I.S. EN ISO 17665-1:2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Hardcopy , PDF
English
01-01-2006
09-05-2024
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.
Foreword
Introduction
1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Quality management system elements
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement - Control
of non-conforming product
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Materials effects
5.4 Environmental consideration
6 Process and equipment characterization
6.1 Process
6.1.1 General
6.1.2 Saturated steam processes
6.1.3 Contained product processes
6.2 Equipment
7 Product definition
8 Process definition
9 Validation
9.1 General
9.2 Installation qualification (IQ)
9.2.1 Equipment
9.2.2 Installation
9.2.3 Function
9.3 Operational qualification (OQ)
9.4 Performance qualification (PQ)
9.5 Review and approval of 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) Guidance
Annex B (informative) Process definition based on
inactivation of the microbial population in
its natural state (bioburden-based method)
Annex C (informative) Process definition based on the
inactivation of a reference microorganism and
a knowledge of bioburden on product items to
be sterilized (combined bioburden/biological
indicator based method)
Annex D (informative) Conservative process definition
based on inactivation of reference microorganisms
(overkill method)
Annex E (informative) Operating cycles
Bibliography
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directives 90/385/EEC, 93/42/EEC and 98/79/EEC
Specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
| DevelopmentNote |
Supersedes I.S. EN 554 (10/2006)
|
| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN EN ISO 17665-1 : 2006 | Identical |
| BS EN ISO 17665-1:2006 | Identical |
| NBN EN ISO 17665-1 : 2006 | Identical |
| NF EN ISO 17665-1 : 2006 | Identical |
| ISO 17665-1:2006 | Identical |
| NS EN ISO 17665-1 : 1ED 2006 | Identical |
| EN ISO 17665-1:2006 | Identical |
| DIN EN ISO 17665-1:2006-11 | Identical |
| UNE-EN ISO 17665-1:2007 | Identical |
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