I.S. EN ISO 11135:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
Hardcopy , PDF
17-12-2019
English
01-01-2014
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (normative) - Determination of lethal
rate of the sterilization process - Biological
indicator/bioburden approach
Annex B (normative) - Conservative determination
of lethal rate of the sterilization process -
Overkill approach
Annex C (informative) - Temperature sensors, RH
sensors and biological indicator numbers
Annex D (informative) - Guidance on the application
of the normative requirements
Annex E (normative) - Single Lot Release
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 90/385/EEC
Annex ZB (informative) - Relationship between this
European Standard and the Essential
Requirements of Directive 93/42/EEC
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.