BS EN ISO 11138-4:2017
Current
The latest, up-to-date edition.
Sterilization of health care products. Biological indicators Biological indicators for dry heat sterilization processes
Hardcopy , PDF
English
30-04-2017
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/198
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| DevelopmentNote |
Supersedes BS EN 866-6 and 04/30078107 DC (08/2006) Supersedes 15/30321511 DC. (04/2017)
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| DocumentType |
Standard
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| Pages |
20
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| PublisherName |
British Standards Institution
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| Status |
Current
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| Supersedes |
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.
NOTE1 Requirements for validation and control of dry heat sterilization processes are provided by ISO20857 .
NOTE2 Requirements for work place safety can be provided by national or regional regulations.
| Standards | Relationship |
| SN EN ISO 11138-4 : 2017 | Identical |
| NBN EN ISO 11138-4 : 2006 | Identical |
| NS EN ISO 11138-4 : 2017 | Identical |
| UNI EN ISO 11138-4 : 2006 | Identical |
| UNE-EN ISO 11138-4:2017 | Identical |
| NEN EN ISO 11138-4 : 2017 | Identical |
| I.S. EN ISO 11138-4:2017 | Identical |
| DIN EN ISO 11138-4:2015-10 (Draft) | Identical |
| EN ISO 11138-4:2017 | Identical |
| ISO 11138-4:2017 | Identical |
| NF EN ISO 11138-4 : 2017 | Identical |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
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