교육영상 및 자료
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NOTICE
제 10차 혈류역학 WG 회의
제 10차 혈류역학 WG 회의 ▶ 일 시 : 2021년 12월 13일(월) 17:00 ~▶ 장 소 : 온라인 ZOOM▶ 참 석 자대요메디(주) 강희정 대표, 동국대학교 남기창 교수, 동국대학교 일산병원 이무용 교수, ㈜멕아이씨에스 이상학 이사▶ 안 건⑴ NP Form 작성본 리뷰 및 작성된 Draft의 수정사항 확인 및 검토⑵ NP 설명을 위한 발표자료 리뷰 진행▶ 사 진
2022.06.13
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NEWS
제 9차 혈류역학 WG 회의
제 9차 혈류역학 WG 회의 ▶ 일 시 : 2021년 11월 8일(월) 17:00 ~▶ 장 소 : 온라인 ZOOM▶ 참 석 자대요메디(주) 강희정 대표, 동국대학교 남기창 교수, 동국대학교 일산병원 이무용 교수, 서울대 안원식 교수, 한국표준과학연구원 도일 책임연구원, ㈜멕아이씨에스 이상학 이사▶ 안 건작성된 Draft의 Scope, 필수 인용 규격, 용어 및 정의 등 수정사항 확인 및 검토▶ 사 진
2022.06.13
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NEWS
제 8차 혈류역학 WG 회의
제 8차 혈류역학 WG 회의 ▶ 일 시 : 2021년 10월 6일(수) 17:00 ~▶ 장 소 : 온라인 ZOOM▶ 참 석 자대요메디(주) 강희정 대표, 동국대학교 남기창 교수, 동국대학교 일산병원 이무용 교수, 서울대 안원식 교수한국표준과학연구원 도일 책임연구원, ㈜멕아이씨에스 이상학 이사 ▶ 안 건Draft list 및 NP 작성 논의, 시험항목별 시험방법 지속 논의. 개발표준에 포함되어야하는 요구사항 논의. 논문 및 ALARM & SFC 리뷰▶ 사 진
2022.06.13
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NOTICE
ISO/TC 249 표준 제·개정 현황
ISO/TC 249 한의학 - 2022년 1월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 249 Traditional Chinese medicine DIS circulated ISO/DIS 5227 Traditional Chinese Medicine — Safety controls of cupping device - 2022년 2월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 249 Traditional Chinese medicine DIS circulated ISO/DIS 19609-4 Traditional Chinese medicine— Quality and safety of raw materials and finished products made with raw materials — Part 4: Testing for preservatives and unwanted compounds FDIS circulated ISO/FDIS 4154 Traditional Chinese medicine — Sinomenium acutum stem FDIS circulated ISO/FDIS 23958-1 Traditional Chinese medicine — Dermal needle for single use — Part 1: Tapping-type FDIS circulated ISO/FDIS 23958-2 Traditional Chinese medicine — Dermal needles for single use — Part 2: Roller-type FDIS circulated ISO/FDIS 24571 Traditional Chinese medicine — General requirements for the basic safety and essential performance of electro-acupuncture stimulators Standards published ISO 18665:2022 Traditional Chinese medicine — Herbal decoction apparatus Standards published ISO 23956:2022 Traditional Chinese medicine — Determination of benzopyrene in processed natural products - 2022년 3월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 249 Traditional Chinese medicine DIS circulated ISO/DIS 4564 Traditional Chinese Medicine — Scutellaria baicalensis root FDIS circulated ISO/TS 6304 Traditional Chinese medicine — Categorial structure for disorders FDIS circulated ISO/FDIS 23963-1 Traditional Chinese medicine — Requirements for process traceability systems in Chinese materia medica and decoction pieces — Part 1: Components FDIS circulated ISO/FDIS 24571 Traditional Chinese medicine — General requirements for the basic safety and essential performance of electro-acupuncture stimulators Standards published ISO 22585:2022 Traditional Chinese medicine — Co-donopsis pilosula root Standards published ISO 22586:2022 Traditional Chinese medicine — Paeonia lactiflora root — White peony root Standards published ISO 23965:2022 Traditional Chinese medicine — Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root - 2022년 4월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 249 Traditional Chinese medicine FDIS circulated ISO/FDIS 23963-2 Traditional Chinese medicine — Requirements for process trace ability system of Chinese materia medica and decoction pieces — Part 2: Electronic labelling - 2022년 5월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 249 Traditional Chinese medicine CD registered ISO/CD 6904 Traditional Chinese Medicine — General requirements for the ultrafine powder of herbs CD registered ISO/CD 8959 Traditional Chinese Medicine—Eucommia ulmoides stem bark CD registered ISO/CD 9109 Traditional Chinese medicine —Rehmannia glutinosa root CD registered ISO/CD 9306 Traditional Chinese Medicine — Ephedra sinica, Ephedra intermedia, and Ephedra equisetina herbaceous stem CD registered ISO/CD 9319 Traditional Chinese medicine —Poria cocos sclerotium FDIS circulated ISO/FDIS 23964 Traditional Chinese medicine — Saposhnikovia divaricata root and rhizome Standards published ISO 4154:2022 Traditional Chinese medicine — Sinomenium acutum stem Standards published ISO/TS 6304:2022 Traditional Chinese medicine — Categorial structure for disorders Standards published ISO 23958-1:2022 Traditional Chinese medicine — Dermal needles for single use — Part 1:Tappingtype Standards published ISO 23958-2:2022 Traditional Chinese medicine — Dermal needles for single use — Part 2:Roller-type
2022.07.18
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NEWS
ISO/TC 215 표준 제·개정 현황
