Academie voor Chinese Geneeswijze Qing-Bai

Academie voor Chinese Geneeswijze Qing-Bai

Academie voor Chinese Geneeswijze Qing-Bai is sinds januari 2010 actief betrokken bij het opstellen van kwaliteitsnormen voor de TCM en is de vice-voorzitter van de normcommissie 330249. Qing-Bai ondersteunt hiermee de professionalisering van het vakgebied TCM. Dit is essentieel voor de toekomst van TCM. Voor Qing-Bai is niet alleen professionele educatie belangrijk. Qing-Bai werkt ook actief aan een professioneel vakgebied waar de afgestudeerde TCM therapeut in kan werken. Het opstellen van ISO kwaliteitsnormen is een wereldwijd gebeuren en de eerste normen zijn al geaccepteerd en klaar voor gebruik in Nederland. Normen worden voor veel gebieden binnen de TCM opgesteld. Voorbeelden zijn: • het kweken van Chinese kruiden. • de fabricage van acupunctuurnaalden. • termen en definities voor diagnose, acupunctuur, Chinese kruiden, tuina, etc. • informatiesystemen (vergelijk SNOMED). • apparatuur voor tongdiagnose. • praktijkvoering. • educatie. • etc,.  Op dit moment wordt er gewerkt aan het opstellen voor normen voor praktijkvoering en educatie. Dit kan ook belangrijk zijn voor jou als therapeut. Iedereen kan zijn/haar steentje bijdragen aan de professionalisering van het vakgebied TCM. Voor meer informatie kun je terecht bij het Nederlands Normalisatie Instituut (NEN) te Delft. Op de volgende pagina’s vind je meer informatie omtrent dit unieke wereldwijde project. • Presentatie Nederlandse Normontwikkelingstraject Praktijkvoering en Opleiding TCM. • Presentatie Kick-off bijeenkomst Nederlandse normontwikkelingstraject. • International Newsletter ISO/TC 249 TCM.

Nederlandse)Normontwikkelingstraject)Prak4jkvoering)en)Opleiding)TCM)

26/05/15)

Presenting •  Kris Oosting –  Active member NC330249 TCM. –  Expert Member ISO/TC 249 WG Health Informatics - Semantic Content and Informatics on TCM. –  Principal Teacher Chinese Herbal Medicine, Teacher TCM Fundamentals at Academy Qing-Bai (HBO docent VU Amsterdam). –  Co-founder TCM Classics Research Institute. –  Member of the Expert Research Committee for Diagnosis and Treatment of the World Federation of Chinese Medicine Societies. –  Practicing Acupuncture & Herbal Medicine since 2003. –  Previous 15 yrs SW Development Quality & Metrics.

Nederlandse Normontwikkelingstraject Praktijkvoering en Opleiding TCM 20 februari 2013, NEN (Delft) Kris Oosting – Vice-chairman

1)

Quality in Early TCM

Quality in Early TCM Disease Prevention

•  Quality has been an integral part of TCM. •  Levels of Practitioners: Sù)Wèn)2)

Superior Practitioner

Líng)Shū)55)

Superior Practitioner Inferior Practitioner

Nán)Jīng)77)

Superior Practitioner Mediocre Practitioner

Jīn)Guì)Yào)Lüè)1) Superior Practitioner

2)

Level%

Success%Rate%

Superior) )

90%U100%)

Mediocre/ Ordinary) )

70%)<90%)

Inferior) )

60%)<70%)

Aspect

Chinese Application

Disease prevention

Obey the laws and avoid animal harm, restrain sexual activity, regulate heat, cold, bitterness, sourness, acridity, and sweetness with clothing and diet, and not let his body become debilitated.

Early treatment of disease

Exercises (dăoyĭn), exhaling and inhaling (tùnà), acupuncture and moxibustion, or medicinal paste rubbing (gāomó).

Prevention of disease Passage and Transmutation

Guidelines and strategies according to the Shāng Hán Lùn and Jīn Guì Yào Lüè.

Translate to current clinical practice.

