ISO/FDIS 6559

Traditional Chinese medicine — Sterile three-edge needle for single use

Médecine traditionnelle chinoise — Aiguille stérile à trois bords à usage unique

General Information

• Status: Not Published
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 16-Apr-2024
• Completion Date: 16-Apr-2024

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/FDIS 6559
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Sterile three-edge needle for single
Voting begins on:
use
2024-04-16
Médecine traditionnelle chinoise — Aiguille stérile à trois bords à
Voting terminates on:
usage unique
2024-06-11
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 6559:2024(en) © ISO 2024

---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 6559:2024(en)
International
Standard
ISO/FDIS 6559
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Sterile three-edge needle for
Voting begins on:
single use
Médecine traditionnelle chinoise — Aiguille stérile à trois bords à
Voting terminates on:
usage unique
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 6559:2024(en) © ISO 2024

© ISO 2024 – All rights reserved
ii

---------------------- Page: 2 ----------------------
ISO/FDIS 6559:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Specifications . 2
4.1 Configuration .2
4.2 Dimensions and parameters .3
4.2.1 Whole length of the three-edge needle .3
4.2.2 Length of the head of the three-edge needle.3
4.2.3 External diameter of the widest part of the head of the three-edge needle .3
4.2.4 External diameter of the body of the three-edge needle .3
4.3 Material .
...

ISO/DISFDIS 6559:2023(E)
ISO/TC 249
Secretariat: SAC
Date: 2023-07-172024-03-28
Traditional Chinese medicine — Sterile three-edge needle for single
use
Médecine traditionnelle chinoise — Aiguille stérile à trois bords à usage unique
FDIS stage

---------------------- Page: 1 ----------------------
ISO/DISFDIS 6559:2023(E2024(en)
© ISO 20232024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Fax: [phone]
EmailE-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2023 – All rights reserved
© ISO 2024 – All rights reserved
ii

---------------------- Page: 2 ----------------------
ISO/DISFDIS 6559:2023(E2024(en)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Specifications . 2
4.1 Configuration . 2
4.2 Dimensions and parameters . 3
4.2.1 Whole length of the three-edge needle . 3
4.2.2 Length of the head of the three-edge needle . 3
4.2.3 External diameter of the widest part of the head of the three-edge needle . 4
4.2.4 External diameter of the body of the three-edge needle . 4
4.3 Material . 4
5 Requirements . 4
5.1 Hardness . 4
5.2 Roughness . 4
5.3 Puncture force . 5
5.4 Corrosion resistance . 5
5.5 Sterility assurance . 5
5.6 Biological compatibility . 5
5.7 Appearance quality . 5
6 Packaging . 5
6.1 Primary package . 5
6.2 Secondary package .
...