��ࡱ�>�� UW����T�������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� �R��Gbjbj222NjX�gjX�g- ���������������������82\�$��""���������!�!�!�!�!�!�!$�$�Y'6�!u�������!����H;"zzz�������!z��!zzr�T� �������Ak��������R��!Q"0�"���'d�'� �'�� ��z������!�!z����"�������������������������������������������������������������������������'����������, �: Confirmation Check sheet for a New Work Item Proposal by Proposer kX�Q�f N0h�yO&^eg�v�vY ��^��D�/e�dPg�e0 3-7 Product or service used in 5 and more countries���f�N�Tb g�R(W5*N�S�N N�V�[�0W:S ��^(u ��^��D�/e�dPg�e0 4-1 Feasibility for achieving consensus on the ISO deliverable���f�cHhb:NISO�e�N���_qQƋ�v�SL�'` ��_���e�^��D�/e�dPg�e0 4-2 Recommended priority for the development of the ISO deliverable���f�cHh6R�[:NISO�e�N�v�cP�OHQ�~ ��_���e�^��D�/e�dPg�e0 �N0/e�dPg�e /e�dPg�e��(u-N0�ekX�QTN�N �-N�e�^�[hQN�0 9hnc�cHh�[E��`�Q �(W�_���e�c�O/e�dPg�e �v^ c�^�ShƋnZi0 N0ISO/TC249�]\O��V ISO Technical Committee 249 Traditional Chinese Medicine (ISO/TC 249) focuses on the field of medical systems derived from ancient Chinese medicine which are able to share one common set of standards. Both traditional and modern aspects of these systems are included. ISO/TC 249 develops standards for quality and safety of raw materials, manufactured products and medical devices and informatics, including service standards limited to involving the safe use and delivery of devices and medicines*, but not including the clinical practice or application of those products. Its domains of work are kept under review and modified in response to actual needs. �* The committee agreed on the following definition of  safe use and delivery of medicines and devices : Definition: risk management of processing, manufacturing, packaging, labelling and the presentation, storage, re-use, servicing of devices, and disposal of those products. � �V0ISO/TC249TWG�]\O��V�TOHQ�~ 1 Working Group 1 Title: Quality and safety of raw materials and traditional processing Scope: The scope of WG1 is to create standards related to raw materials at any stage up to and including harvest of a plant ingredient and collection of an animal or mineral ingredient, and the traditional processing of raw materials. Work plan and priority: 1) Standards for raw materials used in or as traditional Chinese medicine with high priority identified by WG1 based on a priority list of single herbs as follow: �Ongoing projects: Salvia miltiorrhiza root and rhizome, Ganoderma lucidum fruiting body, Isatis indigotica root, Dendrobium officinale stem, Lonicera japonica flower, Gastrodia elata tuber, Astragalus mongholicus root, Angelica sinensis root, Lycium barbarum and Lycium chinense fruit, Astragalus root (Astragalus membranaceus), and Platycodon grandiflorum root; � Top 100 herbs in the Priority list of N600. 2) Detection methods related to the safety of herbs, including: � Detection method of toxins; � Detection method of unwanted substances. 3) Standards for improving the quality of herbs, including: � General requirements for herbal raw material and materia medica; � General requirements for primary processing of raw materials. 2 Working Group 2 Title: Quality and safety of TCM manufactured products. Scope: The scope of WG2 is to create standards for testing, processing (other than traditional processing) and manufacturing of TCM and related products, from starting materials to finished products, in a framework of quality and safety. Work plan and priority: The work priority within ISO /TC 249/WG 2 is to develop standards which contribute to the framework of manufactured TCM products. Priority is given to generic standards such as, � ISO/NP 19609-1, Quality and Safety of natural materials and manufacturing products made with natural materials used in and as traditional Chinese medicine (TCM) � Part 1: General � ISO/NP 19609-2, 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 3 Working Group 3 Title: Quality of acupuncture needles and safe use of acupuncture. Scope: The scope of WG3 is standardization in the field of quality of acupuncture needles and safe use of acupuncture, not including the clinical treatment or efficacy of acupuncture. Work plan and priority: a) To ensure the consistent understanding of the scope of WG3 under the guidance of ISO/TC249 to substantially