3)

4)

On the Absolute Sincerity of Great Physicians

On the Absolute Sincerity of Great Physicians

•  •  •  •  •  •  •  •  • 

•  Neither dangerous mountain passes nor the time of day. •  Neither weather conditions nor hunger, thirst nor fatigue should keep him from helping wholeheartedly. •  According to the reputations of medicine, it is not permissible to be talkative and make provocative speeches. •  To make fun of others and raise one’s voice, to decide over right and wrong. •  And to discuss other people and their business. •  Finally, it is inappropriate to emphasize one’s reputation, to belittle the rest of the physicians, and to praise one’s own virtue.

He/She has to be mentally calm Should not give way to wishes and desires Develop first a marked attitude of compassion Commit to take effort to save every living creature Should not pay attention to status, wealth, or age Neither whether a person is attractive or unattractive Whether he is an enemy or friend Whether Chinese or foreigner Whether educated or uneducated Sun Simiao around 580 5)

6)

1)


Shang Han Lun – Huai Bing

26/05/15)

Current to Desired Situation Controlled)

•  Zhāng Zhòngjĭng, 150-219. •  Personal Motive: lost two-third of family members due to epidemics. •  Clinical and systematic. •  Huai Bing: syndromes induced by mistreatment and what to do about it. •  From the TCM point of view: side-effects are the result of mistreatment, and belong to Huai Bing. •  Western medicines and their side-effects belong to this category. Legalized Huai Bing.

Current) Situa4on)

Desired) Situa4on)

Desired)

Normal)

7)

A Process

Early TCM Processes Data Collection Four Methods of Diagnosis (Qin Yueren, also called Bian Que (401-314 B.C.))

A sequence of steps performed for a given purpose. A process is what you do.

Inspec4on)

Procedures)and) methods)deﬁning)the) rela4onships)of)tasks)

People)with)skills,) training,)and)) mo4va4on)

8)

Listening)&) Olfac4on)

Inquiry)

Palpa4on)

Data Collection & Organization, Strategy Shang Han Lun (Zhang Zhongjing circa 150-219)

TCM) Process) Tools)and) equipment)

Principles)

Methods)

Formulas)

Ingredients /)Points)

Disease)

Loca4on)

Root/Cause)

Progress)&) Prognosis)

9)

Current TCM Process Understand)

Control)

Learn)

Collect) Data)

Organize) Data)

Four)Methods) ) 1.)Inspec4on) 2.)Listening)&) Olfac4on) 3.)Inquiry) 4.)Palpa4on)

Syndrome) Diﬀeren4a4on) ) >)300) Syndrome) Descrip4ons,) >)4000)diseases)

Process Maturity

Improve)

Early)Warning)

Determine) Strategy)

Treatment) Methods)

) 18)Main) categories,) combina4ons)

10)

•  The extent to which a specific process is explicitly defined, managed, measured, controlled, and effective.

Perform) Treatment)

)

Treatment)Type) Acupuncture)

Herbal) Medicine)

Tuina)

11)

12)

2)


Process Maturity

26/05/15)

Process Maturity Levels

Process

Characteristic

Without

Ad hoc, occasionally even chaotic, fighting the same crises over and over. Unpredictable.

Beginning

Basic processes established, can repeat earlier successes. Discovering a pattern, and capturing and repeating it.

Established

Process documented, standardized, integrated. Altering the pattern to fit the current situation.

Improved

Detailed measures of process and treatment quality collected. Keep on track toward goals.

Optimal

Continuous process improvement enabled by quantitative feedback.

Con4nuously) improving) process)

Predictable) process) Standard,) consistent) process) Disciplined) process)

Beginning) Process)

ISO

Without) Process)

W. Humphrey: Carnegie Mellon University Prof. J. N. Luftmann: Stevens Institute of Technology School of Management

Op4mal) Process)

Improved) Established) Process) Process) )

Measurement)

13)

14)

Start (New Patient File)

We All Want to Improve

Process Flow Example Process%

Then)you)) can)

Input%

Main)Complaint(s).)Owner:)pa4ent)

Output%

Data)from)Inspec4on.)Owner:)prac44oner)

Descrip6on%

Collect)data)from)the)pa4ent)by)using)the) Inspec4on)method)of)the)four)methods)of) diagnosis.)This)process)is)guided)by)the)main) complaint(s))of)the)pa4ent.)

