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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.080 Sterilization and disinfection>11.080.01 Sterilization and disinfection in general>BS EN ISO 11140-6:2022 Sterilization of health care products. Chemical indicators Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
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immediate downloadReleased: 2022-12-05
BS EN ISO 11140-6:2022 Sterilization of health care products. Chemical indicators Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

BS EN ISO 11140-6:2022

Sterilization of health care products. Chemical indicators Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers

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Standard number:BS EN ISO 11140-6:2022
Pages:52
Released:2022-12-05
ISBN:978 0 580 91087 6
Status:Standard

BS EN ISO 11140-6:2022 Sterilization of Health Care Products

Introducing the BS EN ISO 11140-6:2022, a comprehensive guide to the sterilization of health care products. This standard is a must-have for any health care facility, laboratory, or medical research center that values the highest standards of cleanliness and sterilization. It provides detailed instructions on the use of Type 2 chemical indicators and process challenge devices for performance testing of small steam sterilizers.

Key Features

The BS EN ISO 11140-6:2022 is a 52-page document, packed with essential information and guidelines. It was released on the 5th of December, 2022, ensuring that it contains the most up-to-date and relevant information. The ISBN number is 978 0 580 91087 6, making it easy to locate and order.

This standard is recognized globally, ensuring that your facility is adhering to the highest international standards of sterilization. It is a Type 2 indicator, meaning it is designed to indicate exposure to a sterilization process and to differentiate between processed and unprocessed units.

Benefits of BS EN ISO 11140-6:2022

By implementing the guidelines outlined in the BS EN ISO 11140-6:2022, you can ensure that your sterilization processes are effective and reliable. This can help to prevent the spread of infection, protect your staff and patients, and maintain the integrity of your research.

Furthermore, by adhering to this standard, you can demonstrate to regulatory bodies, clients, and patients that your facility is committed to maintaining the highest standards of cleanliness and sterilization. This can enhance your reputation and increase trust in your services.

Who Should Use BS EN ISO 11140-6:2022?

The BS EN ISO 11140-6:2022 is suitable for a wide range of health care facilities, including hospitals, clinics, dental practices, and laboratories. It is also useful for medical research centers and pharmaceutical manufacturers. Any organization that uses small steam sterilizers can benefit from the guidelines outlined in this standard.

Order Your Copy Today

Don't compromise on the safety and cleanliness of your health care facility. Order your copy of the BS EN ISO 11140-6:2022 today and ensure that your sterilization processes are up to the highest international standards.

Remember, the health and safety of your staff and patients depend on effective sterilization processes. Make sure you're doing everything you can to maintain the highest standards by implementing the guidelines outlined in the BS EN ISO 11140-6:2022.

Status: Standard

DESCRIPTION

BS EN ISO 11140-6:2022


This standard BS EN ISO 11140-6:2022 Sterilization of health care products. Chemical indicators is classified in these ICS categories:
  • 11.080.01 Sterilization and disinfection in general
This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators and biological indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers according to EN 13060. NOTE      The hollow and porous devices described in this document are not intended for use as surrogate devices for hollow and porous medical devices used in health care facilities. a)    Chemical indicators used with a porous device specified in this document are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060). This document specifies the requirements for: —    a reference porous device (RPD) as a reference device by which alternative porous indicator systems (APISs) can be shown to be equivalent in performance according to this document, i.e. a textile test pack in which steam penetration is judged by thermometric means; —    an alternative porous chemical indicator system equivalent in performance to the RPD, i.e. an APIS, usually commercially manufactured, of any design. b)    Chemical indicators used with a hollow load device specified in this document are designed to demonstrate the adequacy of steam penetration into a narrow lumen (previously known as hollow load A) in small steam sterilizers (see EN 13060). This document specifies the requirements for: —    a reference hollow device (RHD) used as a reference device in this document, i.e. a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator; —    an alternative hollow device: —    employing the same specific test load as defined for the RHD and a chemical indicator designed specifically for use in the reference hollow test load, i.e. a lumened device with an attached capsule in which steam penetration is judged by visual examination of a chemical indicator; —    equivalent in performance to the RHD, i.e. an alternative hollow device, usually commercially manufactured, of any design.
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