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표준화활동현황

국제 표준화 활동현황(현재 진행중인 프로젝트)

ISO/TC249 진행현황 (2024 .02 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 (2024 .02 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
국제 표준화 활동현황(현재 진행중인 프로젝트)
WG 제안표준명 현재상태
1Traditional Chinese medicine — Ginseng seeds and seedlings — Part 1: Panax ginseng C.A. MeyerIS
1Traditional Chinese Medicine -- Determination of heavy metals in herbal medicines used in Traditional Chinese MedicineIS
1Traditional Chinese Medicine -- Schisandra chinensis (Turcz.) Baill. seeds and seedlings.IS
1Traditional Chinese Medicine -- Salvia miltiorrhiza seeds and seedlingsIS
1Traditional Chinese Medicine -- Panax notoginseng seeds and seedlingsIS
1Traditional Chinese Medicine -- Panax notoginseng root and rhizomeIS
1Traditional Chinese Medicine -- Artemisiae Argyi Folium -- Artemisia argyi leafIS
1Traditional Chinese Medicine -- Guidelines and specification for Chinese materia medicaIS
1Traditional Chinese Medicine -- Microscopic examination on medicinal herbsTS
1traditional Chinese medicine — Astragalus root (astragalus membranaceus)삭제
1traditional Chinese medicine — Platycodon grandiflorum root삭제
1Traditional Chinese Medicine -- Salvia miltiorrhiza Root and RhizomeIS
1Traditional Chinese Medicine -- Ganoderma lucidum fruiting bodyIS
1Traditional Chinese Medicine -- Isatis indigotica rootIS
1Traditional Chinese Medicine -- Lonicera japonica FlowerIS
1Traditional Chinese Medicine -- Dendrobium Officinale StemIS
1Traditional Chinese Medicine -- Gastrodia elata tuberIS
1Traditional Chinese Medicine -- Angelica sinensis rootIS
1Traditional Chinese Medicine -- Codonopisis pilosula rootIS
1Traditional Chinese Medicine -- Paeonia lactiflora rootIS
1Traditional Chinese Medicine -- Coix lacryma-jobi var. ma-yuen seed삭제
1Traditional Chinese Medicine -- Corydalis yanhusuo tuber삭제
1Traditional Chinese Medicine -- Uncaria rhynchophylla stem with hook삭제
1Traditional Chinese Medicine -- Astragalus mongholicus rootIS
1Traditional Chinese Medicine -- Crataegus fruit삭제
1Traditional Chinese Medicine -- Lycium barbarum and Lycium chinense fruitIS
1Traditional Chinese Medicine -- Specification and grade of Saposhnikovia divaricata root삭제
1Traditional Chinese Medicine -- Dimocarpus longan aril삭제
1Traditional Chinese Medicine -- General requirements for herbal raw material and materia medicaIS
1Traditional Chinese Medicine -- Glehnia littoralis rootIS
1Traditional Chinese Medicine -- Glycyrrhiza uralensis root and rhizome삭제
1Traditional Chinese Medicine -- Processed Aconitum carmichaelii lateral rootIS
1Traditional Chinese Medicine -- Saposhnikovia divaricata root and rhizomeIS
1Traditional Chinese Medicine -- Bupleurum chinense and Bupleurum scorzonrifolium rootIS
1Traditional Chinese Medicine -- Panax quinquefolium root삭제
1Traditional Chinese Medicine -- Gravimetric determination of total ginseng saponins삭제
1Traditional Chinese Medicine -- Zingiber officinale rhizomeIS
1Traditional chinese Medicine -- Priority list for developing standards for single herbal medicines in ISO/TC249TR
1Traditional Chinese Medicine -- Andrographis paniculata herb삭제
1Traditional Chinese Medicine --Sinomenium acutum stemIS
1Traditional Chinese Medicine--Scutellaria baicalensis Georgi rootIS
1Traditional Chinese Medicine -- Coptis chinensis and Coptis japonica rhizomeIS
1Traditional Chinese Medicine --Pinellia ternata tuberIS
1Traditional Chinese Medicine --Rheum palmatum, Rheum tanguticum, and Rheum officinale root and rhizomeIS
1Traditional Chinese medicine — Schisandra chinensis fruitPWI
1Traditional Chinese Medicine — Ligusticum chuanxiong rhizomeFDIS
1Traditional Chinese Medicine--Eucommia ulmoides stem barkDIS
1Traditional Chinese Medicine--Areca catechu seedNP