ISO/TC 215 보건의료정보 - 2022년 1월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 215 Health informatics Standards published ISO 20302:2022 Health informatics — Health cards — Numbering system and registration procedure for issuer identifiers Standards published ISO 22077-1:2022 Health informatics — Medical waveform format — Part 1: Encoding rules Standards published ISO/TS 23535:2022 Health informatics — Requirements for customer-oriented health cloud service agreements - 2022년 2월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 215 Health informatics CD registered ISO/DTS 5569 Health Informatics — Conceptual Data Model for Chinese Medicinal Herbs CD registered ISO/DTS 17975.2 Health informatics — Principles and data requirements for consent in the Collection, Use or Disclosure of personal health information CD registered ISO/CD 22077-2 Health informatics — Medical waveform format — Part 2: Electrocardiography CD registered ISO/CD 22077-3 Health informatics — Medical waveform format — Part 3: Long term electrocardiography CD registered ISO/DTS 22218-1 Health informatics — Ophthalmic examination device data — Part 1: General Ophthalmic Examination Devices CD registered ISO/DTR 23358.2 Health informatics — A case study on establishing standardized measurement data in cardiac examination reports CD registered ISO/CD TR 24290.2 Healthcare Informatics — Datasets and format for clinical and biological evaluation metrics in radiotherapy Standards published ISO 13972:2022 Health informatics — Clinical information models — Characteristics, structures and requirements Standards withdrawn ISO/TS 13972:2015 (replaced by ISO 13972:2022) - 2022년 3월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 215 Health informatics CD registered ISO/CD 5477 Health Informatics —Interoperability of Public Health Emergency Preparedness and Re sponse Information Systems – Business Rules, Terminology and Data Vocabulary CD registered ISO/DTS 22218-2 Health Informatics — Ophthalmic examination device data — Part 2: Specular microscope Standards published ISO/IEEE 11073- 40101:2022 Health informatics — Device interoperability — Part 40101: Foundational — Cybersecurity — Processes for vulnerability assessment Standards published ISO/IEEE 11073- 40102:2022 Health informatics — Device interoperability — Part 40102: Foundational — Cybersecurity — Capabilities for mitigation Standards published ISO/TS 17117-2:2022 Health informatics — Terminological resources — Part 2: Implementation Capability (TIC) Standards published ISO 17439:2022 Health informatics — Development of terms and definitions for health informatics glossaries - 2022년 4월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 215 Health informatics CD registered ISO/DTS 4424 Genomics Informatics— Data Elements and their Metadata for Describing the Tumor Mutation Burden (TMB) Information of Clinical Massive Parallel DNA Sequencing FDIS circulated ISO/TS 5346 Health informatics — Catego rial structure for representation of traditional Chinese medicine clinical decision support system FDIS circulated ISO/PRF TS 16843-6 Health informatics — Categorial structures for representation of acupuncture — Part 6: Acupunc ture effects Standards published ISO 27269:2021 Health informatics — International patient summary - 2022년 5월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 215 Health informatics FDIS circulated ISO/TS 5118 Health informatics — Categorial structure of representation for evaluation of clinical practice guidelines of traditional Chinese medicine FDIS circulated ISO 11615:2017/ FDAmd 1 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information — Amendment 1 FDIS circulated ISO/PRF 4454 Genomics informatics — Phenopackets: A format for phenotypic data exchange
2022.07.18
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NEWS
ISO/TC 212 표준 제·개정 현황
ISO/TC 212 진단검사실검사 및 체외진단시스템 - 2022년 1월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 212 Clinical laboratory testing and in vitro diagnostic test systems FDIS circulated ISO 17593 Clinical laboratory testing and in vitro medical devices — Require - ments for in vitro monitoring systems for self-testing of oral anticoagulant therapy (Revision of ISO 17593:2007) FDIS circulated ISO/FDIS 21474-2 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification Standards published ISO 20776-2:2021 Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution Standards published ISO 22367:2020 Medical laboratories — Application of risk management to medical laboratories - 2022년 2월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 212 Clinical laboratory testing and in vitro diagnostic test systems FDIS circulated ISO/PRF TS 5798 In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods - 2022년 3월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 212 Clinical laboratory testing and in vitro diagnostic test systems Standards published ISO 17593:2022 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self testing of oral anticoagulant therapy - 2022년 4월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 212 Clinical laboratory testing and in vitro diagnostic test systems Standards published ISO/TS 5798:2022 In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) by nucleic acid amplification methods - 2022년 5월 표준 제 · 개정 진행 현황 TC Stage 표준 번호 표준 제목 TC 212 Clinical laboratory testing and in vitro diagnostic test systems Standards published ISO 21474-2:2022 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
2022.07.18