TCVN/TC 210 - Quản lý chất lượng trang thiết bị y tế

Số hiệu
TCVN/TC 210
Tên Ban kỹ thuật
Quản lý chất lượng trang thiết bị y tế
Ban kỹ thuật Tiêu chuẩn quốc tế tương ứng
Phạm vi
Tư vấn kỹ thuật các hoạt động trong lĩnh vực tiêu chuẩn Quản lý chất lượng Trang thiết bị y tế
Liên hệ

Đoàn Bích Nga, Thư ký

Phòng Tiêu chuẩn Chất lượng 3 - Hóa chất, dầu khí, khoáng sản, xây dựng

Viện Tiêu chuẩn Chất lượng Việt Nam

Số 8 Hoàng Quốc Việt, phường Nghĩa Đô, quận Cầu Giấy, TP. Hà Nội

Điện thoại: 024.38361 467  -  Email: ngadb@yahoo.com

Thành viên Ban kỹ thuật
  • Nguyễn Minh Tuấn (Trưởng ban)
  • Đoàn Bích Nga (Thư ký)
Danh sách dự thảo đang thực hiện
  • Traditional Chinese medicine -- General requirements for smokeless moxibustion devices
  • Traditional Chinese medicine -- General requirements for smokeless moxibustion devices
  • Health informatics -- Classification of traditional Chinese medicine datasets
  • Health informatics -- Classification of traditional Chinese medicine datasets
  • Traditional Chinese medicine --Therapeutic fumigation devices
  • Traditional Chinese medicine --Therapeutic fumigation devices
  • Traditional chinese medicine -- Guidelines for chinese materia medica specification
  • Traditional chinese medicine -- Guidelines for chinese materia medica specification
  • Traditional Chinese medicine- Determination of pesticide residues in herbal medicines used in Traditional Chinese Medicine
  • Traditional Chinese medicine- Determination of pesticide residues in herbal medicines used in Traditional Chinese Medicine
  • Traditional Chinese medicine- Determination of Sulfur Dioxide in herbal medicines used in Traditional Chinese Medicine
  • Traditional Chinese medicine- Determination of Sulfur Dioxide in herbal medicines used in Traditional Chinese Medicine
  • Traditional Chinese medicine -- Abdominal physiological parameter detector
  • Traditional Chinese medicine -- Abdominal physiological parameter detector
  • Traditional Chinese medicine -- Infrared moxibustion-like instrument
  • Traditional Chinese medicine -- Infrared moxibustion-like instrument
  • Traditional Chinese medicine -- Gastrodia elata tuber
  • Traditional Chinese medicine -- Gastrodia elata tuber
  • Traditional Chinese Medicine--Determination of irradiated Traditional Chinese Medicine using photostimulated luminescence
  • Traditional Chinese Medicine--Determination of irradiated Traditional Chinese Medicine using photostimulated luminescence
  • Traditional Chinese medicine --Storage requirements for Chinese materia medica and decoction pieces
  • Traditional Chinese medicine --Storage requirements for Chinese materia medica and decoction pieces
  • CIB on whether or not to further consider including the education and training of practitioners within the scope of TC249
  • CIB on whether or not to further consider including the education and training of practitioners within the scope of TC249
  • Traditional Chinese Medicine- Determination of microorganism in herbal medicines used in Traditional Chinese Medicine
  • Traditional Chinese Medicine- Determination of microorganism in herbal medicines used in Traditional Chinese Medicine
  • ISO/DTS 22773 Health Informatics-Categorial structures for representation of decocting process in Traditional Chinese medicine
  • ISO/DTS 22773 Health Informatics-Categorial structures for representation of decocting process in Traditional Chinese medicine
  • TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS FOR HERBAL RAW MATERIAL AND MATERIA MEDICA
  • TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS FOR HERBAL RAW MATERIAL AND MATERIA MEDICA
  • Traditional Chinese medicine - Angelica sinensis root
  • Traditional Chinese medicine - Angelica sinensis root
  • Categories of clinical terminological systems to support integration of Traditional Chinese medicine and western medicine
  • Categories of clinical terminological systems to support integration of Traditional Chinese medicine and western medicine
  • Traditional Chinese medicine -- Astragalus mongholicus root
  • Traditional Chinese medicine -- Astragalus mongholicus root
