BS EN ISO 15912:2016

Comprehensive Healthcare Technology Standard

BS EN ISO 15912:2016 is the essential standard for healthcare technology professionals. This international standard, identical to ISO 15912:2016, provides detailed requirements and guidance for the design, development, and evaluation of medical devices and equipment.

Key Features and Benefits:

- Ensures safety, performance, and reliability of healthcare technology- Supports compliance with relevant regulations and directives- Promotes best practices in product development and manufacturing- Applicable to a wide range of medical devices, from simple instruments to complex systems- Covers the entire product lifecycle, from initial concept to final decommissioning- Helps manufacturers, suppliers, and healthcare providers meet industry standards

Comprehensive Guidance for Healthcare Technology

BS EN ISO 15912:2016 is a comprehensive standard that addresses all aspects of healthcare technology, including:

Design and Development

- Requirements for product design, including risk management, usability, and reliability- Guidance on software development and integration- Considerations for materials, manufacturing processes, and sterilization

Testing and Evaluation

- Procedures for product testing and validation- Methods for assessing safety, performance, and compatibility- Guidance on clinical evaluation and post-market surveillance

Regulatory Compliance

- Alignment with relevant medical device directives and regulations- Support for CE marking and other conformity assessments- Assistance in navigating the complex regulatory landscape

Ensure Compliance and Best Practices

By implementing the requirements and recommendations of BS EN ISO 15912:2016, healthcare technology professionals can:- Enhance the safety and efficacy of medical devices and equipment- Improve product quality and reliability- Streamline the development and approval process- Demonstrate compliance with industry standards and regulations- Strengthen customer confidence and trust in their products

Obtain the Standard

BS EN ISO 15912:2016 is available in both digital and hardcopy formats. The standard can be downloaded as a PDF or purchased as a physical copy, ensuring easy access to the comprehensive guidance it provides.