BS EN 14348:2005
Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants. Test methods and requirements (phase 2, step 1)
Standard number: | BS EN 14348:2005 |
Pages: | 40 |
Released: | 2005-02-09 |
ISBN: | 0 580 45419 3 |
Status: | Standard |
BS EN 14348:2005 - Chemical Disinfectants and Antiseptics
In the ever-evolving world of medical safety and hygiene, the BS EN 14348:2005 standard stands as a cornerstone for ensuring the efficacy of chemical disinfectants and antiseptics. This comprehensive standard provides a rigorous framework for evaluating the mycobactericidal activity of chemical disinfectants, particularly in medical settings where the highest levels of hygiene are paramount.
Overview of BS EN 14348:2005
Released on February 9, 2005, the BS EN 14348:2005 standard is a critical document for professionals in the medical and healthcare industries. It outlines the quantitative suspension test used to assess the mycobactericidal activity of chemical disinfectants, including those used for disinfecting medical instruments. This standard is part of a series of tests and requirements, specifically identified as phase 2, step 1, which are essential for ensuring that disinfectants meet the necessary safety and efficacy criteria.
Key Features and Benefits
- Comprehensive Testing Methodology: The standard provides detailed test methods that are essential for evaluating the effectiveness of disinfectants against mycobacteria, which are known for their resistance to many common disinfectants.
- Ensures High Standards of Hygiene: By adhering to this standard, healthcare facilities can ensure that their disinfectants are capable of eliminating harmful mycobacteria, thereby maintaining a safe and sterile environment for patients and staff.
- Applicable to a Wide Range of Disinfectants: The standard is applicable to various chemical disinfectants, including those used for instrument disinfection, making it versatile and widely applicable in the medical field.
- International Recognition: As a part of the EN standards, BS EN 14348:2005 is recognized internationally, facilitating compliance and standardization across borders.
Technical Specifications
The BS EN 14348:2005 standard is a 40-page document, identified by the ISBN 0 580 45419 3. It is a recognized standard, ensuring that it meets the rigorous criteria set forth by industry experts and regulatory bodies.
Why Choose BS EN 14348:2005?
In the medical field, where the stakes are incredibly high, ensuring the efficacy of disinfectants is not just a matter of compliance but a critical component of patient safety. The BS EN 14348:2005 standard provides a reliable and scientifically validated method for testing disinfectants, ensuring that they are capable of effectively eliminating mycobacteria, which are notoriously difficult to eradicate.
By implementing this standard, healthcare facilities can demonstrate their commitment to maintaining the highest standards of hygiene and safety. This not only protects patients and staff but also enhances the facility's reputation as a leader in healthcare excellence.
Who Should Use This Standard?
The BS EN 14348:2005 standard is essential for:
- Healthcare Facilities: Hospitals, clinics, and other medical institutions that require stringent disinfection protocols.
- Manufacturers of Disinfectants: Companies that produce chemical disinfectants and antiseptics for the medical industry.
- Regulatory Bodies: Organizations responsible for setting and enforcing hygiene and safety standards in healthcare settings.
- Research and Development Teams: Professionals involved in the development and testing of new disinfectant products.
Conclusion
The BS EN 14348:2005 standard is an indispensable tool for ensuring the effectiveness of chemical disinfectants in the medical field. By providing a detailed and scientifically validated testing methodology, it helps healthcare facilities maintain the highest standards of hygiene and safety. Whether you are a healthcare provider, a manufacturer, or a regulatory body, this standard is essential for ensuring that your disinfectants are up to the task of protecting patients and staff from harmful mycobacteria.
Invest in the BS EN 14348:2005 standard today and take a significant step towards ensuring the safety and well-being of everyone in your healthcare facility.
BS EN 14348:2005
This standard BS EN 14348:2005 Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants. Test methods and requirements (phase 2, step 1) is classified in these ICS categories:
- 11.080.20 Disinfectants and antiseptics
This document specifies a test method and the minimum requirements for mycobactericidal (or tuberculocidal) activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water — or in the case of ready-to-use products — with water. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.
This document applies to products that are used in the medical area including those that are covered by the EEC/93/42 Directive on Medical Devices.
This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
in hospitals, in community medical facilities and in dental institutions;
in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2, step 1 test (see Annex E).
Dentistry. Materials used for dental equipment surfaces. Determination of resistance to chemical disinfectants
Biological evaluation of medical devices Evaluation and testing within a risk management process
Biological evaluation of medical devices Tests for skin sensitization
Biological evaluation of medical devices Tests for irritation