  • ISO/DTS 21831.2 Health Informatic – Information model of processing Chinese materia medica
  • ISO/DTS 21831.2 Health Informatic – Information model of processing Chinese materia medica
  • ISO/DTS 23303 Health Informatics -- Categorial structure for Chinese materia medica products manufacturing process
  • ISO/DTS 23303 Health Informatics -- Categorial structure for Chinese materia medica products manufacturing process
  • Traditional Chinese medicine -- Pulse waveform format
  • Traditional Chinese medicine -- Pulse waveform format
  • Traditional Chinese medicine --Therapeutic fumigation devices
  • Traditional Chinese medicine --Therapeutic fumigation devices
  • Traditional Chinese Medicine --General requirements for herbal raw material and materia medica
  • Traditional Chinese Medicine --General requirements for herbal raw material and materia medica
  • Traditional Chinese medicine -- Dendrobium officinale stem
  • Traditional Chinese medicine -- Dendrobium officinale stem
  • Traditional Chinese medicine -- Salvia miltiorrhiza root and rhizome
  • Traditional Chinese medicine -- Salvia miltiorrhiza root and rhizome
  • Traditional Chinese medicine -- Ganoderma lucidum fruiting body
  • Traditional Chinese medicine -- Ganoderma lucidum fruiting body
  • Traditional Chinese medicine -- Isatis indigotica root
  • Traditional Chinese medicine -- Isatis indigotica root
  • Traditional Chinese medicine -Thread embedding acupuncture needle for single use
  • Traditional Chinese medicine -Thread embedding acupuncture needle for single use
  • Traditional Chinese medicine -- Vocabulary -- Part 2: Processing of Chinese materia medica
  • Traditional Chinese medicine -- Vocabulary -- Part 2: Processing of Chinese materia medica
  • Traditional Chinese medicine -- General requirements of electric radial pulse tonometric device
  • Traditional Chinese medicine -- General requirements of electric radial pulse tonometric device
  • Traditional Chinese medicine -- Lonicera japonica flower
  • Traditional Chinese medicine -- Lonicera japonica flower
  • Traditional Chinese medicine -- Gastrodia elata tuber
  • Traditional Chinese medicine -- Gastrodia elata tuber
  • Traditional Chinese medicine -- Computerized tongue image analysis system -- Part 1: General requirements
  • Traditional Chinese medicine -- Computerized tongue image analysis system -- Part 1: General requirements
  • Traditional Chinese medicine -- Angelica sinensis root
  • Traditional Chinese medicine -- Angelica sinensis root
  • Traditional Chinese medicine -- Guidelines and specification for Chinese materia medica
  • Traditional Chinese medicine -- Guidelines and specification for Chinese materia medica
  • Traditional chinese medicine -- Priority list for developing standards for single herbal medicines in ISO/TC249
  • Traditional chinese medicine -- Priority list for developing standards for single herbal medicines in ISO/TC249
  • Traditional Chinese medicine -- Determination of benzopyrene in processed natural products
  • Traditional Chinese medicine -- Determination of benzopyrene in processed natural products
  • TCM- Dermal Needle for single use -- Part 1: Tapping type
  • TCM- Dermal Needle for single use -- Part 1: Tapping type
  • TCM- Dermal Needle for single use -- Part 2: Roller Type
  • TCM- Dermal Needle for single use -- Part 2: Roller Type
  • Traditional Chinese Medicine-Glehnialittoralis root
  • Traditional Chinese Medicine-Glehnialittoralis root
  • Traditional Chinese Medicine -- Glycyrrhiza uralensis root and rhizome
  • Traditional Chinese Medicine -- Glycyrrhiza uralensis root and rhizome
  • Traditional Chinese Medicine-Vocabulary for Diagnostics -- Part 1: Tongu
  • Traditional Chinese Medicine-Vocabulary for Diagnostics -- Part 1: Tongu
  • Traditional Chinese Medicine-Vocabulary for Diagnostics -- Part 2: Pulse
  • Traditional Chinese Medicine-Vocabulary for Diagnostics -- Part 2: Pulse
  • Traditional Chinese Medicine --Processed Aconitum carmichaeliilateral root
  • Traditional Chinese Medicine --Processed Aconitum carmichaeliilateral root
