PRICES include / exclude VAT
Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.080 Sterilization and disinfection>11.080.01 Sterilization and disinfection in general>BS EN ISO 11138-1:2017 Sterilization of health care products. Biological indicators General requirements
Sponsored link
immediate downloadReleased: 2017-04-30
BS EN ISO 11138-1:2017 Sterilization of health care products. Biological indicators General requirements

BS EN ISO 11138-1:2017

Sterilization of health care products. Biological indicators General requirements

Format
Availability
Price and currency
English Secure PDF
Immediate download
335.71 USD
English Hardcopy
In stock
335.71 USD
Standard number:BS EN ISO 11138-1:2017
Pages:52
Released:2017-04-30
ISBN:978 0 580 89831 0
Status:Standard
DESCRIPTION

BS EN ISO 11138-1:2017


This standard BS EN ISO 11138-1:2017 Sterilization of health care products. Biological indicators is classified in these ICS categories:
  • 11.080.01 Sterilization and disinfection in general
  • 11.080.20 Disinfectants and antiseptics

This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.

This document specifies basic and common requirements that are applicable to all parts of ISO 11138 . Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138 . If no specific subsequent part is provided, this document applies.

NOTE National or regional regulations can apply.

This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.