BS EN ISO 10993-17:2023
Biological evaluation of medical devices Toxicological risk assessment of medical device constituents
| Standard number: | BS EN ISO 10993-17:2023 |
| Pages: | 80 |
| Released: | 2023-11-23 |
| ISBN: | 978 0 539 01332 0 |
| Status: | Standard |
BS EN ISO 10993-17:2023 - Biological Evaluation of Medical Devices: Toxicological Risk Assessment of Medical Device Constituents
Introducing the latest standard in the field of medical device safety and evaluation - BS EN ISO 10993-17:2023. This comprehensive document is an essential resource for professionals involved in the design, development, and regulatory compliance of medical devices. It provides a detailed framework for the toxicological risk assessment of medical device constituents, ensuring that all materials used in medical devices are safe for human use.
Key Features and Benefits
- Standard Number: BS EN ISO 10993-17:2023
- Pages: 80
- Released: 2023-11-23
- ISBN: 978 0 539 01332 0
- Name: Biological Evaluation of Medical Devices: Toxicological Risk Assessment of Medical Device Constituents
- Status: Standard
Comprehensive Coverage
This 80-page standard is meticulously crafted to cover all aspects of toxicological risk assessment. It provides a structured approach to identifying and evaluating the potential toxicological risks associated with the materials used in medical devices. The document is designed to help manufacturers and regulatory bodies ensure that medical devices are safe for their intended use.
Up-to-Date Information
Released on November 23, 2023, this standard reflects the latest advancements and regulatory requirements in the field of medical device safety. It incorporates the most recent scientific data and methodologies, making it a reliable and up-to-date resource for professionals in the industry.
Internationally Recognized
As part of the ISO 10993 series, this standard is recognized and respected worldwide. It aligns with international best practices and regulatory requirements, making it an invaluable resource for companies operating in global markets. Compliance with this standard can facilitate market access and regulatory approval in multiple jurisdictions.
Detailed Guidance
The standard provides detailed guidance on the following key areas:
- Identification of potential toxicological hazards
- Assessment of exposure levels
- Evaluation of toxicological data
- Risk characterization and management
- Documentation and reporting requirements
Each section is designed to provide clear and actionable information, helping professionals navigate the complex process of toxicological risk assessment with confidence.
Essential for Compliance
Compliance with BS EN ISO 10993-17:2023 is crucial for ensuring the safety and efficacy of medical devices. This standard helps manufacturers meet regulatory requirements and avoid costly delays or rejections during the approval process. By following the guidelines outlined in this document, companies can demonstrate their commitment to safety and quality, building trust with regulators, healthcare professionals, and patients.
Who Should Use This Standard?
This standard is an essential resource for a wide range of professionals, including:
- Medical device manufacturers
- Regulatory affairs specialists
- Toxicologists
- Quality assurance professionals
- Research and development teams
Whether you are involved in the design, development, testing, or regulatory approval of medical devices, BS EN ISO 10993-17:2023 provides the information and guidance you need to ensure the safety and compliance of your products.
Why Choose BS EN ISO 10993-17:2023?
There are several reasons why this standard is a must-have for professionals in the medical device industry:
- Comprehensive and Detailed: Covers all aspects of toxicological risk assessment in a clear and structured manner.
- Up-to-Date: Reflects the latest scientific data and regulatory requirements.
- Internationally Recognized: Aligns with global best practices and facilitates market access.
- Essential for Compliance: Helps manufacturers meet regulatory requirements and avoid costly delays.
- Trusted Resource: Developed by experts in the field and widely respected in the industry.
Invest in Safety and Compliance
Ensuring the safety and compliance of medical devices is a critical responsibility. By investing in BS EN ISO 10993-17:2023, you are equipping yourself with the knowledge and tools needed to perform thorough and effective toxicological risk assessments. This standard is an invaluable resource that can help you navigate the complex regulatory landscape and bring safe, effective medical devices to market.
Don't compromise on safety. Make BS EN ISO 10993-17:2023 a cornerstone of your toxicological risk assessment process and ensure that your medical devices meet the highest standards of safety and quality.
Order your copy of BS EN ISO 10993-17:2023 today and take the first step towards ensuring the safety and compliance of your medical devices.
BS EN ISO 10993-17:2023
This standard BS EN ISO 10993-17:2023 Biological evaluation of medical devices is classified in these ICS categories:
- 11.100.20 Biological evaluation of medical devices
Biological evaluation of medical devices Sample preparation and reference materials
Biological evaluation of medical devices Chemical characterization of medical device materials within a risk management process
Biological evaluation of medical devices Tests for irritation