Skills/ Knowledge%

Knowledge)of)what)to)inspect.) Observa4on)skills.)

Steps%

The)following)can)be)inspected)(not)necessarily)in) this)sequence):) Local)areas:) •  eyes) •  ears)and)nose) •  …)

Then)you)) can)

Then)you)) can)

“You)can’t)control) What)you)can’t)measure”) UTom)DeMarco)

Main Complaint(s)

Inspec4on)

Examples%

B

Nails:)brivle) Eyes:)blurred)vision,)red)

1. Collect Data Inspection Ausculation & Olfaction Inquiry Palpation

Anamnesis

2. Organize Data Pattern Identification Disease Identification

C

Diagnosis

15)

TCM Education

16)

Normalization in TCM •  What can ISO bring to the table?

•  Connect with TCM Process for Practitioners. •  Possible starting point: World Classification Standard for Professional Titles of Chinese Medicine Doctors:

–  –  –  –  –  – 

–  Requirements of Professional Knowledge and Skills for International Chinese Medicine Doctor (Licensed Doctor) –  Example: Chinese Herbal Medicine at Qing-Bai uses curriculum of Bachelor Level of Shandong University of TCM as starting point.

Professionalism of domain. Improved communication Clarity. Basis for process improvement and process measurement. To think about and work on Quality. Clear terminology throughout the domain of TCM. Clear guidelines for software development.

•  >300 TCM students all indicated: this is an important and necessary development for the professionalization of their future profession. •  Patients react positive on this initiative. •  Quality norms are widely accepted in other professions.

17)

18)

3)

Doel bijeenkomst 1. 

Start Nederlands normontwikkelingstraject opleiding en praktijkvoering TCM

2. 

Informeren over Internationale normontwikkeling Traditional Chinese Medicine Informeren over normontwikkeling bij NEN/ISO

3. 

Kick-off bijeenkomst Nederlandse normontwikkelingstraject opleiding en praktijkvoering TCM

4. 

20 februari 2013, NEN (Delft)

Bepalen welke partijen behoefte/belang hebben en actief willen deelnemen aan de Nederlandse/ internationale normontwikkeling op het gebied van Traditional Chinese Medicine

1

2

1st meeting of ISO/TC 249 Traditional Chinese Medicine in Bejing

Internationale normontwikkeling TCM •  Gestart

in 2009 van China •  Doel: To develop international standards supporting the international standardization of TCM •  Initiatief

•  Participating

members:

–  Australia,

Austria, Canada, China, Finland, Germany, Ghana, India, Israël, Italy, Japan, Korea, Mongolia, Singapore, South Africa, Spain, Switzerland, Thailand, Tunesia, United States, Vietnam

•  Observing

members:

–  Barbados,

France, Hong Kong, Lithuania, Ireland, Netherlands, New Zealand, Poland, Sweden, UK

3

Nederlandse normcommissie TCM

Internationale vergaderingen ISO/TC 249 •  1e •  2e

–  Stichting

2010

voor Chinese Geneeswijze Qing-Bai

Nei Tsjing / Hwa To University

–  KNMP –  Kinesis

2011

–  DFS

•  5

–  17

vergadering in Durban, Zuid Afrika

Pharma BB [ExpertSys]

internationale werkgroepen

–  12

2012

–  20-23

- Nederlandse Artsen Acupunctuur Vereniging

–  Academie

vergadering in Korea

–  May

•  4e

–  NAAV

vergadering in Den Haag, Nederland

–  May

•  3e

•  Samenstelling

vergadering in Bejing, China

–  June

4

actieve normontwikkelingstrajecten aankondigingen voor nieuwe trajecten

•  Nederlandse

mei 2013

–  Opleiding

5

initiatief

en praktijkvoering

6

1

WG 1 Quality and safety of raw materials and traditional processing

WG 4 Quality and safety of medical devices other than acupuncture needles

• 

Ginseng seeds and seedlings part 1 Panax ginseng C.A. Meijer

• 

• 

Heavy metals in natural materials of TCM

• 

Computerized tongue diagnosis system

Requirements for basic safety and essential performance for electroacupuncture stimluator •  Gerneral requirements of electric radial pulse tonometric devices

