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Government Legislation

  • [Other] Administrative Notice of Partial Revision (Draft) to the Standard Specifications of Medical Devices
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2024-10-24
    • Opinion Submission Deadline : 2024-12-23

1. Reason for Revision

In consideration of the safety of users of radiation protection aprons, the revision clarifies the test standards and methods to be applied only when “Lead free” is expressed or written regarding lead content.


2. Main Contents

a. Revision of the standard specifications for “aprons for radiation protection” (Attached Table 3-10 of the draft)

1) The revision clarifies the definition of the term 'lead-free apron' and presents test standards such as the total amount of lead defined as 'lead content' under the test standard

2) The revision presents the test methods, such as those to be used for lead content testing, sample collection sites, and methods of measuring lead content, which are to be applied when “Lead free” is expressed or written.

3) In the case of lead-free aprons, the revision clarifies the labeling requirements to ensure proper management when "Lead-free" or "No lead used" is expressed.

Regulatory effect assessment
  • 의료기기 기준규격(규제영향분석서)_20241024.hwp [download]
Legislative proposal (draft)
  • 「의료기기 기준규격」 방사선방어용앞치마 일부개정고시안.hwpx [download]