1Traditional Chinese medicine --Rehmannia glutinosa rootIS
1Traditional Chinese Medicine — Curcuma Longa rhizomeDIS
1Traditional Chinese Medicine — Ephedra sinica, Ephedra intermedia, and Ephedra equisetina herbaceous stemIS
1Traditional Chinese medicine --Poria cocos sclerotiumFDIS
1Traditional Chinese Medicine----Polygala tenuifolia and Polygala sibirica rootCD
1Traditional Chinese Medicine --Angelica dahurica rootFDIS
1Traditional Chinese Medicine --Gardenia jasminoides fruitFDIS
1Traditional Chinese Medicine- Atractylodes macrocephala rhizomeDIS
1Traditional Chinese Medicine --Polygonum multiflorum rootCD
1Traditional Chinese Medicine — Glycyrrhiza uralensis, Glycyrrhiza inflata, and Glycyrrhiza glabra roots and rhizomeDIS
1Traditional Chinese Medicine — Glycyrrhiza uralensis and Glycyrrhiza glabra seeds and seedlingsCD
1Traditional Chinese Medicine--Platycodon grandiflorus rootDIS
1Traditional Chinese Medicine --Dioscorea opposita rhizomeDIS
1Traditional Chinese Medicine --Cinnamomum cassia branchDIS
1Traditional Chinese Medicine--Anemarrhena asphodeloides rhizomeNP
1Traditional Chinese Medicine--Carthamus tinctorius flowerDIS
1Traditional Chinese medicine----Epimedium brevicorum, Epimedium sagittatum, Epimedium pubescens, and Epimedium koreanum HerbPWI
1Traditional Chinese medicine--Report on Panax ginseng in terms of industry and standardization developmentTR
1Traditional Chinese Medicine --Crocus sativus stigmaWD
1Traditional Chinese medicine--Euodia (syn. Evodia or Tetradium) fruitWD
1Traditional Chinese medicine — Ziziphus jujuba fruitWD
1Traditional Chinese medicine--General requirements for the cultivation and primary processing of herbal materialsNP
1Traditional Chinese medicine -- Sophora tonkinensis root and rhizomeNP
1Traditional Chinese medicine — Aconitum carmichaelii parent root tuberWD
1Traditional Chinese medicine -- Zanthoxylum nitidum rootNP
1Traditional Chinese Medicine — Pueraria lobata rootNP
1Traditional Chinese medicine-Gentiana scabra, Gentiana manshurica, and Gentiana triflora roots and rhizomeNP
1Traditional Chinese medicine — cultivated Cistanche deserticola stemNP
1Traditional Chinese Medicine-Curcuma phaeocaulis, Curcuma kwangsiensis, and Curcuma wenyujin rhizomeNP
2Traditional Chinese Medicine -- Quality and safety of natural materials and manufacturing products made with natural materials -- Part 1: General requirementsIS
2Traditional Chinese Medicine -- Quality and safety of natural materials and manufacturing products made with natural materials -- Part 2: Identity testing of constituents of herbal originIS
2Traditional 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 contaminantsIS
2Traditional 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 compoundsIS
2Traditional Chinese Medicine -- General requirements for industrial manufacturing process of red ginseng (Panax ginseng C.A. Meyer)IS
2Traditional Chinese Medicine -- General requirements for the manufacturing process of natural productsIS
2Traditional Chinese Medicine -- Labelling requirements of products intended for oral or topical useIS
2Traditional Chinese Medicine -- Storage requirements for raw materials and decoction piecesIS
2Traditional Chinese Medicine -- Detection of irradiated natural products by photostimulated luminescenceIS
2Traditional Chinese Medicine -- Determination of pesticide residues in natural products by GCIS
2Traditional Chinese Medicine -- Determination of Aflatoxins in natural products by LC-FLDIS
2Traditional Chinese Medicine -- Determination of microorganism in natural productsIS
2Traditional Chinese Medicine -- Determination of Sulfur Dioxide in natural products by titrationIS
2Traditional Chinese Medicine -- Determination of Ochratoxin A in natural products by LC-FLD삭제
