Manufacturing process and Quality control
Shenzhou® Acupuncture Neeldes
Near the world metropolis of Shanghai lies the ancient city of Suzhou, the most famous location for the production of acupuncture needles in China, indeed the world. The city is renowned for its history of more than 100 years in the production of acupuncture needles by means of a unique technology.
SHENZHOU- brand acupuncture needles are manufactured in Suzhou and they have enjoyed the full confidence of practitioners all over the world. The high-quality needle is manufactured according to ISO 9000- and GMP standards by means of a process combining traditional expertise and modern technology. Shenzou needles boast the following characteristics:
- 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 full automated equipment so 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 (Englisch, Dutch, German, Italy, Spain, Portugal, Sweden, Denmark, Finland, Norway) 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.
In addition to the requirement for sterility the needle shall also be Biocompatible. 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.