BS EN ISO 11987:2012

Comprehensive Healthcare Technology Standard

BS EN ISO 11987:2012 is a critical standard for the healthcare industry, providing detailed technical specifications and requirements for the design, manufacture, and use of healthcare technology. This British Standard, identical to ISO 11987:2012, is an essential resource for healthcare providers, medical device manufacturers, and industry professionals seeking to ensure compliance, quality, and safety.

Detailed Technical Specifications

BS EN ISO 11987:2012 covers a wide range of healthcare technology, including:• Medical devices• In vitro diagnostic medical devices• Hospital equipment• Laboratory equipment• Assistive products for persons with disabilityThe standard outlines comprehensive requirements and test methods for these healthcare technologies, addressing key aspects such as:• Design and development• Materials and manufacturing• Sterilization and disinfection• Biocompatibility and toxicology• Electrical safety and electromagnetic compatibility• Software and information security• Usability and human factors• Packaging, storage, and transportationBy adhering to the specifications outlined in BS EN ISO 11987:2012, healthcare organizations and medical device manufacturers can ensure their products and services meet the highest standards of quality, safety, and performance.

Compliance and Regulatory Benefits

Compliance with BS EN ISO 11987:2012 offers numerous benefits for healthcare organizations and medical device manufacturers:• Demonstrates conformity with essential requirements and regulations, such as the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR)• Enhances product safety and reliability, reducing the risk of adverse events and liability• Facilitates market access and acceptance, as the standard is recognized globally• Improves customer confidence and trust in your healthcare technology• Streamlines the product development and certification process• Supports continuous improvement and innovation in the healthcare industry

Ensure Quality and Compliance with BS EN ISO 11987:2012

Whether you are a healthcare provider, medical device manufacturer, or industry professional, BS EN ISO 11987:2012 is an essential resource for ensuring the quality, safety, and compliance of your healthcare technology. By adhering to the detailed technical specifications and regulatory requirements outlined in this British Standard, you can demonstrate your commitment to excellence and provide your customers with the highest-quality healthcare solutions.