국제 표준화 활동현황(현재 진행중인 프로젝트)
ISO/TC249 진행현황 (2021.05 기준)
- PWI : Preliminary Work Item(예비작업항목)
- NP : New Work item Proposal(신규작업항목제안)
- AWI : Approved Work Item(승인작업항목)
- WD : Working Draft(작업초안)
- CD : Committee Draft(위원회안)
- DIS : Draft International Standard(질의안)
- FDIS : Final Draft International Standard(최종국제표준안)
- IS : International Standard(국제표준)
프로젝트별 구성현황 (2021.05 기준)
- WG1 : 한약재 및 전통공정의 품질 및 안전성
- WG2 : 한약제품의 품질 및 안전성
- WG3 : 침과 침의 안전한 사용에 대한 품질 및 안전성
- WG4 : 의료기기의 품질 및 안전성
- WG5 : 용어 및 의료정보
- JWG1 : 의료정보
ISO/TC249 국제표준 프로젝트 상세 진행현황
다운로드| WG | 제안표준명 | 현재상태 |
|---|---|---|
| 1 | Traditional Chinese medicine -- Ginseng seeds and seedlings -- Part 1: Panax ginseng CA Meyer (인삼 종자 및 종묘 - 1부 : 인삼) | IS |
| 1 | Traditional Chinese Medicine -- Determination of heavy metals in herbal medicines used in Traditional Chinese Medicine (한약재 중금속 측정) | IS |
| 1 | Traditional chinese medicine -- Schisandra chinensis (Turcz.) baill seeds and seedlings (오미자 종자 및 종묘) | IS |
| 1 | Salvia miltiorrhiza seeds and seedlings (단삼 종자 및 종묘) | IS |
| 1 | Panax notoginseng seeds and seedlings (삼칠삼 종자 및 종묘) | IS |
| 1 | Panax notoginseng root and rhizome (삼칠삼) | IS |
| 1 | Artemisiae Argyi Folium -- Artemisia argyi leaf (애엽) | IS |
| 1 | Traditional Chinese Medicine-Guidelines for Chinese materia medica specification (한약재 규격 지침) | IS |
| 1 | Microscopic examination on medicinal herbs (한약재 검경절차) | DTS |
| 1 | Astragalus Root(Astragalus membranaceus) (황기) | AWI |
| 1 | Platycodon grandiflorum Root (길경) | AWI |
| 1 | Traditional Chinese medicine-Salvia miltiorrhiza Root and Rhizome (단삼) | IS |
| 1 | Traditional Chinese Medicine-Ganoderma lucidum fruiting body (영지) | IS |
| 1 | Traditional Chinese Medicine-Isatis indigotica root (판람) | IS |
| 1 | Traditional Chinese Medicine-Lonicera japonica Flower (금은화) | IS |
| 1 | Traditional Chinese Medicine-Dendrobium Officinale Stem (철피석곡) | IS |
| 1 | Traditional Chinese Medicine-Gastrodia elata tuber (천마) | IS |
| 1 | Traditional Chinese Medicine -- Angelica sinensis root (당귀) | IS |
| 1 | Traditional Chinese Medicine -- Codonopisis pilosula root (만삼) | CD |
| 1 | Traditional Chinese Medicine-Paeonia lactiflora root (작약) | CD |
| 1 | Traditional Chinese Medicine -- Coix lacryma-jobi var. ma-yuen seed (율무) | 삭제 |
| 1 | Traditional Chinese Medicine -- Corydalis yanhusuo tuber (현호색) | 삭제 |
| 1 | Traditional Chinese Medicine -- Uncaria rhynchophylla stem with hook (조구등) | 삭제 |
| 1 | Traditional Chinese Medicine - Astragalus mongholicus root (몽골황기) | IS |
| 1 | Traditional Chinese Medicine -- Lycium barbarum and Lycium chinense fruit (구기자) | IS |
| 1 | Traditional Chinese Medicine-Crataegus fruit (산사) | PWI |
| 1 | Traditional Chinese Medicine -- Specification and grade of Saposhnikovia divaricata root(방풍) | 삭제 |
| 1 | Traditional Chinese Medicine -- Dimocarpus longan aril (용안육) | PWI |
| 1 | Traditional Chinese Medicine --General requirements for herbal raw material and materia medica(한약재 일반 요구사항) | FDIS |
| 1 | Traditional Chinese Medicine -- Glehnia littoralis root (해방풍) | DIS |