WG 2 Quality and safety of manufactured TCM products WG 3 Quality and safety of acupuncture needles

• 

Electroacupuncture stimulator device for quality

• 

Herbal decoction apparatus

• 

Moxibustion devices

WG 5 Informatics of TCM

• 

Intradermal acupuncture needles

• 

TCM vocabulary part 1 Chinese Materia Medica

• 

Sterile acupuncutre needles for single use

• 

Coding system of Chinese Medicine - part 1

• 

Expert member: Kris Oosting

7

8

industrie overheid

opleiding/ wetenschap missie:

consumenten

•  normontwikkeling •  bevorderen toepassing normen •  kennis en informatie centrum normen

advies

Kick-off bijeenkomst Nederlandse normontwikkelingstraject opleiding en praktijkvoering TCM 20 februari 2013, NEN (Delft)

161 leden

30 leden

onderdeel van netwerk CEN en ISO 9

Wat is een NEN-EN-ISO norm?

Kenmerken NEN-EN-ISO norm Bepaald door de principes: •  openheid •  consensus ⇒  neutraal, breedgedragen referentiedocument •  coherentie ⇒  meerwaarde: geen met elkaar conflicterende normen

•  Openbaar

referentiedocument •  Opgesteld door en voor de markt •  NEN

10

faciliteert het proces en levert eindproduct

•  Status

van een norm wordt bepaald door het gebruik (verwijzing naar een norm in contracten, regelgeving)

Regels en procedures om te waarborgen dat principes worden gerespecteerd

11

12

2

Financiering Normontwikkelingswerk ⇒ Belangrijkste

Flowchart ISO norm Proposal 3

input: expertise en tijd

Acceptance

y e a

⇒ Uitgangspunt

No pay, no play

• 

Kosten voor inzet van NEN moeten gedekt zijn.

• 

Normalisatie is geen algemeen belang , tenzij de overheid dit als zodanig beschouwt.

⇒ Financiering • 

Ontwikkeling door experts (Working Group)

Public Enquiry

Openbare commentaarperiode in 161 landen

Adoption by weighted voice

Definitieve versie opgesteld met commentaren verwerkt

s

ISO

graadmeter marktbehoefte:

Als >71% ja én min. 5 landen participeren

Drafting

PrISO

r

Iedere belanghebbende partij kan een voorstel indienen

Publication of European standard (EN)

Normen zijn er voor en door de markt: als partijen niet bereid zijn normontwikkeling mede te financieren hebben ze kennelijk onvoldoende behoefte aan de norm(en)

Users

Identiek gepubliceerd in 147 landen en tegenstrijdige nationale normen ingetrokken

13

14

Werkzaamheden NEN

Tijdbesteding en taken

Secretariaatsvoering en ondersteuning normalisatie activiteiten Organisatie, informeren normalisatie, agenda, bijwonen & verslaglegging vergaderingen, documentenstroom, contacten, ledenbeheer, financiën

•  Commissieleden bepalen/beïnvloeden inhoud

Bewaken kwaliteitseisen

•  Inspanning = resultaat

Redactie van (concept)normen (conform NEN-eisen), normtechnische adviezen, verwerken commentaar, bewaken onderlinge consistentie van samenhangende normen en relatie met wetgeving, samenstelling en structuur

•  Deelnemen aan nationale NC vergadering (halve dag) •  Voorbereiden & indienen van Nederlandse input

Communicatie Intern tussen NC s, extern informeren en betrekken van belanghebbende partijen, normpromotie, persberichten