2Traditional Chinese Medicine -- Determination of aristolochic acids in natural products by HPLCIS
2Traditional Chinese Medicine -- Determination of selected Aconitum alkaloids by HPLCIS
2Traditional Chinese Medicine -- General requirement of manufacturing procedure and its quality control for granulesIS
2Traditional Chinese Medicine -- Determination of benzopyrene in processed natural productsIS
2Traditional Chinese Medicine — Fermented Cordyceps PowderIS
2Traditional Chinese Medicine — inner pack of decoction piecesIS
2Traditional Chinese Medicine — General requirements for the ultrafine powder of herbsFDIS
2Traditional Chinese Medicine – Simplified accelerated stress simulation methodsDIS
2Traditional Chinese medicine — Chemical profiling methods of herbal medicines using chromatographic fingerprintingPWI TS
2Traditional Chinese medicine — Determination of Ochratoxin A in natural product by LC-FLDTS
2Traditional Chinese medicine — Minimum requirements for herbal dispensing servicesCD
2Traditional Chinese medicine — General requirements of manufacturing procedures and quality for Salvia miltiorrhiza formula granulesWD TS
2Traditional Chinese Medicine — General requirements of stick-type package for viscous extractsWD TS
2Traditional Chinese medicine — General principles for the establishment of herbal reference substancesWD
2Traditional Chinese medicine --Astragalus mongholicus root aqueous extract granulesNP
2Angelica sinensis root aqueous extract granulesNP
2Traditional Chinese medicine — Sporoderm-broken Ganoderma lucidum spore powderNP
3Sterile acupuncture needles for single useIS
3Traditional Chinese Medicine -- Sterile intradermal acupuncture needles for single useIS
3Traditional Chinese Medicine -- Test method of single-use acupuncture needle for electrical stimulationIS
3Traditional Chinese Medicine -- Infection control for acupuncture treatmentTR
3Traditional Chinese Medicine -- Thread Embedding Acupuncture Needle for single useTS
3Traditional Chinese medicine — Dermal Needle for single use -- Part 1: Tapping typeIS
3Traditional Chinese medicine — Dermal Needle for single use -- Part 2: Roller TypeIS
3Traditional Chinese Medicine -- Single-use sterile acupotomy needle삭제
3Traditional Chinese medicine — Sterile acupotomy needle for single useNP
3Traditional Chinese Medicine -- Sterile Three-Edge Needle for Single UseDIS
4Traditional Chinese Medicine -- Herbal decoction apparatusIS
4Traditional Chinese Medicine -- General requirements of Moxibustion devicesIS
4Traditional Chinese Medicine -- Computerised tongue image analysis system -- Part2 : Light environmentIS
4Traditional Chinese Medicine -- Gua Sha instrumentsIS
4Traditional Chinese Medicine -- Air extraction cupping deviceIS
4Traditional Chinese Medicine -- Pulse Graph Force TransducerIS
4Traditional Chinese Medicine -- Skin electrical resistance measurement devicesIS
4Traditional Chinese Medicine -- Infrared moxibustion-like instrumentIS
4Traditional Chinese Medicine -- Computerized tongue image analysis system -- Part 5: Method of acquisition and expression of tongue colour and tongue coating colourTR
4Traditional Chinese Medicine -- Abdominal physiological parameter detectorTS
4Traditional Chinese Medicine -- Computerized tongue image analysis system -- Part 1: General requirementsIS
4Traditional Chinese Medicine -- General requirements for smokeless moxibustion devicesIS
4Traditional Chinese Medicine -- Therapeutic Fumigation DevicesIS
4Traditional Chinese Medicine -- General requirements of electric radial pulse tonometric deviceIS
4Traditional Chinese Medicine -- Computerized tongue image analysis system -- Part 3: Colour chartTS
4Traditional Chinese medicine — Electric heating moxibustion equipmentIS
