I.S. EN ISO 14160:2021
Current
The latest, up-to-date edition.
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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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
This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
58
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 14160:2020 | Identical |
| EN ISO 14160:2021 | Identical |
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