CSA ISO 11137 : 1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
01-10-2008
French
01-01-2003
1 Scope
2 Normative references
3 Definitions
4 Documentation
5 Personnel
6 Sterilization process validation
6.1 General
6.2 Product qualification
6.3 Installation qualification
6.4 Process qualification
6.5 Certification
6.6 Maintenance of validation
7 Routine process control
7.1 process specification
7.2 Product handling
7.3 Routine and preventive maintenance
7.4 Product irradiation
7.5 Process documentation
7.6 Sterilization acceptance
8 Management and control
Annexes
A Device and packaging materials qualification
B Dose setting methods for radiation sterilization
C Dosimeters, dosimetry and associated equipment
D Bibliography
Important note : All end users must be registered with an Account prior to user licenses being assigned.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.