 법제이사] New standard for 3D printing in healthcare
작성자 관리자 등록일 2023-09-07 조회수 149

 


New standard for 3D printing in healthcare
Anatomy in 3d
Image by Monoar Rahman Rony from Pixabay

Medical 3D printing is a fast growing and rapidly evolving sector, used in a wide range of areas from medical devices to surgery and personalized medicine. But few guidelines exist that can facilitate the sharing of data and processes that allow it to reach its potential even more. A new international standard has just been published to help.

Before the introduction of medical 3D printing, models needed to be made by hand in order to distinguish tissue parts. Not only was this time consuming and unhelpful in urgent situations, it made it tricky to use data from other medical staff.

Now the global market value of 3D printing in the healthcare sector is estimated to reach nearly US$20 billion in 2032. Widely used in developing medical devices such as in orthopedics, it enables personalized designs and faster, cheaper prototyping and production. It was also used to help manufacture personal protective equipment during the COVID-19 pandemic to help meet the increase in demand.

But that’s not all. By allowing the creation of patient-specific anatomical models, 3D printing has helped to improve outcomes in diagnosis and surgery, is used in education and there’s even talk it could one day fabricate human organs.

Professor Kyu Won Shim, acting convenor of the working group for 3D printing and scanning in the ISO/IEC Joint Technical Committee on ICT said the technology allows for very complex designs and is therefore not without its challenges.

“The right software is needed to be able to accurately and consistently visualize human anatomy, yet there are few guidelines and little guidance at an international level specifically for 3D printing technology,” he said.

“This standard provides standardized procedures and methods for medical 3D printing modeling software, which will be extremely helpful in domestic and overseas medical 3D printing software licensing.”

The newly published standard, ISO/IEC 3532-1 Medical image-based modelling for 3D printing - Part 1: General requirements aims to resolve that issue by specifying the requirements for medical image-based modelling for 3D printing for medical applications.

It covers aspects such as the process flow, and data processing requirements such as 3D reconstruction and visualization, calibration and validation of 3D and 3D conversion and file format.

Widespread use of the standard will help the technology to flourish, through recommending best practices and harmonizing language around the technology. 

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