BS EN ISO 8536-10:2015

Introducing BS EN ISO 8536-10:2015

BS EN ISO 8536-10:2015 is a critical healthcare technology standard that outlines the requirements and test methods for infusion equipment used in medical practice. This British Standard, which is identical to the International Standard ISO 8536-10:2015, provides essential guidance for the design, manufacture, and performance of infusion equipment to ensure patient safety and optimal clinical outcomes.

Key Features and Benefits

Comprehensive Infusion Equipment Specifications

• Detailed requirements for the design, construction, and performance of infusion equipment, including volumetric infusion pumps, syringe pumps, and gravity-fed infusion systems.
• Specifies essential safety and quality parameters such as flow rate accuracy, occlusion detection, and air-in-line detection.
• Ensures infusion equipment meets the highest standards of reliability, durability, and user-friendliness.

Compliance and Regulatory Alignment

• Aligns with the essential requirements of the EU Medical Devices Regulation (MDR) 2017/745, helping manufacturers demonstrate compliance.
• Supports the implementation of quality management systems in accordance with ISO 13485 for medical devices.
• Facilitates the CE marking process for infusion equipment, enabling market access within the European Economic Area.

Patient Safety and Clinical Effectiveness

• Ensures infusion equipment is designed and manufactured to minimize the risk of patient harm, such as medication errors or adverse events.
• Promotes the consistent and reliable delivery of infusion therapies, contributing to improved patient outcomes.
• Provides a framework for the validation and verification of infusion equipment performance, giving healthcare providers confidence in the products they use.

Who Should Use BS EN ISO 8536-10:2015?

This British Standard is an essential reference for a wide range of stakeholders in the healthcare industry, including:

• Manufacturers of infusion equipment, such as volumetric pumps, syringe pumps, and gravity-fed systems
• Designers and engineers responsible for the development of infusion devices
• Quality assurance and regulatory affairs professionals in the medical device industry
• Healthcare providers, such as hospitals, clinics, and nursing homes, that use infusion equipment in patient care
• Regulatory authorities and notified bodies involved in the approval and certification of medical devices

Obtain Your Copy of BS EN ISO 8536-10:2015

To ensure your organization's infusion equipment meets the highest standards of quality and safety, order your copy of BS EN ISO 8536-10:2015 today. This essential British Standard is available in both digital and hardcopy formats, providing you with the resources you need to stay compliant and deliver the best possible patient care.