Standard
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AS 23907:2023
[Current]Sharps injury protection — Requirements and test methods — Sharps containers (ISO 23907-2:2019, MOD)
AS 23907:2023 adopts and modifies ISO 23907 2:2019, which specifies requirements for reusable sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars, hypodermic needles and syringes
Published: 30/06/2023
Pages: 23
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements and recommendations
4.1 General
4.2 Design and construction
4.2.1 General
4.2.2 Container stability
4.2.3 Strength of handles
4.2.4 Aperture and closure
4.2.4.1 General
4.2.4.2 Requirements and recommendations for the aperture
4.2.4.3 Requirements and recommendations for the closure feature
4.2.5 Resistance to penetration
4.2.6 Resistance to damage or leakage after dropping
4.2.7 Resistance to damage or leakage after toppling
4.2.8 Fill line
4.3 Closure device
4.4 Monitoring of reuses
4.5 Cleaning and decontamination
4.5.1 Cleaning and decontamination process
4.5.2 Microbiological validation
5 Lifespan simulation prior to testing
5.1 General
5.2 Conditioning
5.3 Tumbling with sharps simulation
5.4 Transport simulations
5.5 Processing simulations
6 Test methods
6.1 Container stability
6.1.1
6.1.2
6.2 Strength of handle(s)
6.2.1
6.2.2
6.2.3
6.2.4
6.3 Resistance to penetration
6.3.1 Apparatus
6.3.1.1
6.3.1.2
6.3.1.3
6.3.1.4
6.3.2 Procedure
6.3.2.1
6.3.2.2
6.3.2.3
6.3.2.4
6.3.2.5
6.4 Resistance to damage and leakage after dropping
6.4.1 Apparatus
6.4.1.1
6.4.1.2
6.4.1.3
6.4.2 Procedure
6.4.2.1 Condition the sharps container at (23 ± 2) °C for at least 2 h and carry out the test at the same temperature.
6.4.2.2
6.4.2.3
6.4.2.4
6.5 Resistance to spillage by toppling
6.5.1 Apparatus
6.5.2 Procedure
6.5.2.1
6.5.2.2
6.5.2.3
6.5.2.4
7 Quality monitoring: Post decontamination quality assurance
8 Labelling and marking and instructions for use
8.1 Labelling and marking
8.2 Instructions for use
Appendix A
A.1 General
A.2 Surface sampling validation of 4-Log challenge suspension
A.2.1 Background
A.2.2 Enumerating organisms from 104/ml application
A.2.3 Preparing challenge suspension
A.3 Microbiological validation of decontamination process
A.3.1 Materials
A.3.2 Challenge suspension preparation
A.3.3 Confirmation of challenge suspension density (and positive control)
A.3.4 Validation of the decontamination process
A.3.5 Expression of results
A.3.6 Evaluation of results
Bibliography
Cited references in this standard
Content history
[Current]
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