| 1 | Traditional Chinese Medicine -- Glycyrrhiza uralensis root and rhizome (감초) | PWI |
| 1 | Traditional Chinese Medicine -- Processed Aconitum carmichaelii lateral root (오두) | FDIS |
| 1 | Traditional Chinese Medicine -- Saposhnikovia divaricata root and rhizome (방풍) | AWI |
| 1 | Traditional Chinese Medicine -- Bupleurum chinense and Bupleurum scorzonrifolium root (시호) | WD |
| 1 | Traditional Chinese Medicine -- Panax quinquefolium root (서양삼) | PWI |
| 1 | Traditional Chinese Medicine -- Gravimetric determination of total ginseng saponins (인삼 사포닌 중량 측정) | PWI |
| 1 | Traditional Chinese Medicine -- Zingiber officinale rhizome (건강) | DIS |
| 1 | Traditional chinese Medicine -- Priority list for developing standards for single herbal medicines in ISO/TC249 (ISO/TC249 개별한약재 표준개발 우선순위 목록) | TR |
| 1 | Traditional Chinese Medicine -- Andrographis paniculata herb (천심련) | PWI |
| 1 | Traditional Chinese Medicine --Sinomenium acutum stem (방기) | CD |
| 1 | Traditional Chinese Medicine--Scutellaria baicalensis Georgi root (황금) | CD |
| 1 | Traditional Chinese Medicine -- Coptis chinensis and Coptis japonica rhizome (황련) | NP |
| 1 | Traditional Chinese Medicine --Pinellia ternata tuber (반하) | NP |
| 1 | Traditional Chinese Medicine -- Rheum palmatum, Rheum tanguticum, and Rheum officinale root and rhizome (대황(장엽대황, 탕구트대황 및 약용대황)) | NP |
| 1 | Traditional Chinese medicine — Schisandra chinensis fruit (오미자) | NP |
| 1 | Traditional Chinese Medicine — Ligusticum chuanxiong rhizome (중국천궁) | NP |
| 2 | Traditional Chinese medicine -- Quality and safety of natural materials and manufacturing products made with natural materials used in and as traditional Chinese medicine (TCM) -- Part 1: General(한약재 및 한약제제의 품질 및 안전성-1부:일반) | IS |
| 2 | Traditional Chinese medicine -- Quality and safety of natural materials and manufacturing products made with natural materials used in and as traditional Chinese medicine (TCM) -- Part 2: Identity testing (한약재 및 한약제제의 품질 및 안전성-2부:감별 시험) | IS |
| 2 | Traditional Chinese medicine -- Quality and safety of natural materials and manufacturing products made with natural materials used in and as traditional Chinese medicine (TCM) -- Part 3: Testing for the absence of contaminants (한약재 및 한약제제의 품질 및 안전성-3부 : 오염물질 부재 시험 ) | WD |
| 2 | Traditional Chinese medicine -- Quality and safety of natural materials and manufacturing products made with natural materials used in and as traditional Chinese medicine (TCM) -- Part 4: Testing for preservatives and non-wanted compounds (한약재 및 한약제제의 품질 및 안전성-4부 : 방부제 및 비 화합물 시험) | WD |
| 2 | Traditional Chinese Medicine-General requirements for industrial manufacturing process of red ginseng (Panax ginseng C.A. Meyer) (홍삼 제조공정 요구사항) | IS |
| 2 | Traditional Chinese medicine -- General requirements for the manufacturing process of natural products (한약재 제조공정 일반요구사항) | IS |
| 2 | Traditional Chinese medicine -- Labelling requirements of products intended for oral or topical use (식의약품 라벨링 요구사항) | IS |
| 2 | Traditional Chinese medicine -- Minimum requirements for herbal preparations services(한약조제 최소 요구사항) | CD |
