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BS EN ISO 14160:2021

BS EN ISO 14160:2021

$198.66

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

Published By Publication Date Number of Pages
BSI 2021 54
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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.

This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1).

This document is not applicable to material of human origin.

This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3).

This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites.

The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4).

This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see NOTE 5).

This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6).

Guidance 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 is provided in informative Annex A.

NOTE 1

The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1 is important. ISO 18362 provides information on control of microbial risks during processing of cell-based health-care products.

NOTE 2

Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2 .

NOTE 3

The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3 .

NOTE 4

Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a specified sterilization process.

NOTE 5

Such testing is a crucial part of the design and development of a medical device.

NOTE 6

ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.

NOTE 7

Standards for quality management systems (see ISO 13485 ) can be used in the control of all stages of manufacture including the sterilization process.

PDF Catalog

PDF Pages PDF Title
2 undefined
9 Annex ZA (informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
13 Foreword
14 Introduction
16 1 Scope
17 2 Normative references
3 Terms and definitions
21 4 General
22 5 Sterilizing agent characterization
5.1 General
5.2 Sterilizing agent
5.3 Microbicidal effectiveness
23 5.4 Effects on materials
5.5 Safety and the environment
6 Process and equipment characterization
6.1 General
6.2 Process characterization
24 6.3 Equipment characterization
7 Product definition
25 8 Process definition
8.1 Purpose
8.2 Determination of the inactivation kinetics
26 8.3 Method for neutralization
8.4 Safety quality and performance
9 Validation
9.1 General
27 9.2 Installation qualification
9.2.1 Equipment
9.2.2 Installation
9.3 Operational qualification
28 9.4 Performance qualification
9.4.1 General
9.4.2 Microbiological performance qualification (MPQ)
29 9.4.3 Physical performance qualification
30 9.4.4 Aseptic processing qualification
9.5 Review and approval of validation
31 10 Routine monitoring and control
32 11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
33 12.2 Maintenance of equipment
12.3 Requalification
12.4 Assessment of change
34 Annex A (informative) Guidance for the application of this document
46 Annex B (normative) Determination of lethal rate of the sterilization process
50 Annex C (informative) Flowchart for microbicidal effectiveness (see 5.3), process definition (see Clause 8), and microbiological performance qualification (see 9.4.2)
51 Bibliography

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BS EN ISO 14160:2021
$198.66