A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 15th Year of Publication
Page  3 of 10

Technology

Medical Device Manufacturing : Critical Issues
Plastics In Healthcare - Expanding Horizons
 
Standards and Regulations
  • International Standard ISO - 3826 : Standard for Polyvinyl Chloride Containers for Collection and Storage of Blood and Blood Components British Standard BS 2463-”Transfusion equipment for medical use”, Part 1: Specifications for collapsible containers for blood and blood components.

  • British Standard BS 5736 “Evaluation of medical devices to biological hazards

  • German Standard - DIN 58361 This standard specifies the physical, chemical and biological requirements for blood bags, the materials used in their manufacture and tests to be done.

  • ISO 13485 - Quality management systems for manufacture of Medical Devices

  • ASTM F639-98a(2003)-Standard for PE for Medical Applications

Biomedical Waste Management

Artificial Feet & Dental Treatment

  • Light weight
  • Durable
  • Resistant to breakages
  • Non-toxic
  • Body compatible

According to the Waste Rules (Ann.3 :2003) the wastes are disposed as per the following methods depending on the nature of contamination:

 

• Incineration

• Auto-clave

• Hydro-clave
 

• Microwave
• Chemical Treatment
• Mutilation -Shredding & Needle
Destroyer
• Effluent Treatment

It can be also disposed by Landfill method after getting rid of germs and chemicals. In India incineration method is widely used disposal method after the products has been sorted out.


To sum up I would like to say that Plastics have made our lives convenient, many modern Medical Devices would be impossible w/o Plastics, much of modern Medical practice would be impossible w/o Plastics and very fact that plastics have reduced contamination, relieved pain and cut medical costs.

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