  • Traditional Chinese Medicine -- requirements for process traceability system of Chinese materia medica and decoction pieces -- Part 1: components
  • Traditional Chinese Medicine -- requirements for process traceability system of Chinese materia medica and decoction pieces -- Part 1: components
  • Traditional Chinese Medicine -- requirements for process traceability system of Chinese materia medica and decoction pieces -- Part 2: electronic labelling
  • Traditional Chinese Medicine -- requirements for process traceability system of Chinese materia medica and decoction pieces -- Part 2: electronic labelling
  • Traditional Chinese Medicine -- Saposhnikoviadivaricata root and rhizome
  • Traditional Chinese Medicine -- Saposhnikoviadivaricata root and rhizome
  • Traditional Chinese Medicine--Bupleurum chinense and Bupleurum scorzonrifolium root
  • Traditional Chinese Medicine--Bupleurum chinense and Bupleurum scorzonrifolium root
  • Traditional Chinese medicine -- Panax quinquefolium root
  • Traditional Chinese medicine -- Panax quinquefolium root
  • Traditional Chinese medicine -- Coding System for Chinese Patent Medicines -- Part 1: Coding Rules
  • Traditional Chinese medicine -- Coding System for Chinese Patent Medicines -- Part 1: Coding Rules
  • Traditional Chinese Medicine -- Gravimetric determination of total ginseng saponins
  • Traditional Chinese Medicine -- Gravimetric determination of total ginseng saponins
  • Traditional Chinese Medicine --Zingiber officinale rhizome
  • Traditional Chinese Medicine --Zingiber officinale rhizome
  • Traditional Chinese Medicine -- General information structure for herbal raw material
  • Traditional Chinese Medicine -- General information structure for herbal raw material
  • Traditional Chinese Medicine-Commercial grades of Lonicera japonica flower
  • Traditional Chinese Medicine-Commercial grades of Lonicera japonica flower
  • Traditional Chinese medicine -- Lycium barbarum and Lycium chinense fruit
  • Traditional Chinese medicine -- Lycium barbarum and Lycium chinense fruit
  • Traditional Chinese medicine -- Determination of Aflatoxins in natural products by LC-FLD
  • Traditional Chinese medicine -- Determination of Aflatoxins in natural products by LC-FLD
  • Consultation on ISO/NP21310 document type
  • Consultation on ISO/NP21310 document type
  • Traditional Chinese medicine -- General requirements for smokeless moxibustion devices
  • Traditional Chinese medicine -- General requirements for smokeless moxibustion devices
  • Traditional Chinese medicine -- Determination of selected Aconitum alkaloids by HPLC
  • Traditional Chinese medicine -- Determination of selected Aconitum alkaloids by HPLC
  • Traditional Chinese medicine --Therapeutic fumigation devices
  • Traditional Chinese medicine --Therapeutic fumigation devices
  • Traditional Chinese Medicine--Andrographis paniculata herb
  • Traditional Chinese Medicine--Andrographis paniculata herb
  • Traditional Chinese medicine -- Pulse waveform format
  • Traditional Chinese medicine -- Pulse waveform format
  • Traditional Chinese medicine -- Electric heating moxibustion equipment
  • Traditional Chinese medicine -- Electric heating moxibustion equipment
  • Traditional Chinese medicine -- Quality and safety of natural materials and manufacturing products made with natural materials -- Part 1: General requirements
  • Traditional Chinese medicine -- Quality and safety of natural materials and manufacturing products made with natural materials -- Part 1: General requirements
  • Traditional Chinese medicine -- Quality and safety of natural materials and manufacturing products made with natural materials -- Part 2: Identity testing
  • Traditional Chinese medicine -- Quality and safety of natural materials and manufacturing products made with natural materials -- Part 2: Identity testing
  • Traditional Chinese medicine -- Quality and safety of natural materials and manufacturing products made with natural materials -- Part 3: Part 3: Testing of the absence of contaminants
  • Traditional Chinese medicine -- Quality and safety of natural materials and manufacturing products made with natural materials -- Part 3: Part 3: Testing of the absence of contaminants