| 2 | Storage requirements for Chinese materia medica and decoction pieces (한약재 보관 요구사항) | IS |
| 2 | Determination of irradiated Traditional Chinese Medicine using photostimulated luminescence (PSL을 사용한 한약재 방사선 검출) | IS |
| 2 | Determination of pesticide residues in herbal medicines used in Traditional Chinese Medicine (한약재 잔류농약 측정) | IS |
| 2 | Determination of Aflatoxins in Herbal Medicines Used in Traditional Chinese Medicines -- Method by LC-FLD (한약재 아플라톡신 측정 – LC-FLD 방법 ) | IS |
| 2 | Traditional Chinese Medicine- Determination of microorganism in herbal medicines used in Traditional Chinese Medicine (한약재 미생물 측정) | DIS |
| 2 | Traditional Chinese medicine- Determination of Sulfur Dioxide in herbal medicines used in Traditional Chinese Medicine (한약재 이산화황 측정) | IS |
| 2 | Traditional Chinese medicine-Determination of Ochratoxin A in Herbal Medicines Used in Traditional Chinese Medicine -- Method by LC-FLD (한약재 오크라톡신 측정 - LC-FLD 방법) | PWI |
| 2 | Traditional Chinese medicine-Determination of Aristolochic Acids in Manufactured Products from Traditional Chinese Medicine (한약재 아리스토로크산 측정) | FDIS |
| 2 | Traditional Chinese Medicine --Determination of selected Aconitum alkaloids-Method using high-performance liquid chromatography (HPLC) (한약재 아코니트알칼로이드 측정 - HPLC 방법) | IS |
| 2 | Traditional Chinese Medicine -- General Requirement of Manufacturing Procedure and its Quality Control for Granules (과립제 품질관리 및 생산절차 요구사항) | DIS |
| 2 | Traditional Chinese Medicine -- Determination of benzopyrene in processed natural products (한약재 벤조피렌 측정) | DIS |
| 2 | Traditional Chinese Medicine — Fermented Cordyceps Powder (동충하초 균분) | CD |
| 2 | Traditional Chinese Medicine — inner pack of decoction pieces (음편 내부 포장) | WD |
| 2 | Traditional Chinese Medicine — General requirements for the ultrafine powder of herbs (한약재 미세분말 일반 요구사항) | WD |
| 3 | Sterile acupuncture needles for single use (일회용멸균호침) | IS |
| 3 | Traditional Chinese medicine - Sterile intradermal acupuncture needles for single use (일회용 멸균 피내침) | IS |
| 3 | Test method of single-use acupuncture needle for electrical stimulation (전침용침 시험방법) | IS |
| 3 | Traditional Chinese medicine -- Infection control for acupuncture treatment (침시술 감염관리) | TR |
| 3 | Thread Embedding Acupuncture Needle for single use (일회용 매선침) | IS |
| 3 | TCM- Dermal Needle for single use -- Part 1: Tapping type (일회용 피부침 - 1부: 탭핑 타입) | DIS |
| 3 | TCM- Dermal Needle for single use -- Part 2: Roller Type (일회용 피부침 - 2부: 롤러 타입) | DIS |
| 3 | Traditional Chinese Medicine -- Single-use sterile acupotomy needle | PWI |
| 3 | Traditional Chinese Medicine -- Sterile Three-Edge Needle for Single Use(삼릉침) | WD |
| 4 | Traditional Chinese medicine -- General requirements of electric radial pulse tonometric device (맥진기 일반요구사항) | IS |
| 4 | Herbal decoction apparatus (한약추출기) | IS |
| 4 | Traditional Chinese medicine -- General requirements of Moxibustion devices (뜸 일반요구사항) | IS |
| 4 | Traditional Chinese Medicine - Air extraction cupping device (공기배출형 부항컵) | IS |