cont�����������������ij��{iWHW4)h�adhI,�CJaJ&h�adh�}H6�CJOJPJQJaJo(h�x�CJOJPJQJaJo(#h�adh dCJOJPJQJaJo(#h�adh�}HCJOJPJQJaJo(#h�adh�l!CJOJPJQJaJo(#h�adh�}H5�CJOJPJQJaJ&h�adh�}H5�CJOJPJQJaJo( h�}Hh�\}CJOJPJQJaJ%h�h.8B*CJOJPJQJph(h�h�\}B*CJOJPJQJo(ph%h�h�\}B*CJOJPJQJph���� 4 � � � L ���(��t������������������������  & FdhWDgd�ad  & FdhWDgd�addhgd�ad���WD^��`�gd�1CJOJPJQJaJ#h�adh#>1CJOJPJQJaJo(#h�adh�1PCJOJPJQJaJo(#h�adh�0�CJOJPJQJaJo(#h�adh�'�CJOJPJQJaJo(#h�adh�l!CJOJPJQJaJo( h�adh�l!CJOJPJQJaJ#h�adh�}HCJOJPJQJaJo(&h�adhI,�6�CJOJPJQJaJo(#h�adhI,�6�CJOJPJQJaJ� � �   b d v x � � � � �   H J L T � � P R x � �  lt���ʸ�������ʸ��ʩ�ۗ�����������tct h�adh�L~CJOJPJQJaJ#h�adh�L~CJOJPJQJaJo( h�adh�l!CJOJPJQJaJ#h�adh&�CJOJPJQJaJo(helCJOJPJQJaJo(#h�adh�l!CJOJPJQJaJo( h�adh#>1CJOJPJQJaJ#h�adh�Y/CJOJPJQJaJo(#h�adh#>1CJOJPJQJaJo(#t|�����.8x��������  ������۸۸�����ۃۦ�qq۸_N_N h�adhFhUCJOJPJQJaJ#h�adhFhUCJOJPJQJaJo(#h�adh�-nCJOJPJQJaJo(#h�adh�F�CJOJPJQJaJo( h�adh�u�CJOJPJQJaJ#h�adh�u�CJOJPJQJaJo( h�adh�L~CJOJPJQJaJ#h�adh+X#CJOJPJQJaJo(#h�adh�L~CJOJPJQJaJo(#h�adh�A�CJOJPJQJaJo(��TV~������&(0�����6Lvx�����������������udduR@#h�adh�CjCJOJPJQJaJo(#h�adh�'�CJOJPJQJaJo( h�adh�0�CJOJPJQJaJ#h�adh�0�CJOJPJQJaJo(#h�adh^b�CJOJPJQJaJo( h�adh�tCJOJPJQJaJ#h�adh�tCJOJPJQJaJo( h�adhFhUCJOJPJQJaJhC/�CJOJPJQJaJo( h�adhj�CJOJPJQJaJ#h�adhj�CJOJPJQJaJo(���24Z\rt��������������˹�肋�p^M9&h�adh�l5�CJOJPJQJaJo( h�adh�l!CJOJPJQJaJ#h�adh�RnCJOJPJQJaJo( h�adh oCJOJPJQJaJ#h�adh oCJOJPJQJaJo(#h�adh�l!5�CJOJPJQJaJ&h�adh�l!5�CJOJPJQJaJo(#h�adh�'�CJOJPJQJaJo(#h�adhP`eCJOJPJQJaJo(#h�adh�0�CJOJPJQJaJo( h�adh�0�CJOJPJQJaJ���6b��D��J��$Bm��, ? x g!���������������������� dh7$8$H$gd�ad $dha$gd�ad ��dhWDd`��gd�addhgd�ad  & FdhWDgd�ad�����468^`b������������ɸ���������o[H$h�adh�l5�6�OJQJ\�]�^J'h�adh�DENRbz���������#$��������������ұҝҝ��ҝҝҝ���ҝҝҝ��ҝҝ����ұ����)h�adh� ? F w x  ?!f!g!!�!�!"""1"2"?"�"�"�"?#�#�#�#�#�#�#�#�#$�������������ƹ������������������������������w"h�adh�l5�CJOJQJ\�aJh�adh�\-OJQJ^Jh�adh�l5�OJQJ\�^J$h�adh�l5�6�OJQJ\�]�^Jh�adh�lOJQJ^Jh�adh�a$gd�addhgd�ad $dha$gd�ad$?$�$�$�$�$?%@�@�@A�A�AB.B/B�B�B�B�B CCC/CZC[CaCbC/D}D~D�D�D/E0EBECEJEfEgEnE/F4F5FMFNF�F�F�F�F/GzG{G�G�G�G������������������îÞ��Þ���Þ��îÞ�Þ��Þ�������îÞ!h�adh�\-5�OJQJ\�^Jo(h�adh�l5�OJQJ\�^J$h�adh�l5�6�OJQJ\�]�^JUh�adh�lOJQJ^J"h�adh�l5�CJOJQJ\�aJh�adh m'CJOJQJaJh�adh�lCJOJQJaJ7ribute to a proposal�s preparation and the progression of every specific standard on acupuncture and its safe use and especially avoid repetition of the common issues during the development of individual standards on acupuncture and its safe use. b) To ensure the consistent understanding of the terms and the definitions in standard development and to draw up a specific and applicable standards framework (roadmap) of WG3. c) Quality control and improvement of projects based on the criteria of standard prioritization and project management procedures. d) Standardization of the quality and safety of all types of acupuncture needles within the scope of WG3. e) Project development on safe use of acupuncture consistent with the definition of �safe use�. 4 Working Group 4 Title: Quality and safety of medical devices other than acupuncture needles Scope: The scope of WG 4 is to develop standards for quality, safety and safe use of medical devices other than acupuncture needles, not including clinical treatment and efficacy of medical devices. Exclusion: the safety and/or performance of electromedical equipment (see ISO/TC249/JWG6). Work plan and priority: WG4 considers level of risk, scale of use, lack of standards or harmonization, importance for international trade and commerce as prioritizing factors. 5 Working Group 5 Title: Terminology and informatics Scope: The scope of WG5 is standardization of TCM nomenclatures, terminology, classification and ontology. Health informatics technology, as it relates to TCM, shall be addressed within the scope of JWG1. Work plan and priority: a) prioritize the task to make the terms and informatics to be used by other WGs b) industrial benefits and market needs should be considered in WG projects preferentially c) WHO terminology standard should be reviewed closely prior to submitting the new proposals in order to avoid the redundancy 6 Joint Working Group 1 with ISO/TC 215 Title: Informatics Scope: Health informatics technology related to TCM.     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