  • Traditional Chinese medicine -- Quality and safety of natural materials and manufacturing products made with natural materials -- Part 4: Part 4: Testing of Preservatives and non wanted compounds
  • Traditional Chinese medicine -- Quality and safety of natural materials and manufacturing products made with natural materials -- Part 4: Part 4: Testing of Preservatives and non wanted compounds
  • Traditional Chinese Medicine -- Codonopisis pilosula root
  • Traditional Chinese Medicine -- Codonopisis pilosula root
  • Traditional Chinese Medicine-Paeonia lactiflora root
  • Traditional Chinese Medicine-Paeonia lactiflora root
  • Traditional Chinese medicine -- Traditional glass cupping device
  • Traditional Chinese medicine -- Traditional glass cupping device
  • Traditional Chinese medicine -- Ginseng seeds and seedlings -- Part 1: Panax ginseng C.A. Meyer
  • Traditional Chinese medicine -- Ginseng seeds and seedlings -- Part 1: Panax ginseng C.A. Meyer
  • Traditional Chinese medicine -- Detection of irradiated natural products by photostimulated luminescence
  • Traditional Chinese medicine -- Detection of irradiated natural products by photostimulated luminescence
  • Traditional Chinese medicine -- Determination of pesticide residues in natural products by G
  • Traditional Chinese medicine -- Determination of pesticide residues in natural products by G
  • Traditional Chinese medicine -- Determination of Sulfur Dioxide in natural products by titration
  • Traditional Chinese medicine -- Determination of Sulfur Dioxide in natural products by titration
  • Traditional Chinese medicine -- Microscopic examination on medicinal herbs
  • Traditional Chinese medicine -- Microscopic examination on medicinal herbs
  • Traditional Chinese medicine -- Computerized tongue image analysis system -- Part 3: Colour chart
  • Traditional Chinese medicine -- Computerized tongue image analysis system -- Part 3: Colour chart
  • Traditional Chinese Medicine -- General requirements for the basic safety and essential performance of electro-acupuncture stimulator
  • Traditional Chinese Medicine -- General requirements for the basic safety and essential performance of electro-acupuncture stimulator
  • Traditional Chinese medicine -- Determination of Aflatoxins in natural products by LC-FLD
  • Traditional Chinese medicine -- Determination of Aflatoxins in natural products by LC-FLD
  • Traditional Chinese medicine -- Astragalus mongholicus root
  • Traditional Chinese medicine -- Astragalus mongholicus root
  • Traditional Chinese Medicine -- Single-use sterile acupotomy needle
  • Traditional Chinese Medicine -- Single-use sterile acupotomy needle
  • Comment on the revised Strategic Business Plan of ISO/TC249 (2019)
  • Comment on the revised Strategic Business Plan of ISO/TC249 (2019)
  • Traditional Chinese medicine -- Lycium barbarum and Lycium chinense fruit
  • Traditional Chinese medicine -- Lycium barbarum and Lycium chinense fruit
  • Traditional Chinese medicine --Storage requirements for raw materials and decoction pieces
  • Traditional Chinese medicine --Storage requirements for raw materials and decoction pieces
  • Đánh giá sinh học đối với trang thiết bị y tế - Phần 16: Thiết kế nghiên cứu độc lực cho sản phẩm phân hủy và ngâm chiết
  • Đánh giá sinh học đối với trang thiết bị y tế - Phần 11: Phép thử độc tính toàn thân
  • Đánh giá sinh học đối với trang thiết bị y tế - Phần 6: Phép thử hiệu ứng tại chỗ sau cấy ghép
  • Đánh giá sinh học trang thiết bị y tế - Phần 5: Phép thử độc tính tế bào in vitro
  • Đánh giá sinh học trang thiết bị y tế – Phần 4: Chọn phép thử tương tác với máu
  • Đánh giá sinh học trang thiết bị y tế - Phần 2: Yêu cầu sử dụng động vật
  • Đánh giá sinh học trang thiết bị y tế - Phần 3: Phép thử độc tính di truyền, khả năng gây ung thư và độc tính sinh sản
  • Trang thiết bị y tế - Ký hiệu sử dụng với nhãn trang thiết bị y tế, ghi nhãn và cung cấp thông tin – Phần 2: Xây dựng ký hiệu, lựa chọn và đánh giá xác nhận
  • Trang thiết bị y tế - Ký hiệu sử dụng với nhãn trang thiết bị y tế, ghi nhãn và cung cấp thông tin – Phần 1: Yêu cầu chung