To choose suitable and safe resin for different medical parts, it is very important. First of all, you should choose the safe resin for medical plastic part application. Sure you should also consider reasonable resin based safe medical application.
To choose material for plastic parts, if you have experience to choose resin for electronics, automotive and the other industrial, it is also useful. But it is not enough. The most important thing is to choose safe resin for medical parts based on the application. Otherwise, it is easy to cause medical malpractice or product is not suitable for medical application etc. Below we understand how FDA divide the medical application.
Medical equipment is classified according to the risks related to equipment application refer to FDA. The equipment is divided into class I, class II or class III, in which class I risk is low and class III risk is high.
1. Class I – these devices are unlikely to cause harm to users. Examples include enemas and elastic bandages. 35% of medical devices belong to class I, of which 93% are exempt from pre-market review.
2. Class II – these devices usually pose a moderate risk of injury to users. 53% of the device types are class II, most of which require FDA review through pre marketing notification (510 (k)).
3. Class III – these are devices that maintain or support life, implant or have potential high risk or injury. Examples of class III devices include implantable pacemakers and breast implants. 9% of the devices are class III and need to be reviewed by FDA through pre-market approval (PMA) or humanitarian device exemption (HDE).
Except above, it is also not enough to choose the medical resin. Please kindly review to see how we work hard to support you.
To choose the safe and reasonable resin, the experience is very important. We work with more than hundreds of medical plastic products production for China and oversea customers. Also we work together with resin supplier closely. To choose correct resin for medical plastic parts, generally we should consider below:
- Understand the medical plastic application first.
- Understand the medical parts contact people or not. If it is contact, then where it is contact. It is permanent implantation and temporary intervention(how long it is)
- If it is IVD or experimental supplies, you should understand which liquid or material your plastic parts will contain and how long it is.
- Medical plastic working temperature and strength will also need be consider.
- Sterilization solution also affect the resin selection. Example, if it is steam sterilization,you need high temperature resin.
you need high temperature resin.