11/30244091 DC : 0
Superseded
View Superseded by
BS EN ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Hardcopy , PDF
English
07-31-2014
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) - Release of clinical trial or
research and development product
Bibliography
BS EN ISO 11135
| Committee |
CH/198
|
| DocumentType |
Draft
|
| Pages |
87
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN ISO 11135 : DRAFT 2011 | Identical |
A newer version of this standard is available.
View Current Edition
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.