ISO 8871-3:2003
Explore ISO 8871-3:2003, a vital standard for silicone elastomers in medical devices, ensuring safety, compliance, and quality in healthcare technology.
Overview of ISO 8871-3:2003
ISO 8871-3:2003 is a crucial standard within the healthcare technology sector, focusing on the characteristics of silicone elastomeric materials used in medical devices. This standard is pivotal for manufacturers and developers involved in creating safe and effective healthcare products.
Key Specifications
- Document Number: ISO 8871-3:2003
- Publication Date: August 1, 2003
- Format: PDF and Hardcopy
- Field: Health Care Technology
- Price: £46.00
Importance of ISO 8871-3:2003
This standard provides guidelines on the testing and measurement of silicone elastomers in medical applications. It is essential for ensuring the reliability and safety of medical devices by addressing the following aspects:
- Material Compliance: Ensures materials meet the necessary health and safety requirements.
- Performance Analysis: Delivers criteria for evaluating the physical and chemical properties of elastomers.
- Design Quality: Enhances the degree of usability and efficiency in medical devices.
Applications of ISO 8871-3:2003
ISO 8871-3:2003 is applied across various industries within healthcare technology, including but not limited to:
- Medical Device Manufacturing: Used in the development of devices that require silicone elastomer components.
- Quality Assurance: Provides a framework for quality control processes within manufacturing environments.
- Regulatory Compliance: Assists in meeting international regulations and standards, facilitating market access.
Conclusion
Adopting ISO 8871-3:2003 not only bolsters the credibility and reliability of medical products but also supports innovative practices in healthcare technology. Investing in this standard is essential for those engaged in advancing the safety and efficacy of medical devices.
Technical Information
Specification Details
- Elastomeric parts for parenterals and for devices for pharmaceutical use - Determination of released-particle count