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BSI 22/30409085 DC 2022

BSI 22/30409085 DC 2022

$24.66

BS EN ISO 17665. Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices

Published By Publication Date Number of Pages
BSI 2022 161
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PDF Catalog

PDF Pages PDF Title
1 30409835-NC.pdf
3 ISO_DIS 17665 ed.2 – id.80271 Enquiry PDF (en).pdf
7 Foreword
8 Introduction
11 1 Scope
1.1 Inclusions
1.2 Exclusions
12 2 Normative references
3 Terms and definitions
22 4 General
23 5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Effects on materials
5.4 Environmental consideration
24 6 Process and equipment characterization
6.1 General
6.2 Process characterization
25 6.3 Saturated steam sterilization processes
26 6.4 Contained product sterilization processes
6.5 Equipment
28 7 Product definition
29 8 Process definition
31 9 Validation
9.1 General
32 9.2 Installation qualification (IQ)
33 9.3 Operational qualification (OQ)
9.4 Performance qualification (PQ)
35 9.5 Review and approval of validation
10 Routine monitoring and control
10.1 Routine monitoring
10.2 Operational status
36 10.3 Process success verification
10.4 Evaluation of additional data for saturated steam sterilization processes
37 10.5 Evaluation of additional data for sterilization processes for contained product
10.6 Record retention
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 Purpose
12.2 Demonstration of continued effectiveness
38 12.3 Recalibration
12.4 Equipment maintenance
12.5 Requalification
39 12.6 Assessment of change
40 Annex€A (informative) Guidance on the principles of moist heat sterilization and rationales for requirements
69 Annex€B (informative) Establishment and evaluation of a sterilization process primarily based on microbiological inactivation
82 Annex€C (informative) Establishing a sterilization process primarily based on the measurement of physical parameters
91 Annex€D (informative) Operating cycles
97 Annex€E (informative) Temperature and pressure of saturated steam for use in moist heat sterilization
102 Annex€F (informative) Guidance on the application of normative requirements in health care facility settings
126 Annex€G (informative) Guidance on the designation of a medical device to a product family and processing category for sterilization by moist heat
133 Annex€H (informative) Guidance on the application of the normative requirements in the industrial setting
158 Bibliography

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BSI 22/30409085 DC 2022
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