•  Bestuderen van documenten van andere landen •  Stemmen en commentaar op internationale voorstellen

Coördinatie en deelname nationaal / internationaal Onderhouden netwerk op beleidsmatig en uitvoerend niveau, nationaal en internationaal (ISO+CEN), documenten infrastructuur, NL inbreng m.b.t. normen verzorgen door commentaar leveren, stemmen en participatie, overname normen, inbrengen nieuwe Nederlandse initiatieven in CEN/ ISO verband

•  Keuze: deelnemen aan internationale vergadering (1-2 dagen)

15

16

Bronnen van informatie •  Handleiding •  NEN

voor Commissieleden

website: www.nen.nl

•  [email protected]

17

3

ISO/TC 249 Newsletter —Vol. 6 (2014 Christmas Edition) Congratulations to the publications of the first two international standards of ISO/TC249 ISO 17218:2014 Sterile acupuncture needles for single use

ISO 17217-1:2014 Traditional Chinese medicine -- Ginseng seeds and seedlings -- Part 1: Panax ginseng C.A. Meyer

ISO17218:2014 Sterile Acupuncture Needle for Single Use has been proposed by SAC since 2011 and published on 3rd Feb., 2014. This international standard which harmonizes and defines the acceptable specifications and the requirements for the sterile acupuncture needles for single use (specialized for filiform needles) not only assists trade and commerce but protect the reputation of acupuncture and the safety of the community.

Led by SAC in 2011 and published on 22nd Apr., 2014, ISO 17217-1:2014 Traditional Chinese medicine -- Ginseng seeds and seedlings -- Part 1: Panax ginseng C.A. Meyer specifies minimum requirements and test methods for ginseng seeds and seedlings, Panax ginseng C.A. Meyer. It is suitable for marketing of cultivated ginseng seeds and seedlings, P. ginseng C.A. Meyer. It is also suitable for quality assurance for ginseng cultivators.

Standards are essential to underpin and protect the use of Traditional Medicine systems that extend into international use. The work in developing ISO 17218:2014 and ISO 17217-1:2014 have demonstrated the benefits of the collaborative and cooperative approach of all the countries and organisations and the strength of the ISO processes. There are many more, important standards being developed within ISO/TC249 which will support the appropriate international use of Traditional Medical systems. ISO link to purchase both standards at

ISO17218:http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59443&commid=598435 ISO 17217-1:http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=63485&commid=598435 INFORMATION RELATED TO ISO/TC 249 TRADITIONAL CHINESE MEDICINE (PROVISIONAL)

1/9

The fifth plenary meeting of ISO/TC 249

WG1 meeting

WG2 meeting

The fifth plenary meeting of ISO/TC249 was held on May 26-29 in Kyoto, hosted by the Japanese Industrial Standards Committee (JISC) and the Japanese Liaison of Oriental Medicine (JLOM). Two hundred and five delegates participated in this meeting representing twelve national member bodies, two organizations in liaison and one internal liaison. Dr. Mary Lou Pelaprat from the ISO Central Secretariat also attended this meeting. The Chair and Secretary gave reports covering the general issues arising from the business of committee during the last year. The following important issues have been discussed at the meeting: 1. Scope of the technical work of the committee 2. Introductory element for individual standard 3. The scope of ISO/TC249 4. Liaison arrangement 5. Establishment of CAG2 6. Progress on technical work which has been achieved in ISO/TC249 by 5th plenary meeting

WG3 meeting

WG4 meeting

The committee thanked Japan for its excellent hosting of the meeting. China has offered to host the next meeting in June 2015. The resolutions of the 5th plenary meeting in Kyoto (N215) can be found in ISO/TC249 e-committee at: http://isotc.iso.org/livelink/livelink?func=ll&objId=16373286&objAction=br owse&viewType=1

WG5 meeting

INFORMATION RELATED TO ISO/TC 249 TRADITIONAL CHINESE MEDICINE (PROVISIONAL)

