S.R. CEN ISO TS 17665-2:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
Hardcopy , PDF
English
01-01-2009
09-05-2024
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Material effects
5.4 Environmental considerations
6 Process and equipment characterization
6.1 Process
6.2 Equipment
7 Product definition
8 Process definition
9 Validation
9.1 General
9.2 Installation qualification (IQ)
9.3 Operational qualification (OQ)
9.4 Performance qualification (PQ)
9.5 Review and approval of the validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 Demonstration of continued effectiveness
12.2 Recalibration
12.3 Maintenance of equipment
12.4 Requalification
12.5 Assessment of change
Annex A (informative) - Evaluation of a sterilization process
primarily based on the measurement of physical
parameters
Annex B (informative) - Evaluation of a sterilization process
primarily based on biological inactivation and an
accompanying mechanical air removal procedure
Annex C (informative) - Temperature and pressure of saturated
steam for use in moist heat sterilization
Annex D (informative) - Special considerations for health care
settings
Annex E (informative) - Index of normative clauses/subclauses
of ISO 17665-1 and cited references or related
guidance given in ISO 17665-1 and ISO/TS 17665-2
Bibliography
Gives general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1.
| DocumentType |
Standard
|
| Pages |
60
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| CEN ISO/TS 17665-2:2009 | Identical |
| ISO/TS 17665-2:2009 | Identical |
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