I.S. EN ISO 14160:2021
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Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)
Hardcopy , PDF
English
19-07-2021
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (informative) Guidance for the application of this document
Annex B (normative) Determination of lethal rate of the sterilization process
Annex C (informative) Flowchart for microbicidal effectiveness (see 5.3), processdefinition (see Clause 8), and microbiological performance qualification (see 9.4.2)
Bibliography
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