2/9

Progress on projects ISO/CD 19465 Traditional Chinese Medicine (TCM) -- Categories of TCM Stage: 30.99

ISO/WD 18586 Traditional Chinese medicine -- Requirements for basic safety for Electroacupuncture Stimulator Stage: 20.60

ISO/AWI 19609 Traditional Chinese Medicine -- Quality and Safety of natural materials and manufacturing products made with natural materials used in and as traditional Chinese medicine (TCM) Stage: 20.00

ISO/WD 18615 Traditional Chinese medicine -General requirements of electric radial pulse tonometric devices Stage: 20.20 ISO/CD 18662-1 Traditional Chinese medicine -- Vocabulary -- Part 1: Chinese Materia Medica Stage: 30.60

ISO/AWI 19610 Traditional Chinese medicine -- Requirements for industrial manufacturing process of red ginseng Stage: 20.00

ISO/WD 18663 Traditional Chinese Medicine - Electroacupuncture stimulator device for quality Stage: 20.60

ISO/AWI 19611 Traditional Chinese medicine -- Cupping apparatus for medical use except for the traditional cupping apparatuses Stage: 20.00

ISO/DIS 18664 Traditional Chinese Medicine - Determination of heavy metals in herbal medicines used in Traditional Chinese Medicine Stage: 40.40

ISO/AWI 19614 Traditional Chinese medicine -- Pulse graph force transducer Stage: 20.00

ISO/DIS 18665 Traditional Chinese Medicine - Herbal decoction apparatus Stage: 40.00

ISO/AWI 19617 Traditional Chinese Medicine -- General requirements for manufacturing process of natural products used in and as Traditional Chinese Medicine Stage: 20.00

ISO/DIS 18666 Traditional Chinese medicine -General requirements of moxibustion devices Stage: 40.00

ISO/AWI 19824 Traditional Chinese Medicine -- Schisandra Chinensis seeds and seedlings Stage: 20.00

ISO/CD 18668-1 Traditional Chinese Medicine -- Coding System of Chinese Medicines -- Part 1: Coding Rules for Chinese Medicines Stage: 30.99

ISO/AWI 20333 Traditional Chinese Medicine -- Coding Rules for Chinese Medicines in Supply Chain Management Stage: 20.00

ISO/AWI 18668-2 Traditional Chinese medicine -- Coding System of Chinese Medicines -- Part 2: Codes of Decoction Pieces Stage: 20.00

ISO/AWI 20334 Traditional Chinese Medicine -- Coding System of Formulas Stage: 20.00

ISO/CD 18746 Traditional Chinese Medicine -Intradermal acupuncture needles Stage: 30.60


3/9

N151 Coding System of Chinese Medicines -

ISO/NP 20493 Infrared moxibustion-like

Part 3: Codes of Chinese Materia Medica

instrument

End of NP ballot: 2014-12-28


ISO/NP 20308 Gua Sha instruments

N 251 Electrical resistance detector at


Acupuncture Points End of NP ballot: 2015-02-27

N214 Coding System of Chinese Medicines Part 4: Codes of Granule Forms of

ISO/NP 20497 Facial imaging device – face

Individual Medicinals for Prescriptions

information acquisition instrument



ISO/NP 20311 Salvia miltiorrhiza seeds and

ISO/NP 20498-2 Computerised tongue image

seedlings

analysis system-Part 2: Light environment



ISO/NP 20408 Panax notoginseng seeds and

ISO/NP 20498-1 Computerised tongue image

seedlings

analysis system- Part 1: General requirements



ISO/NP 20409 Panax notoginseng root and

ISO/NP 20520 Infection control for

rhizome

acupuncture treatment



ISO/NP 20487 Test Method on Acupuncture needles for single use on electrical stimulation End of NP ballot: 2015-02-25 INFORMATION RELATED TO ISO/TC 249 TRADITIONAL CHINESE MEDICINE (PROVISIONAL)

4/9

Ballot on the inclusion of Ayurveda within ISO/TC249 At the 4th and 5th plenary meetings of

respect for the importance of Ayurveda but the

ISO/TC249, the committee explored the request

primary difficulties were the high workload of

from India to include Ayurveda into the scope of

ISO/TC 249 in the area of TCM and related TM’s

committee in great detail, it was then resolved at

and the different range of stakeholders involved

Kyoto meeting [Resolution 86 (Kyoto 2014:4)] to

with Ayurveda.

carry out a formal CIB following the meeting to finalise the matter.