| 4 | Traditional Chinese Medicine-Pulse Graph Force Transducer (맥파변환기) | IS |
| 4 | Traditional Chinese Medicine - Gua Sha instruments (괄사) | IS |
| 4 | Infrared moxibustion–like instruments (적외선 뜸 장치) | IS |
| 4 | Traditional Chinese medicine -- Skin electrical resistance measurement devices (피부저항측정기) | IS |
| 4 | Traditional Chinese medicine -- Abdominal physiological parameter detector (복부 생리학적 변수 탐지기) | TS |
| 4 | Computerized tongue image analysis system Part1 : General requirements (설진기 - 1부 : 일반요구사항) | IS |
| 4 | Computerised tongue image analysis system Part2 : Light environment (설진기 - 2부 : 조명환경) | IS |
| 4 | Traditional Chinese medicine -- Computerized tongue image analysis system -- Part 3: Colour chart (설진기 - 3부 : 색상차트) | DTS |
| 4 | Traditional Chinese medicine -- Computerized tongue image analysis system -- Part 4: Peripheral visual instruments (설진기 - 4부 : 시각기기) | TS |
| 4 | Computerized tongue image analysis system -- Part 5: Method of acquisition and expression of tongue colour and tongue coating colour (설진기 – 5부 : 설색 및 설태 색상) | TR |
| 4 | Traditional Chinese medicine --Therapeutic Fumigation Devices (치료용 훈증기) | IS |
| 4 | Electric Heating Moxibustion Equipment (전기식 온구기) | IS |
| 4 | General requirements for smokeless moxibustion devices (무연뜸의 일반요구사항) | IS |
| 4 | Glass cupping device (전통 유리 부항) | IS |
| 4 | Laser Acupoint Radiation Device(경혈 레이저 조사기) | FDIS |
| 4 | Traditional Chinese Medicine-Acupoint Magnetotherapy Plaster (자기패치) | WD |
| 4 | General requirements for the basic safety and essential performance of electro-acupuncture stimulator(전침기의 안전 및 필수성능 요구사항) | DIS |
| 4 | Traditional Chinese Medicine — Safety controls of cupping device (부항 안전 관리) | WD |
| 4 | Traditional Chinese Medicine — Method of sample preparation for smoke density test of smokeless moxibustion device (무연뜸 연기밀도 시험을 위한 샘플 준비 방법) | NP TS |
| 4 | Traditional Chinese Medicine — Test method for moxa floss quality — concentration of waste particles (애융품질 시험 방법 - 잡질량 농도) | WD TS |
| 5 | Traditional Chinese medicine -- Vocabulary -- Part 1: Chinese Materia Medica (한의약-용어-1부:한약재) | IS |
| 5 | Traditional Chinese medicine -Vocabulary-Part 2: Processing of Chinese Materia Medica (한의약 용어-2부: 한약재 포제 ) | IS |
| 5 | Traditional Chinese Medicine —Categories of traditional Chinese medicine (TCM) clinical terminological systems (한의약 임상용어구조) | IS |
| 5 | Traditional Chinese Medicines -- Coding system of formulae (방제 코딩시스템) | IS |
| 5 | Traditional Chinese medicine -- Controlled vocabulary on Japanese Kampo crude drugs(KAMPO 관리 약재 용어) | TR |
| 5 | Traditional Chinese medicine -- Controlled vocabulary on Japanese Kampo formulas and the indication codes for the products(KAMPO 관리 방제 및 코드 용어) | TR |
| 5 | Traditional Chinese Medicine -- Vocabulary for Diagnostics -- Part 1: Tongue (진단용어 - 1부: 설진) | DIS |
| 5 | Traditional Chinese Medicine -- Vocabulary for Diagnostics -- Part 2: Pulse (진단용어 - 2부: 맥진) | DIS |
| 5 | Traditional Chinese Medicine — Vocabulary for Diagnostics — Part 3: Abdomen (복진용어) | WD |
