BS EN ISO 17664-2:2023 - Processing of Health Care Products

Standard Number: BS EN ISO 17664-2:2023

Pages: 38

Released: 2024-01-10

ISBN: 978 0 539 26399 2

Name: Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices Non-critical medical devices

Status: Standard

Overview

Introducing the BS EN ISO 17664-2:2023, a comprehensive standard that provides essential guidelines for the processing of non-critical medical devices. This standard is a must-have for medical device manufacturers, healthcare providers, and regulatory bodies, ensuring that all non-critical medical devices are processed safely and effectively.

Why Choose BS EN ISO 17664-2:2023?

The BS EN ISO 17664-2:2023 standard is meticulously designed to offer clear and concise information that medical device manufacturers must provide for the processing of non-critical medical devices. Here are some compelling reasons to choose this standard:

• Comprehensive Guidelines: This standard covers all aspects of processing non-critical medical devices, ensuring that every step is clearly defined and easy to follow.
• Enhanced Safety: By adhering to the guidelines provided in this standard, healthcare providers can significantly reduce the risk of infection and ensure patient safety.
• Regulatory Compliance: Compliance with this standard ensures that your medical devices meet international regulatory requirements, facilitating smoother market access and acceptance.
• Up-to-Date Information: Released on 2024-01-10, this standard incorporates the latest advancements and best practices in the field of medical device processing.

Key Features

The BS EN ISO 17664-2:2023 standard is packed with features that make it an indispensable resource for anyone involved in the processing of non-critical medical devices:

• Detailed Instructions: Provides step-by-step instructions for the cleaning, disinfection, and sterilization of non-critical medical devices.
• Manufacturer's Responsibilities: Clearly outlines the information that manufacturers must provide to ensure proper processing of their devices.
• Quality Assurance: Includes guidelines for quality assurance processes to ensure that all devices are processed to the highest standards.
• Risk Management: Offers comprehensive risk management strategies to identify and mitigate potential hazards associated with the processing of non-critical medical devices.
• Compatibility Information: Provides detailed information on the compatibility of different processing methods with various materials used in non-critical medical devices.

Who Should Use This Standard?

The BS EN ISO 17664-2:2023 standard is designed for a wide range of stakeholders in the healthcare industry, including:

• Medical Device Manufacturers: Ensure that your devices are processed correctly and meet all regulatory requirements.
• Healthcare Providers: Implement best practices for the processing of non-critical medical devices to enhance patient safety and care quality.
• Regulatory Bodies: Use this standard as a benchmark for evaluating the processing practices of medical device manufacturers and healthcare providers.
• Quality Assurance Professionals: Develop and implement robust quality assurance processes based on the guidelines provided in this standard.

Benefits of Compliance

Adhering to the BS EN ISO 17664-2:2023 standard offers numerous benefits, including:

• Improved Patient Safety: By following the guidelines, healthcare providers can minimize the risk of infection and ensure the highest level of patient safety.
• Regulatory Approval: Compliance with this standard facilitates regulatory approval and market access for your medical devices.
• Enhanced Reputation: Demonstrating adherence to international standards enhances your reputation as a reliable and quality-focused organization.
• Operational Efficiency: Clear and concise guidelines streamline the processing of non-critical medical devices, improving operational efficiency.
• Risk Mitigation: Comprehensive risk management strategies help identify and mitigate potential hazards, ensuring safe and effective processing.

Conclusion

The BS EN ISO 17664-2:2023 standard is an essential resource for anyone involved in the processing of non-critical medical devices. With its comprehensive guidelines, detailed instructions, and focus on safety and quality, this standard ensures that all non-critical medical devices are processed to the highest standards. Whether you are a medical device manufacturer, healthcare provider, regulatory body, or quality assurance professional, this standard provides the information and guidance you need to ensure safe and effective processing of non-critical medical devices.

Invest in the BS EN ISO 17664-2:2023 standard today and take a significant step towards enhancing patient safety, ensuring regulatory compliance, and improving the overall quality of healthcare products.

BS EN ISO 17664-2:2023

This standard BS EN ISO 17664-2:2023 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices is classified in these ICS categories:

• 11.080.01 Sterilization and disinfection in general

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation.