Medical Elastomer Standards
All elastomers used in the Medical Industry must meet the following standards:
ISO 10993
The Food and Drug Administration (FDA) requires that all sterile and non-sterile medical devices that come into direct or indirect contact with the human body meet the guidelines set out in ISO 10933. ISO 10993 contains a series of standards for evaluating the biocompatibility of medical devices.
USP Class VI (USP part 8)
The U.S. Pharmacopeial Convention (USP) standards define a protocol for evaluation of plastics and elastomeric materials for potential use in drug packaging components. The protocol defines animal testing of extracts of a control and test materials in five parts: (1) in saline, (3) in vegetable oil, (3) in alcohol, and (4) in polyethylene glycol, and (5) in rabbit intramuscular implantation of at least 5 days in duration. Test material must elicit a response less than or equal to the control.
USP Class VI testing is widely used and accepted in the USA in the healthcare industry. However, it does not meet the requirements of the ISO 10993-1 guidelines, which is what the FDA currently uses for medical device approval.
Good Manufacturing Procedures (GMP) Standards
The Food and Drug Administration (FDA), the World Health Organization (WHO), the European Union, and many other countries have established GMP guidelines for the manufacture of medical products and equipment. GMP ensures that medical products and equipment are safe for human consumption and use by defining manufacturing, testing, and quality assurance guidelines. Most countries have legislated that GMP guidelines be created, and that pharmaceutical and medical device manufacturers follow GMP procedures. Basic GMP guidelines include:
- Hygiene standards
- Control of environmental conditions
- Control of manufacturing processes
- Establishing a distribution system which minimizes risks to the quality of the products
- Complete record-keeping of all manufacturing processes and distribution channels
- Training of medical workers with respect to manufacturing processes and record-keeping
- Establishment of a system for comprehensive batch recall
For the United States, GMP guidelines require that Quality Systems Regulation (Code of Federal Regulations (CFR) Title 21 Part 820) are implemented. These regulations are enforced by the FDA. Equivalent international regulations include the EU’s Medical Devices Directive 93/42/EEC, or the International Organization for Standard’s ISO 13485.
Clean Room Standards
Clean Rooms are a closed environment used for manufacturing or scientific research with a controlled level of environmental contamination such as dust, airborne microorganisms, and chemical vapors, and aerosol particles. Clean Rooms are classified by the allowable number of particles that can be present per volume of air in the clean room environment. Applicable standards are ISO 14644 or US FED STD 209.