1, medical non-woven fabrics introduced
Non-woven (or non woven) is using polypropylene (pp material, the English called Non Woven) pellets as raw material, melting, spinning, shop classes, one-step continuous production from hot coiling. Due to the appearance of a cloth and some properties of the cloth called. But they are by including chemical fiber and plant fiber in water or air as the medium under the conditions of suspension or dry in the wet on the paper machine made, although not for the cloth woven by the textile so called.
Non-woven products for medical use of chemical fibers including polyester, polyamide, polytetrafluoroethylene (PTFE), polypropylene, carbon fiber and glass fiber made of medical textiles. Including disposable masks, protective clothing, gowns, isolation gowns, lab coats, nurse cap, surgical cap, doctor cap, surgical pack, mothers bags, first aid kits, diapers, pillow cases, bed sheets, quilt cover, shoe covers and other disposable medical supplies series. With the traditional cotton weaving medical textiles, medical non-woven fabrics of the bacteria, dust filtration high, low rate of surgical infection, disinfection and sterilization convenient, easy and other characteristics of composite materials. Medical non-woven products as disposable one-time items, not only ease of use, safety and health, but also effective in preventing bacterial infections, and iatrogenic cross-infection.
2, medical non-woven category
Medical non-woven fabrics are medical devices, in accordance with the Medical Devices Directive MDD 93/42/EEC, medical non-woven fabrics are mostly Class I medical devices.
3, CE certified reference standards for medical non-woven fabrics
MDD 93/42/EEC 1993 Medical Device Product Safety Directive
EN ISO 10993 Biological evaluation of medical devices (medical devices, biological assessment)
EN 980-2003 Graphical symbols for use in the labelling of medical devices (medical device labels with graphic symbols)
EN ISO 14971-2007 Medical devices - Application of risk management to medical devices (medical devices. Medical device risk management applications)
EN 1041-1998 Information supplied by the manufacturer with medical devices (manufacturers of medical equipment information) surgical gown
4, authentication mode and the list of technical documents
Annex (technical documentation + + warning system, a statement of compliance mode) non woven SMS fabric
The model for the self-declared major products (I kind of non-sterile and non-measurement products), in this mode, the manufacturer just to prepare a set of products will help assess the technical requirements meet the MDD directive documents, taking into account and the nature of the product and the risk, manufacturers should establish a system program (warning system) and keep updated, in order to assess the stage after production from the instrument acquired experience and to take disposable face masks appropriate means to implement corrective measures. Manufacturers that following the accident, the obligation to immediately inform the competent authorities: nonwoven shopping bags
- Due to equipment failure or characteristics or performance degradation, and the label or used improperly, which may result or has resulted in the death of patients or users or serious damage to health;car cover, adult diaper
- As with the device characteristics or performance of any technical or medical reasons, led to the manufacturer for the above reasons, the system to recover such equipment. nonwoven fabrics manufacturers
Finally manufacturers simply declare a statement of conformity assessment of products conform to established procedures, the model requires the following list of technical documents:
a. Description b. the manufacturer and the basic requirements of risk analysis checklist c. d. e. a full description of product test reports and, where appropriate, product-related clinical data f. list of criteria for product labeling and packaging requirements g. h . Product specifications i.EC Declaration of Conformity

Adapted from Zend Non-wovens Co., LTD : www.non-wovens.com