| JWG1 | Coding system of Chinese medicines -- Part 1: Coding rules for Chinese medicines (한약재 코딩시스템 – 1부: 한약 코딩 규칙) | IS |
| JWG1 | Coding system of Chinese medicines -- Part 2: Codes of decoction pieces (한약재 코딩시스템 – 2부: 규격품 음편 코드) | IS |
| JWG1 | Traditional Chinese medicine -- Coding rules for Chinese medicines in supply chain management (한약 공급망 코딩 규칙 ) | IS |
| JWG1 | Coding system of Chinese Medicines – Part 3: Codes of Chinese Materia Medica (한약재 코딩 시스템 – 3부 : 본초 코드 ) | IS |
| JWG1 | Coding System of Chinese Medicines – Part 4: Codes of Granule forms of individual medicinal for prescriptions (GFIMP) (한약재 코딩 시스템 – 4부 : 단미 (배방) 과립제 코드) | IS |
| JWG1 | Traditional Chinese Medical -- Pulse Waveform format (맥파 파형 포맷) | IS |
| JWG1 | Traditional Chinese Medicine--Categories of Integration of Traditional Chinese Medicine and Western Medicine-- Clinical Terminological System (통합의학 (한의약 -현대의학) 구조 – 임상용어 시스템) | TS |
| JWG1 | Traditional Chinese Medicine- Clinical Document Architecture (CDA) for Prescription of TCM Decoction Pieces (한약재 음편처방 임상문서구조) | TS |
| JWG1 | Traditional Chinese Medicine -- requirements for process traceability system of Chinese materia medica and decoction pieces -- Part 1: components (한약재 및 음편 공정 추적 시스템 요구사항 - 1부: 구성요소) | AWI |
| JWG1 | Traditional Chinese Medicine -- requirements for process traceability system of Chinese materia medica and decoction pieces -- Part 2: electronic labelling (한약재 및 음편 공정 추적 시스템 요구사항 - 2부: 전자 라벨링) | AWI |
| JWG1 | Traditional Chinese Medicine -- Coding System for Chinese Patent Medicines -- Part 1: Coding Rules (중성약 코딩 시스템 - 1부: 코딩 규칙) | PWI |
| JWG1 | Traditional Chinese medicine — Categorial structure for classification of disease — Part 1: Disorders (질병분류구조 - 1부: 병증) | WD TS |
국내 표준화 활동현황
2009년 일회용 멸균호침에 대한 KS 제정 이후 현재까지 총 9건의 한의학 관련 KS가 제정됨
| KS번호 | 표준명 | 내용 | 제정일 |
|---|---|---|---|
| KS P ISO 17218 | 일회용멸균 호침 | 한의학 의료용으로 사용하는 스테인리스 강선으로 제작된 일회용 멸균호침의 치수, 재료, 품질, 시험, 포장 및 표기 방법에 대하여 규정 | 2009.08.20(제정) 2016.12.20(개정) |
| KS P 3008 | 이침 | 한의학 의료용으로 사용하는 스테인리스 강재로 제작된 이침의 치수, 재료, 품질, 시험, 포장 및 표기 방법에 대하여 규정 | 2010.12.30(제정) 2015.07.31(확인) |
| KS P 3009 | 피내침 | 한의학 의료용으로 사용하는 스테인리스 강재로 제작된 피내침의 치수, 재료, 품질, 시험, 포장 및 표기 방법에 대하여 규정 | 2010.12.30(제정) 2015.07.31(확인) |
| KS P 2000 | 한의약 - 침시술안전관리 | 침시술 시 발생할 수 있는 감염 및 이상반응 등의 위험으로부터 환자, 의료인 및 보조 인력의 건강을 보호하기 위한 침시술 안전관리에 대하여 규정 | 2012.01.02(제정) 2017.12.29(확인) |
| KS P 3010 | 한의약 - 인체 경혈 명칭 및 위치- 14경맥 | 14경맥의 명칭과 361개 경혈의 명칭, 위치 및 체표 표면의 경혈을 찾는 방법에 적용 | 2012.01.02(제정) 2017.12.29(확인) |
| KS P 1927 | 한의약 - 한약 추출기 | 설계압력이 0.1 MPa 미만인 압력식 및 무압력식 한약 추출기의 일반 요건에 대하여 규정 | 2017.09.29(제정) |
| KS P 3000 | 한의약 - 뜸 - 일반 요구 사항 |
의료용으로 사용하는 뜸의 종류, 뜸을 뜨는데 사용되는 재료 및 뜸을 뜨는데 사용되는 재료의 시험방법과 포장 및 표기 방법에 대하여 규정 | 2012.01.02(제정) 2017.09.29(폐지) |
| KS P 1928 | 한의약 - 뜸기구의 일반 요구사항 |
뜸기구의 구성, 재질, 성능 및 안전성에 대한 일반 요구사항을 규정 | 2017.09.29(제정) |
| KS P ISO 19610 | 한의약 - 홍삼 제조공정 일반 요구사항 |
Panax ginseng C.A. Meyer로만 제조할 수 있는 홍삼의 산업적 제조 공정에 대한 일반적 요구사항을 규정 | 2018.08.22(제정) |
| KS P ISO 19611 | 한의약 - 공기 배출형 부항기 |
음압을 사용하여 작동하는 공기 배출형 부항기에 대한 요건을 규정 | 2018.08.22(제정) |