SS-EN-ISO-11138-4 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)

SS-EN-ISO-11138-4 - 2017 EDITION - CURRENT
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This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

To find similar documents by classification:

11.080 (Sterilization and disinfection)

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

11.080.20 (Disinfectants and antiseptics Chemicals for industrial and domestic disinfection purposes, see 71.100.35)


Medical devices

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Designation Name

SS-EN ISO 11138-4:2017

Revision Level

2017 EDITION

Status

Current

Publication Date

April 5, 2017

Language(s)

English

Page Count

24

International Equivalent

EN ISO 11138-4:2017(IDT); ISO/WD 11138-4(IDT)