I.S. EN ISO 11138-1:2017
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
Hardcopy , PDF
English
01-01-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
5 Specific manufacturing requirements
6 Determination of population and resistance
7 Culture conditions
Annex A (normative) - Determination of viable count
Annex B (normative) - Determination of growth
inhibition by carriers and primary packaging
materials exposed to sterilization processes
Annex C (normative) - D value determination by
survivor curve method
Annex D (normative) - D value determination by
fraction negative method
Annex E (normative) - Survival-kill response
characteristics
Annex F (informative) - Relationship between
components of biological indicators
Bibliography
Describes 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.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes I.S. EN 866-1. (09/2006)
|
| DocumentType |
Standard
|
| Pages |
58
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 11138-1:2015-10 (Draft) | Identical |
| NBN EN ISO 11138-1 : 2006 | Identical |
| EN ISO 11138-1:2017 | Identical |
| NS EN ISO 11138-1 : 2017 | Identical |
| ISO 11138-1:2017 | Identical |
| BS EN ISO 11138-1:2017 | Identical |
| NF EN ISO 11138-1 : 2017 | Identical |
| NEN EN ISO 11138-1 : 2017 | Identical |
| UNE-EN ISO 11138-1:2017 | Identical |
| DIN EN ISO 11138-1:2017-07 | Equivalent |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : Users cannot be edited or removed once added to your Multi user PDF.