The ISO 10555 Series on Sterile and Single-use Intravascular Catheters has recently been updated and the new second editions are available in paper and pdf format from Document Center Inc. now. The updates have been made to Parts 1, 3, 4, and 5. Part 1 states that it is replacing Part 2, which has been withdrawn. However, Part 2 is still showing as current in the ISO catalog…
Here is information on each of the new parts:
- ISO 10555-1:2013, Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
- ISO 10555-3:2013, Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
- ISO 10555-4:2013, Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
- ISO 10555-5:2013, Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters
There is also a new ISO 10555-6, “Intravascular catheters — Sterile and single-use catheters — Part 6: Subcutaneous implanted ports,” that is currently a draft document. There is no expected release date at this time.
Each of these second editions cancels and replaces the previous first editions, including all amendments if released. They are technical revisions, which means the technical content has been revised.
The most noticeable change to the documents is that Part 1 now contains much of the information that was previously specified in Parts 2, 3, 4 and 5. Additionally, the new second edition of Part 1 has 8 Informative Annexes where the first edition only had 4.
These Annexes for Part 1 now are:
- Annex A, Test method for corrosion resistance
- Annex B, Method for determining peak tensile force
- Annex C, Method for liquid leakage under pressure
- Annex D, Test method for air leakage into hub assembly during aspiration
- Annex E, Determination of flowrate through catheter
- Annex F, Test for burst pressure under static conditions
- Annex G, power injection test for flowrate and device pressure, and
- Annex H (informative only), Units of measurement systems other than those specified in this part of ISO 10555 which can additionally be used.
All ISO standards may be purchased at the Document Center webstore, www.document-center.com. Or you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Territorial restrictions may apply.
We can expect that the European adoptions of this ISO 10555 series will soon be updated as well. Should you prefer these EN editions, please let us know.
Author’s Note:
ISO 10555-1 2013 Edition has just been released as a Corrected 2nd Edition dated 7/1/2013! This new corrected reprint incorporates an editorial change in section H.2. Please get in touch for clarification if you need more information.
Thanks! Claudia Bach
