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BS EN ISO 17665:2024

BS EN ISO 17665:2024

$215.11

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 2024 176
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This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Annex ZA (informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
12 Annex ZB (informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
17 Foreword
18 Introduction
21 1 Scope
1.1 Inclusions
1.2 Exclusions
22 2 Normative references
3 Terms and definitions
32 4 General
33 5 Sterilizing agent characterization
5.1 Sterilizing agent
34 5.2 Microbicidal effectiveness
5.3 Effects on materials
5.4 Environmental consideration
6 Process and equipment characterization
6.1 General
6.2 Process characterization
35 6.3 Saturated steam sterilization processes
36 6.4 Contained product sterilization processes
37 6.5 Equipment
38 7 Product definition
40 8 Process definition
42 9 Validation
9.1 General
43 9.2 Installation qualification (IQ)
9.3 Operational qualification (OQ)
44 9.4 Performance qualification (PQ)
46 9.5 Review and approval of validation
10 Routine monitoring and control
10.1 Routine monitoring
10.2 Operational status
47 10.3 Process verification
10.4 Evaluation of additional data for saturated steam sterilization processes
10.5 Evaluation of additional data for contained product sterilization processes.
48 10.6 Record retention
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 Purpose
12.2 Demonstration of continued effectiveness
49 12.3 Recalibration
12.4 Equipment maintenance
12.5 Requalification
50 12.6 Assessment of change
51 Annex A (informative) Guidance on the principles of moist heat sterilization and rationales for requirements
79 Annex B (informative) Establishment and evaluation of a sterilization process primarily based on microbiological inactivation
93 Annex C (informative) Establishment and evaluation of a sterilization process primarily based on the measurement of physical parameters
103 Annex D (informative) Examples of moist heat sterilization cycles
109 Annex E (informative) Temperature and pressure of saturated steam for use in moist heat sterilization
113 Annex F (informative) Guidance on the application of the normative requirements in health care facilities
138 Annex G (informative) Guidance on the designation of a medical device to a product family and processing category for sterilization by moist heat
146 Annex H (informative) Guidance on the application of the normative requirements in industrial settings
170 Bibliography

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BS EN ISO 17665:2024
$215.11