It was also recognised that many general aspects of standards developed by ISO/TC 249 in areas

The secretariat launched a formal ballot on this

such as quality and safety could be relevant to the

issue on Aug 27, 2014. The CIB has been closed

standards development for Ayurveda. The

on Sep 27 and the outcome is a consensus by

committee greatly appreciates the active

members that Ayurveda should not be included

contribution of the Indian delegation to the work

within the scope of ISO/TC 249. The ISO Central

of ISO/TC 249 and encourage their future

Secretariat has been advised of this outcome. The

participation.

discussions by the committee demonstrated a high

Ballot on the form of modification of the TC249 scope ISO/TC249

In accordance with the past committee resolutions and the outcome of CIB balloting on Ayurveda, TC249 secretariat has drafted the Form “MODIFICATION OF THE TITLE AND SCOPE OF AN ISO TECHNICAL COMMITTEE” for submission to the TMB. Before the formal approval of ISO/TMB, the committee was requested to pass a resolution accepting the exact wording of the new Scope, thus the secretariat launches a one-month ballot within TC249 on Nov 15, 2014. The voting which ended on Dec 15 and its result indicates a consensus by TC249 members that the committee focuses on standardization in the field of medical systems derived from ancient Chinese medicine which shall be able to share one common set of standards. The secretariat will submit the scope form and the results of voting to TMB for approval. The Strategic Business Plan (SBP) will state the technical work areas that the committee has prioritised and which are consistent with and are carried out under the committee’s scope. These are quality and safety of natural raw materials and manufactured products and of medical devices and informatics, including service standards limited to involving the safe use and delivery of devices and medicines but not into the clinical practice or application of those products. The draft of the updated SBP will be circulated for input as soon as the TMB decision is made.


5/9

Activities within ISO/TC 249 and ISO/IEC The meetings of the Chair’s Advisory Group of ISO/TC 249 The eighth TC249/CAG meeting has been held via WebEx meeting tool on May 7th, 2014. The ninth TC249/CAG meeting has been held via WebEx meeting tool on Dec 3rd, 2014.

The fourth meeting of ISO/TC 249/WG3&WG4 The fourth meetings of ISO/TC249/WG3 & WG4 were held on February 13-14th in Sydney, Australia. Thirty-six attendees from 4 countries participated in the meetings, including the representatives from Standards Australia and TC249 Secretariat. On Feb 13th, WG3 had the discussion on expanding the scope of WG3 and participants agreed that the WG3 recommends to the ISO/TC249 that the scope of the WG be amended to the ‘Standardisation in the field of safety and quality of acupuncture’. A couple of projects have been discussed as well in the meeting. On Feb 14th, WG4 convener presented a roadmap for the harmonization of projects within the scope WG4 regarding IEC requirements and discussed several working drafts of active projects in the meeting. The revised final WDs will be sent to the secretariat for the next steps.


6/9

The joint meeting of ISO/TC215 Health Informatics and CEN/TC251 Health Informatics Working Group The joint meeting of ISO/TC215 Health Informatics and CEN/TC251 Health Informatics Working Group has been held in Berlin from Oct 6-10, 2014. Dr SANG Zhen and Ms. LI Jing (Ivy), the representatives from the TC249 secretariat attended the meeting including the TM/TF, JWG1 and WG3 sessions. Further communication with TC215 secretary, Lisa Spellman and the relevant leaders from TM/TF and JWG1 have been explored. Since this innovative mechanism of JWG1 being set up in 2012, there are totally 4 joint projects under development, of which three are from TC249 (ISO/DIS18668-1, ISO/WD18668-2 and ISO/WD20333) and the other one from TC215 (ISO/DTS18790-1). Although two more projects from TC215, respectively, ISO/NP16843-1 and ISO/DTS16843-2 were not fallen into JWG1 items for both of them were reinstated projects and well advanced, the experts saw much interest of TC249 and recommended to have a consultation process within TC249. Both projects currently are under onemonth consultation within TC249/WG5 from Dec 20, 2014-Jan 20, 2015. The secretariat of TC249 will then collate comments and submit them to TC215 secretary.

