BS EN ISO 11137-1:2015+A2:2019 - Sterilization of Health Care Products

Ensure the highest standards of safety and efficacy in the sterilization of medical devices with the comprehensive guidelines provided by the BS EN ISO 11137-1:2015+A2:2019 standard. This essential document outlines the radiation requirements necessary for the development, validation, and routine control of sterilization processes, ensuring that healthcare products meet stringent safety criteria.

Overview

The BS EN ISO 11137-1:2015+A2:2019 standard is a critical resource for professionals involved in the sterilization of healthcare products. Released on November 27, 2019, this document provides a detailed framework for the application of radiation sterilization methods, ensuring that medical devices are free from harmful microorganisms. With 62 pages of in-depth information, this standard is an indispensable tool for maintaining compliance with international sterilization requirements.

Key Features

• Standard Number: BS EN ISO 11137-1:2015+A2:2019
• Pages: 62
• Release Date: November 27, 2019
• ISBN: 978 0 580 99289 6
• Status: Standard

Comprehensive Guidelines

This standard provides a thorough set of guidelines for the sterilization of healthcare products using radiation. It covers all aspects of the sterilization process, from initial development and validation to routine control, ensuring that every step is meticulously documented and controlled. By adhering to these guidelines, manufacturers can guarantee that their products meet the highest safety standards, protecting both patients and healthcare professionals.

Why Choose BS EN ISO 11137-1:2015+A2:2019?

Choosing the BS EN ISO 11137-1:2015+A2:2019 standard means choosing a commitment to quality and safety. This document is recognized globally as a benchmark for radiation sterilization processes, providing a reliable framework for ensuring that medical devices are sterile and safe for use. By implementing the guidelines outlined in this standard, organizations can demonstrate their dedication to maintaining the highest levels of product safety and efficacy.

Applications

The BS EN ISO 11137-1:2015+A2:2019 standard is applicable to a wide range of healthcare products, including:

• Medical devices
• Surgical instruments
• Pharmaceutical products
• Laboratory equipment

By following the radiation sterilization requirements outlined in this standard, manufacturers can ensure that their products are safe for use in a variety of healthcare settings, from hospitals and clinics to research laboratories.

Benefits of Compliance

Compliance with the BS EN ISO 11137-1:2015+A2:2019 standard offers numerous benefits, including:

• Enhanced Safety: Ensures that healthcare products are free from harmful microorganisms, reducing the risk of infection and contamination.
• Regulatory Compliance: Meets international standards for sterilization, facilitating market access and regulatory approval.
• Quality Assurance: Provides a robust framework for maintaining consistent product quality and safety.
• Reputation Management: Demonstrates a commitment to safety and quality, enhancing brand reputation and customer trust.

Conclusion

The BS EN ISO 11137-1:2015+A2:2019 standard is an essential resource for any organization involved in the sterilization of healthcare products. By providing comprehensive guidelines for radiation sterilization processes, this document ensures that medical devices meet the highest safety and quality standards. Whether you are a manufacturer, a healthcare provider, or a regulatory body, this standard is an invaluable tool for ensuring the safety and efficacy of healthcare products.

BS EN ISO 11137-1:2015+A2:2019

This standard BS EN ISO 11137-1:2015+A2:2019 Sterilization of health care products. Radiation is classified in these ICS categories:

• 11.080.01 Sterilization and disinfection in general

1.1

This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

This part of ISO 11137 covers radiation processes employing irradiators using,

1. the radionuclide⁶⁰Co or¹³⁷Cs,

2. a beam from an electron generator

   or

3. a beam from an X-ray generator.

1.2

This part of ISO 11137 does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

NOTE See, for example, ISO 22442‑1 , ISO 22442‑2 and ISO 22442‑3 .

1.2.1

This part of ISO 11137 does not detail specified requirements for designating a medical device as sterile.

NOTE Attention is drawn to regional and national requirements for designating medical devices as “sterile.” See, for example, EN 556‑1 or ANSI/AAMI ST67 .

1.2.2

This part of ISO 11137 does not specify a quality management system for the control of all stages of production of medical devices.

NOTE It is not a requirement of this part of ISO 11137 to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485 ) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party.

1.2.3

This part of ISO 11137 does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.

1.2.4

This part of ISO 11137 does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.

NOTE Attention is also drawn to the existence, in some countries, of regulations laying down safety requirements for occupational safety related to radiation.

1.2.5

This part of ISO 11137 does not specify requirements for the sterilization of used or reprocessed devices.