BS EN ISO 17664-1:2021 - Processing of Health Care Products

Standard Number: BS EN ISO 17664-1:2021

Pages: 36

Released: 2021-09-01

ISBN: 978 0 539 15411 5

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

Status: Standard

Overview

The BS EN ISO 17664-1:2021 standard is an essential document for anyone involved in the processing of health care products, particularly those dealing with critical and semi-critical medical devices. This standard provides comprehensive guidelines and information that must be provided by the medical device manufacturer to ensure the proper processing of these devices.

Why This Standard is Crucial

In the healthcare industry, the proper processing of medical devices is paramount to ensuring patient safety and maintaining the integrity of medical procedures. The BS EN ISO 17664-1:2021 standard outlines the necessary steps and information required to achieve this, making it an indispensable resource for healthcare professionals, medical device manufacturers, and regulatory bodies.

Key Features

• Comprehensive Guidelines: The standard provides detailed instructions on the information that must be provided by the medical device manufacturer for the processing of critical and semi-critical medical devices.
• Patient Safety: By adhering to the guidelines set forth in this standard, healthcare providers can ensure that medical devices are processed correctly, thereby minimizing the risk of infection and other complications.
• Regulatory Compliance: Compliance with this standard helps medical device manufacturers meet regulatory requirements, ensuring that their products are safe and effective for use in healthcare settings.
• Industry Best Practices: The standard incorporates industry best practices, making it a valuable resource for staying up-to-date with the latest advancements and methodologies in medical device processing.

Detailed Content

The BS EN ISO 17664-1:2021 standard spans 36 pages and covers a wide range of topics related to the processing of medical devices. Some of the key areas addressed include:

• Cleaning and Disinfection: Guidelines for the effective cleaning and disinfection of medical devices to ensure they are safe for reuse.
• Sterilization: Detailed instructions on the sterilization processes that must be followed to eliminate any potential contaminants.
• Packaging and Storage: Recommendations for the proper packaging and storage of medical devices to maintain their sterility and functionality.
• Validation and Verification: Procedures for validating and verifying the effectiveness of the processing methods used.
• Documentation: Requirements for the documentation that must be provided by the medical device manufacturer to support the processing instructions.

Who Should Use This Standard?

The BS EN ISO 17664-1:2021 standard is designed for a wide range of stakeholders in the healthcare industry, including:

• Healthcare Providers: Ensuring that medical devices are processed correctly is crucial for patient safety and the success of medical procedures.
• Medical Device Manufacturers: Providing the necessary information for the proper processing of their products is essential for regulatory compliance and customer satisfaction.
• Regulatory Bodies: This standard serves as a benchmark for evaluating the safety and effectiveness of medical device processing methods.
• Quality Assurance Professionals: Ensuring that processing methods meet the highest standards of quality and safety.

Benefits of Adopting This Standard

Adopting the BS EN ISO 17664-1:2021 standard offers numerous benefits, including:

• Enhanced Patient Safety: By following the guidelines in this standard, healthcare providers can significantly reduce the risk of infections and other complications associated with improperly processed medical devices.
• Regulatory Compliance: Compliance with this standard helps medical device manufacturers meet regulatory requirements, ensuring that their products are safe and effective for use in healthcare settings.
• Improved Efficiency: The standard provides clear and concise instructions for the processing of medical devices, helping to streamline workflows and improve efficiency.
• Industry Recognition: Adhering to this internationally recognized standard demonstrates a commitment to quality and safety, enhancing the reputation of healthcare providers and medical device manufacturers.

Conclusion

The BS EN ISO 17664-1:2021 standard is an invaluable resource for anyone involved in the processing of health care products, particularly those dealing with critical and semi-critical medical devices. By providing comprehensive guidelines and information, this standard helps ensure that medical devices are processed correctly, thereby enhancing patient safety, regulatory compliance, and overall efficiency. Whether you are a healthcare provider, medical device manufacturer, regulatory body, or quality assurance professional, adopting this standard is a crucial step towards achieving the highest standards of quality and safety in medical device processing.

BS EN ISO 17664-1:2021

This standard BS EN ISO 17664-1:2021 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 critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.

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:

1. initial treatment at the point of use;

2. preparation before cleaning;

3. cleaning;

4. disinfection;

5. drying;

6. inspection and maintenance;

7. packaging;

8. sterilization;

9. storage;

10. transportation.

This document excludes processing of the following:

• non-critical medical devices unless they are intended to be sterilized;

• textile devices used in patient draping systems or surgical clothing;

• medical devices specified by the manufacturer for single use only and supplied ready for use.