The meeting of IEC/TC 62 and its Subcommittees, Electrical Equipment in Medical Practice The meeting of IEC/TC 62 and its Subcommittees, Electrical Equipment in Medical Practice was held on 17-26 November 2014 in New Orleans, Louisiana USA. According to the resolutions made in the fifth plenary meeting of ISO/TC 249 in Kyoto this May, Dr. SANG Zhen and Ms. XU Xiaoting (Shirley) attended the plenary meeting of IEC/SC62D ELECTROMEDICAL EQUIPMENT as the representatives from ISO/TC 249 to explore the liaison relationship with IEC/SC 62D. Ms. XU made a brief introduction to the work of ISO/TC 249 at that meeting. SC 62D approved the resolution to establish the liaison with ISO/TC 249 and the secretary of SC 62D will circulate the list of projects currently underway or planned in TC 249 and 62D will be asked to either participate or comment on the documents.


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International Forum on Standardization of Traditional Chinese Medicine “International Forum on Standardization of Traditional Chinese Medicine” was organized by the secretariat of ISO/TC 249 and held on 14 December, 2014 in Shanghai, China. Thirty-eight experts including senior representatives of various pharmacopoeia organizations explored the opportunities and approaches for a coordinated approach to developing TCM standards. The secretary of ISO/TC 249, Prof Shen Yuandong welcomed all the participants and noted that it’s an ideal opportunity for exchanging information and establishing cooperation for the international development of TCM. Pharmacopoeias are a source of standards for a country or a region and are often mandated in law. Those represented at the meeting were the European Pharmacopoeia, the United States Pharmacopoeia, the Chinese Pharmacopoeia and the Thai Pharmacopoeia. Also participants provided information on the Japanese Pharmacopoeia. Presentations were also made on the work of the Good Practice in Traditional Chinese Medicine Research Association (GP-TCM Research Association). The participants then focused on specific advice to ISO/TC 249 in planning its work priorities in the herbal area for the development of international standards. The meeting also discussed the benefits of ongoing communication and coordination and planned how this might be done. All the participants thought that the meeting had been valuable and the secretary indicated that a similar meeting might be arranged in the medical device area. The meeting concluded with the participants being warmly thanked for their thoughtful contributions and an exchange of season greetings. The outcomes will be circulated to TC249 members after receiving input from all participants.


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The eighth meeting of ISO /WG2

The eighth meeting of ISO/WG2 will be held in Berlin, Germany on Feb. 12-13, 2015.

The sixth plenary meeting of ISO/TC 249 The cutoff dates for submitting papers for preparation of the 6th plenary meeting in Beijing, China on June 1-4, 2015 are: - 31 January for major documents including NWIPs to be discussed during the meeting - 15 April for other papers - 23 May for the final agenda and minor papers

◤New Year's Wish◥

TC249 secretariat would like to extend our deep gratitude and warm greetings to all the experts who invested in and supported our standard work over the past 5 years. Wishing you peace, joy and happiness through Christmas and the upcoming new year of 2015! ISO/TC249 Secretary

Shen Yuandong Dec 24, 2014

Contacts ISO/TC 249 Secretariat Address: 7-C Shuguang Building, 189 Pu' an Road, Shanghai 200021, P. R. China Email: [email protected] Tel: 0086-(0)21-53821520 Fax: 0086-(0)21-53821522 INFORMATION RELATED TO ISO/TC 249 TRADITIONAL CHINESE MEDICINE (PROVISIONAL)

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Academie voor Chinese Geneeswijze Qing-Bai

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