Daily we buy things on the packaging, often see the words of the mechanical size, then this mechanical size in the end represents what it means?
Mechanical: Mechanical is the product of the national medical device production license.
Measurement of medical device standards, medical devices are directly or indirectly used in the human body instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items and must be sterile standards. Efficacy is obtained mainly by physical means, not by pharmacological, immunological or metabolic means, for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment or alleviation of injury.
Must be produced in strict accordance with the national medical device standards, without adding any hormones, antibiotics, heavy metals and other chemical agents that are likely to cause skin reactions, the product is safe and can be sold in hospitals.
Production requirements: purified workshop is required, the minimum requirement of 100,000 class
Quality system requirements: ISO9001, ISO13485 (medical device-specific)