DD CEN ISO/TS 17665-2:2009
Superseded
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Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1
Hardcopy , PDF
English
28-02-2009
08-05-2024
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.
| Committee |
CH/198
|
| DocumentType |
Standard
|
| Pages |
56
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO17665-1.
NOTE1 The structure of the main body of this ISO Technical Specification (Clauses1 to 12) corresponds to the structure of ISO17665-1, so that the guidance given under a particular clause or subclause of this part of ISO17665 applies to the requirements given in the corresponding clause or subclause of ISO17665-1. For example, guidance for subclause5.2 of ISO17665-1:2006 is given in 5.2. This guidance is provided in addition to the guidance given in ISO17665-1:2006, AnnexA. See also AnnexeE.
NOTE2 Special considerations specific to sterilization processes performed in health care facilities are given in AnnexD.
| Standards | Relationship |
| CEN ISO/TS 17665-2:2009 | Identical |
| ISO/TS 17665-2:2009 | Identical |
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