./.WORLD TRADE
ORGANIZATIONG/TBT/Notif.00/365
15 August 2000
(00-3309)
Committee on Technical Barriers to Trade
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   JAPAN
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Ministry of Health and Welfare
Agency or authority designated to handle comments regarding the notification shall be
indicated if different from above:           
3. Notified under Article 2.9.2 [     ], 2.10.1 [ X   ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):
Syringe-type manual injector for liquids and solutions
Enteral feeding lines
Sterile infusion sets
5. Title, number of pages and language(s) of the notified document:
Standard for Syringe-Type Manual Injector for Liquids and Solutions
Standard for Fitting of Enteral Feeding LinesAmendment to the Standard of Sterile Infusion Sets (Available in English, 24 pages
including summary)
6. Description of content:   Standard for syringe-type manual injector for liquids and solutions
and Standard for fittings of enteral feeding lines will be established by Director-General's
notification.  Standard of sterile infusion sets will be amended by Director-General's
notification.  (These Standards are not mandatory but voluntary).
7. Objective and rationale, including the na ture of urgent problems where applicable:
To promote the usage of medical devices that could prevent medical accidents by the
following measures, considering the recent increase of medical accidents in Japan:
- Preventing accidents of delivering solutions for enteral feeding through infusion
lines by mistake, and of bleeding and other adverse events resulting from accidental
separation of connection of infusion lines.
- Enhancing interchangeability of devices from different manufacturers.
8. Relevant documents:
Pharmaceutical Affairs Law
Director-General's Notification No. 1079 dated 11 December 1998G/TBT/Notif.00/365
Page 2
9. Proposed date of adoption:
Proposed date of entry into force: }31 August 2000
10. Final date for comments:   25 August 2000
11. Texts available from:  National enquiry point [  X  ] or address, e-mail and telefax
number of the other body:
Evaluation and Licensing Division
Pharmaceutical and Medical Safety Bureau
Ministry of Health and WelfareTel.:  +81-3-3595-2431
Fax:  +81-3-3597-9535