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BS EN ISO 14160:2021 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 >
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BS EN ISO 14160:2021 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, 2021
- undefined [Go to Page]
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General
- 5 Sterilizing agent characterization
- 5.1 General
- 5.2 Sterilizing agent
- 5.3 Microbicidal effectiveness
- 5.4 Effects on materials
- 5.5 Safety and the environment
- 6 Process and equipment characterization
- 6.1 General
- 6.2 Process characterization
- 6.3 Equipment characterization
- 7 Product definition
- 8 Process definition
- 8.1 Purpose
- 8.2 Determination of the inactivation kinetics
- 8.3 Method for neutralization
- 8.4 Safety quality and performance
- 9 Validation
- 9.1 General
- 9.2 Installation qualification
- 9.2.1 Equipment
- 9.2.2 Installation
- 9.3 Operational qualification
- 9.4 Performance qualification
- 9.4.1 General
- 9.4.2 Microbiological performance qualification (MPQ)
- 9.4.3 Physical performance qualification
- 9.4.4 Aseptic processing qualification
- 9.5 Review and approval of validation
- 10 Routine monitoring and control
- 11 Product release from sterilization
- 12 Maintaining process effectiveness
- 12.1 General
- 12.2 Maintenance of equipment
- 12.3 Requalification
- 12.4 Assessment of change
- 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), process definition (see Clause 8), and microbiological performance qualification (see 9.4.2)
- Bibliography [Go to Page]