4Traditional Chinese Medicine -- Glass cupping deviceIS
4Traditional Chinese Medicine -- Computerized tongue image analysis system -- Part 4: Peripheral visual instrumentsTS
4General requirements for the basic safety and essential performance of electro-acupuncture stimulatorIS
4Traditional Chinese Medicine -- Laser Acupoint Radiation DeviceIS
4Traditional Chinese Medicine -- Acupoint magnetotherapy plaster for single useIS
4Traditional Chinese Medicine -- Electrical Cupping Device삭제
4Traditional Chinese Medicine — Safety controls of cupping deviceIS
4Traditional Chinese Medicine — Method of sample preparation for smoke density test of smokeless moxibustion devicePWI TS
4Traditional Chinese Medicine — Test method for moxa floss quality — concentration of waste particlesCD TS
4Traditional Chinese Medicine-- General requirements for the basic safety and essential performance of the transcutaneous electrical acupoint stimulatorsNP
5Traditional Chinese Medicine -- Vocabulary -- Part 1: Chinese Materia MedicaIS
5Traditional Chinese Medicine -- Categories of traditional Chinese medicine (TCM) clinical terminological systemsIS
5Traditional Chinese Medicine -- Coding system of formulaeIS
5Traditional Chinese Medicine -- Vocabulary -- Part 2: Processing of Chinese Materia MedicaIS
5Traditional Chinese Medicine -- Controlled vocabulary on Japanese Kampo crude drugsTR
5Traditional Chinese Medicine -- Controlled vocabulary on Japanese Kampo formulas and the indication codes for the productsTR
5Traditional Chinese Medicine -- Vocabulary for Diagnostics -- Part 1: TongueIS
5Traditional Chinese Medicine -- Vocabulary for Diagnostics -- Part 2: PulseIS
5Traditional Chinese Medicine — Vocabulary for Diagnostics — Part 3: AbdomenCD TS
5Traditional Chinese medicine — Guide to the language usage in terminology workPWI TS
5Traditional Chinese medicine -- Vocabulary -- Part 3: Efficacy of Chinese Materia MedicaCD
JWG1Traditional Chinese Medicine -- Coding system for Chinese medicines -- Part 1: Coding rules for Chinese medicinesIS
JWG1Traditional Chinese Medicine -- Coding system for Chinese medicines -- Part 2: Codes for decoction piecesIS
JWG1Traditional Chinese Medicine -- Coding rules for Chinese medicines in supply chain managementIS
JWG1Traditional Chinese Medicine -- Coding system for Chinese medicines – Part 3: Codes for Chinese Materia MedicaIS
JWG1Traditional Chinese medicine — Coding system for Chinese medicines — Part 4: Codes for granule forms of individual medicinals for prescriptionsIS
JWG1Traditional Chinese Medicine -- Pulse Waveform formatIS
JWG1Traditional Chinese Medicine -- Categories of clinical terminological system to support the integration of clinical terms from Traditional Chinese medicine and western medicineTS
JWG1Traditional Chinese Medicine -- Clinical Document specification for prescription of TCM decoction piecesTS
JWG1Traditional Chinese Medicine -- requirements for process traceability system of Chinese materia medica and decoction pieces -- Part 1: componentsIS
JWG1Traditional Chinese Medicine -- requirements for process traceability system of Chinese materia medica and decoction pieces -- Part 2: electronic labellingIS
JWG1Traditional Chinese Medicine -- Coding System for Chinese Patent Medicines -- Part 1: Coding Rules삭제
JWG1Traditional Chinese medicine — Categorial structure for disorderTS
JWG1Traditional Chinese medicine -- Information model for dispensary preparation of decocted herbal medicinesPWI TS
JWG1Traditional Chinese medicine — Categorial structure for patternsPWI TS
JWG1Traditional Chinese medicine — Clinical knowledge structure for diagnostic information — Part 1: TongueNP TS
JWG1Traditional Chinese medicine — Clinical knowledge structure for diagnostic information — Part 2: PulseWD TS

