Three basic characteristics of medical-grade nonwovens
(1) Biocompatibility, no product contamination.
(2) The raw material itself is non-toxic and will not cause allergies.
(3) Low bacterial content, high hydrostatic pressure, and good barrier properties.
In addition, it is also required to have a good feel, high strength, no residue, no shedding, can also be sterilized, and can withstand radioactivity, ethylene oxide and hot steam treatment. It has heat sealing (bonding) properties and is easy to composite processing.
Safety is the most important factor for medical products, and the quality of the material must be stable and reliable.
Process characteristics of medical nonwoven products
(1) It is required to be produced in a clean environment (100,000-level clean room).
(2) All operators are subject to hygiene control (wearing protective clothing, air shower, washing hands).
(3) The production process is mainly manual and carried out in an assembly line manner.
(4) There are many product specifications, and the selection of raw materials must be standardized.
(5) There are special requirements for the folding and packaging of the product for easy use.
(6) Production activities must be carried out in accordance with relevant standards, such as CE (European Conformity Assessment), TUV (German Technical Supervision Association), ISO13485 (Quality Management System for Medical Devices for Regulatory Requirements).
(7) There are strict requirements for materials and products. For example, protective products are subject to standards formulated by AAMI (American Association for the Advancement of Medical Devices), EN (European Standards Committee), NFPA (National Fire Protection Association), FDA (US Food and Drug Administration), ISO (International Organization for Standardization), GB (China National Standards) and other countries, regions and relevant organizations.