UNE EN ISO 11138-1:2017
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
Esterilización de productos sanitarios. Indicadores biológicos. Parte 1: Requisitos generales. (ISO 11138-1:2017).
| Standard number: | UNE EN ISO 11138-1:2017 |
| Pages: | 51 |
| Released: | 2017-11-08 |
| Status: | Standard |
| Pages (Spanish): | 56 |
UNE EN ISO 11138-1:2017
1.1 General 1.1.1 This part of ISO 11138 provides 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. 1.1.2 This part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies. NOTE National or regional regulations may apply.