국내 표준화 활동현황

2009년 일회용 멸균호침에 대한 KS 제정 이후 현재까지 총 16건의 한의학 관련 KS가 제정됨

국내 표준화 활동현황

KS번호

표준명

내용

제정일

KS P ISO 3104 

일반식 온구기 

의료에 사용하는 일반식 온구기에 대하여 규정

1979.05.02

(제정)

2018.08.22

(개정

KS P ISO 17218

일회용멸균 호침

한의학 의료용으로 사용하는 스테인리스 강선으로 제작된 일회용 멸균호침의 치수재료품질시험포장 및 표기 방법에 대하여 규정

2009.08.20

(제정)
2016.12.20

(개정)

KS P 3008

이침

한의학 의료용으로 사용하는 스테인리스 강재로 제작된 이침의 치수재료품질시험포장 및 표기 방법에 대하여 규정

2010.12.30

(제정)
2015.07.31

(확인)

KS P 3009

피내침

한의학 의료용으로 사용하는 스테인리스 강재로 제작된 피내침의 치수재료품질시험포장 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 환자의료인 및 보조 인력의 건강을 보호하기 위한 침시술 안전관리에 대하여 규정

2012.01.02

(제정)
2017.12.29

(확인)

2019.11.25

(폐지)

KS P 2012

한의약 - 침시술감염관리

임상행위를 제외한 침 시술시 고려해야할 사항을 규정

2020.12.30

(제정

KS P 3010

한의약 - 인체 경혈 명칭 및 위치- 14경맥

14경맥의 명칭과 361개 경혈의 명칭위치 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 -  - 일반 요구
사항

의료용으로 사용하는 뜸의 종류뜸을 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 구성재질성능 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)

KS P ISO 2048 

한의약 - 혀 영상 획득 시스템 - 일반 요구사항 

혀 영상 획득 시스템의 성능 및 안전성에 대한 일반 요구사항 규정. 차폐형과 비차폐형 타입의 모든 혀 영상 획득 시스템에 적용

2019.11.25

(제정

KS P ISO 18615 

한의약 - 전자식 요골동맥 맥파분석기 일반 요구사항 

전자식 요골동맥 맥파분석기의 기본 안전성과 성능에 대한 일반 요구사항 규정. 압력 기반의 전자식 요골동맥 맥파분석기에 적용 

2019.11.25

(제정

KS P ISO 20487 

전침용 일회용 침의 시험방법 

전침 시술용 일회용 침의 내식성을 비교하기 위한 공통 시험방법 규정 

2019.11.25

(제정

KS P ISO 21366 

한의약 - 무연뜸기구 일반 요구사항 

무연뜸기구의 성능 및 안전성에 대한 일반 요구사항 규정연기 밀도, 뜸 시술 온도, 유해가스 농도 및 그에 대한 시험법 규정 

2019.11.25

(제정

KS P ISO 2080 

한의약 - 탕약 식별을 위한 표기 가이드라인 

한약규격품을 사용하여 탕전실에서 조제된 탕약의 최소 포장단위에 대한 고유한 식별 라벨 및 최소한의 표기에 관한 사항 규정 

2020.12.30

(제정

KS P ISO 2081 

한의약 - 뜸 시술공간 일반 요구사항 

뜸 시술공간의 실내 공기 질, 화재 안전 요소를 규정하고 이를 시험하기 위한 시험법과 시설기준 규정 

2020.12.30

(제정

  ※ KS P 3000은 폐지되었으며 KS P 1928로 대체되었음 (2017.9.29)
   KS P 2000은 폐지되었으며 KS P 2012로 대체되었음 (2020.12.30)