BS EN ISO 11135:2014+A1:2019 - Sterilization of Health-Care Products

Standard Number: BS EN ISO 11135:2014+A1:2019

Pages: 102

Released: January 15, 2020

ISBN: 978 0 539 12708 9

Status: Standard

Overview

The BS EN ISO 11135:2014+A1:2019 is a comprehensive standard that outlines the requirements for the development, validation, and routine control of a sterilization process for medical devices using ethylene oxide. This standard is essential for manufacturers and healthcare facilities that aim to ensure the safety and efficacy of their sterilization processes.

Why Choose BS EN ISO 11135:2014+A1:2019?

In the realm of healthcare, the sterilization of medical devices is a critical process that ensures patient safety and the effectiveness of medical treatments. Ethylene oxide is a widely used sterilizing agent due to its ability to penetrate complex medical devices and its effectiveness against a broad spectrum of microorganisms. The BS EN ISO 11135:2014+A1:2019 standard provides a detailed framework for implementing a robust sterilization process using ethylene oxide, ensuring that medical devices are free from harmful microorganisms.

Key Features

• Comprehensive Guidelines: This standard offers detailed guidelines for the entire sterilization process, from development to routine control, ensuring that all aspects are covered.
• Validation and Control: It emphasizes the importance of validation and routine control, ensuring that the sterilization process is consistently effective and reliable.
• Safety and Compliance: Adhering to this standard helps organizations comply with international safety regulations, enhancing their credibility and trustworthiness.
• Ethylene Oxide Specific: Focused specifically on ethylene oxide, this standard provides targeted guidance for using this particular sterilizing agent effectively.

Benefits of Implementing This Standard

Implementing the BS EN ISO 11135:2014+A1:2019 standard offers numerous benefits, including:

• Enhanced Patient Safety: By ensuring that medical devices are properly sterilized, healthcare providers can significantly reduce the risk of infections and complications.
• Improved Process Efficiency: The standard provides a structured approach to sterilization, helping organizations streamline their processes and improve efficiency.
• Regulatory Compliance: Compliance with this standard ensures that organizations meet international regulatory requirements, facilitating market access and reducing the risk of legal issues.
• Quality Assurance: The focus on validation and routine control ensures that the sterilization process consistently meets high-quality standards.

Who Should Use This Standard?

This standard is ideal for:

• Medical Device Manufacturers: Companies involved in the production of medical devices can use this standard to ensure their products are safely sterilized before reaching healthcare facilities.
• Healthcare Facilities: Hospitals and clinics that perform in-house sterilization can benefit from the guidelines provided in this standard to enhance their sterilization processes.
• Quality Assurance Professionals: Individuals responsible for maintaining the quality and safety of medical devices will find this standard invaluable in ensuring compliance and effectiveness.

Conclusion

The BS EN ISO 11135:2014+A1:2019 standard is an essential resource for any organization involved in the sterilization of medical devices using ethylene oxide. By providing a comprehensive framework for the development, validation, and routine control of the sterilization process, this standard helps ensure the safety and efficacy of medical devices, ultimately protecting patient health and enhancing the quality of healthcare services.

BS EN ISO 11135:2014+A1:2019

This standard BS EN ISO 11135:2014+A1:2019 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices is classified in these ICS categories:

• 11.080.01 Sterilization and disinfection in general

1.1 Inclusions

This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

NOTE 1 Among the similarities are the common need for quality systems, staff training, and proper safety measures. The major differences relate to the unique physical and organizational conditions in health care facilities, and to the initial condition of reusable medical devices being presented for sterilization.

NOTE 2 Health care facilities differ from medical device manufacturers in the physical design of processing areas, in the equipment used, and in the availability of personnel with adequate levels of training and experience. The primary function of the health care facility is to provide patient care; medical device reprocessing is just one of a myriad of activities that are performed to support that function.

NOTE 3 In terms of the initial condition of medical devices, medical device manufacturers generally sterilize large numbers of similar medical devices that have been produced from virgin material. Health care facilities, on the other hand, must handle and process both new medical devices and reusable medical devices of different descriptions and with varying levels of bioburden. They are therefore faced with the additional challenges of cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this International Standard, alternative approaches and guidance specific to health care facilities are identified as such.

NOTE 4 EO gas and its mixtures are effective sterilants that are primarily used for heat- and/or moisture-sensitive medical devices that cannot be moist heat sterilized.

NOTE 5 Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other health care products.

1.2 Exclusions

1.2.1

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

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

1.2.2

This International Standard does not detail a specified requirement for designating a medical device as sterile.

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

1.2.3

This International Standard does not specify a quality management system for the control of all stages of production of medical devices.

NOTE The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered to be elements of a quality management system. It is not a requirement of this International Standard to have a full quality management system during manufacture or reprocessing. The necessary elements 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 or reprocessing of medical devices. National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party.

1.2.4

This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.

NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations may also exist.

NOTE 2 EO is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of regulations giving safety requirements for handling EO and for premises in which it is used.

1.2.5

This International Standard does not cover sterilization by injecting EO or mixtures containing EO directly into packages or a flexible chamber.

NOTE See ISO 14937 for these types of EO processes.

1.2.6

This International Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.

NOTE 1 For further information see ISO 10993‑7 .

NOTE 2 Attention is drawn to the possible existence of national or regional regulations specifying limits for the level of EO residues present on or in medical devices.