⊙식품의약품안전처공고제2021-612호
의료제품 분야 산업표준(KS)을 제정함에 있어 국민, 업계 및 관련기관에 미리 알려 의견을 듣고자 그 제정 사유와 주요 내용을 산업표준화법 제5조제1항 및 같은 법 시행령 제16조에 의하여 다음과 같이 공고합니다.
2021년 12월 27일
식품의약품안전처장
의료제품 분야 산업표준(KS) 제정 행정예고
1. 표준번호 및 표준명
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)
* 표준내용은 e-나라표준인증(http://www.standard.go.kr)에서 확인 가능
2. 제정사유
신설된 국제표준(ISO)의 국내 도입 및 연구개발 결과물을 반영한 의료제품분야 산업표준을 제정하고자 함
3. 주요내용
가. 국제표준 도입
○ ‘비활성 외과용 이식재 ― 이식재 코팅 ― 제2부: 코팅과 관련된 참조표준’과 관련한 국제표준* 등 ISO/TC 150(외과용이식재)에서 발간한 2종을 산업표준으로 제정
* ISO/TR 17327-2:2021 Non-active surgical implants — Implant coating — Part 2: Reference standards related to coatings
4. 의견제출
의료제품 분야 산업표준(KS) 제정(안)에 대하여 의견이 있는 단체, 업체 또는 개인은 2022년 3월 1일까지 다음 사항을 기재한 의견서를 식품의약품안전처장에게 제출하여 주시기 바랍니다.
가. 예고사항에 대한 의견(찬·반 여부와 그 사유 등)
나. 성명(단체인 경우 단체명과 그 대표자 성명), 주소 및 전화번호
다. 기타 참고사항
<제출방법>
가. 우편: (우편번호 : 28159) 충청북도 청주시 흥덕구 오송읍 오송생명2로 187, 식품의약품안전처 의료기기 기준·정보화팀
나. 전자우편: sky2410@korea.kr
다. 팩스: 043-719-5650 (☏ 043-719-5653, 5660)