Introduction
- The tip is carefully hand-polished into the “pine-leaf” shape which
allows it to penetrate the skin easily without injury to the blood
vessels, nerves or other tissue. No chemical analgesic of any kind is
added to the tip of the needle. The body of the needle is favoured
for its thickness, moderate degree of hardness, excellent flexibility
and perfectly smooth finish. The handle of the needle is so firmly
bonded that the handle can never separate from the shaft.
Extensive clinical use of Shenzhou-brand acupuncture needles
has shown that the needle is not only easy to be inserted into the
body, creating the desired needling sensations with a minimum
of pain, but very safe and applicable for any kind of manipulating
The tip is carefully hand-polished into the “pine-leaf” shape which
allows it to penetrate the skin easily without injury to the blood
vessels, nerves or other tissue. No chemical analgesic of any kind is
added to the tip of the needle. The body of the needle is favoured
for its thickness, moderate degree of hardness, excellent flexibility
and perfectly smooth finish. The handle of the needle is so firmly
bonded that the handle can never separate from the shaft.
Extensive clinical use of Shenzhou-brand acupuncture needles
has shown that the needle is not only easy to be inserted into the
The tip is carefully hand-polished into the “pine-leaf” shape which
allows it to penetrate the skin easily without injury to the blood
vessels, nerves or other tissue. No chemical analgesic of any kind is
added to the tip of the needle. The body of the needle is favoured
for its thickness, moderate degree of hardness, excellent flexibility
and perfectly smooth finish. The handle of the needle is so firmly
bonded that the handle can never separate from the shaft.
Extensive clinical use of Shenzhou-brand acupuncture needles has shown that the needle is not only easy to be inserted into the body, creating the desired needling sensations with a minimum of pain, but very safe and applicable for any kind of manipulating technique. - An indubitably strict technological manufacturing process complying to ISO 9000 requirements. Every Shenzhou needle is meticulously manufactured and undergoes a strict inspection. All needles are ultrasonically cleaned to ensure the complete removal of oils and bonded microscopic residues so that a supremely high- quality needle is achieved: smooth, clean and attractive in its appearance. The needles are packaged by fully automated equipment so as to avoid hand contamination. The needles are sterilised with ethylene oxide gas; the expiration date for using the needles is five (5) years from the date of manufacturing and sterilisation. All information on the packaging is printed in (10) languages, as required by European Union legislation (English, Dutch, German, French, Italian, Spanish, Portuguese, Swedish, Finns, Norwegian) and also in Chinees. Shenzhou-brand needles are checked by random sampling to ensure strength sharpness and sterility.
- Based on new Medical Device Directive 93/42/eeg acupuncture needles are defined as medical devices. In the current decennium the European Union has laid down essential requirements for such medical devices.
The requirement for Biocompatibility of the needle insures that there is no disadvantageous toxic effect on the human body when such a needle is used.
Biocompatibility requirements
Acupuncture needles which are usually inserted into the human skin for less than 60 min. have to comply to specific biocompatibility requirements which are defined for such devices.
For these types of products European Norms and tests are developed.
Since harmonised standards exist for cytotoxicity- tests the sponsor of the study.
(CMC) has chosen for testing random samples of the product.
Biocompatibily tests.
See Bioscan test report BSC101/1 MEM-extract, MMT test system, 24 hours incubation. dd: February 18, 1998.
See Bioscan test report BSC101/1 MEM-extract, MMT test system, 24 hours incubation. dd: February 18, 1998.
Tests were executed in an Accredited Laboratory under OECD principles of Good Laboratory Practice in January 1998. The test on these needles was executed according to EN 30993-5 page 2-6.
Test was executed in cell metabolism of fibroblasts. (see Test realization).
All test materials were sterilised before use in the test. An agreed weight of needles is put in the medium for a period of three (3) hours at 37ºC.
Results
The needles of CMC on test during this period had to comply to specific acceptance criteria. (see data sheet 1 and 2) The data sheets show that the test complies to the validation criteria set and demonstrate that there are no cytotoxic effects. See photographs: on page 8.
Conclusion
The test complies with the validation criteria set and therefore allows further processing and assessment of all other data obtained. Data obtained for the negative control will be standardised as 0% inhibition.
Test material demonstrates no cytotoxic effects and has passed the criteria.
The Acupuncture Needles of CMC passed the criteria and
are certified as being Biocompatible.