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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 23건의 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)

2021.06.28

(개정

KS P ISO 17218

일회용 멸균 호침

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

2009.08.20

(제정)
2021.09.30

(확인)

KS P 3008

이침

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

2010.12.30

(제정)
2021.06.28

(개정)

KS P 3009

피내침

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

2010.12.30

(제정)
2021.06.28

(개정)

KS P 2000

한의약 - 침 시술 안전관리

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 - 침시술 감염 관리

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)
2019.11.25

(개정)

KS P 1927

한의약 - 한약 추출기

설계압력이 0.1 MPa 미만인 압력식 및 무압력식 한약 추출기의 일반 요건에 대하여 규정

2017.09.29

(제정)

2022.12.28

(개정)

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)

2022.12.28

(개정)

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)

2023.12.28

(개정

KS P ISO 2048 

한의약 혀 영상 획득 시스템 일반 요구사항 

혀 영상 획득 시스템의 성능 및 안전성에 대한 일반 요구사항 규정차폐형과 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 규정압력 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 규정.  연기 밀도뜸 시술 온도유해가스 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 질화재 안전 요소를 규정하고 이를 시험하기 위한 시험법과 시설기준 규정 

2020.12.30

(제정

 KS P 2179 한의약 — 유리 부항기컵 안쪽 공간의 열원으로 발생된 음압을 가하는 유리 부항기의 요구조건을 규정, 유리 부항기의 구성, 재료, 성능, 포장, 라벨 부착 관련 요구조건과 적합한 검사 방법들을 포함하며, 일회용 유리 부항기와 재사용 유리 부항기에 적용, ISO 19611:2017이 규정하는 공기 배출형 부항기에는 적용하지 않음 2022.12.28
 (제정)
 KS P 2180 한의약 — 롤러형 일회용   피부침롤러형 일회용 피부침의 기본적 안전성 및 필수성능 요구사항에 대하여 규정함, 피부에 침투 가능한 롤러형 피부침에 적용하며, 롤러형 피부침의 구조 및 치수, 재료 및 성능 요구사항, 외관 및 청결도, 내부식성, 멸균성, 포장 및 표기에 대하여 규정함, 탭핑형 피부침이나 재사용 가능한 롤러형 피부침에는 적용하지 않음 2022.12.28
 
(제정)
 KS P 2182 한의약 — 저출력 레이저침 기기저출력 레이저침 기기에 대한 요구사항과 시험 방법을 명시, 고출력 레이저침 기기에는 적용되지 않으며 복합 기기의 경우 레이저 기능에만 적용 2022.12.28
 
(제정)
 KS P 2237 한의약 — 부항 안전 관리공기 흡입 또는 배출에 사용되느니 부항기에 대한 안전 관리를 규정함. 플라스틱, 유리, 고무, 세라믹 또는 실리콘 제조 부항겁을 포함하는 부항기에 적용되며, 천연 재료로 만든 부항컵이나 자성 또는 적외선과 같은 추가 기능이 포함된 부항기에는 적용되지 않음 2023.12.26
 
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 KS P ISO   24571 한의약 — 전침기의 안전 및 필수성능 요구사항전침기(electro-acupuncture, EA)의 기본 안전 및 필수 성능에 관한 일반 요구사항을 규정함, 침, 경피신경 전기자극기 또는 신경 및 근육 전기자극기에는 적용되지 않음 2023.12.26
 (제정)
  ※ KS P 3000은 폐지되었으며 KS P 1928로 대체되었음 (2017.9.29)
   KS P 2000은 폐지되었으며 KS P 2012로 대체되었음 (2020.12.30)