15/30321502 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
Hardcopy , PDF
30-04-2017
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
5 Specific manufacturing requirements
6 Determination of 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
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.