Standard
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AS/NZS 11193.1:2026
[Current]Single-use medical examination gloves, Part 1: Specification for gloves made from rubber latex or rubber solution (ISO 11193-1:2020, MOD)
AS/NZS 11193.1:2026 adopts and modifies ISO 11193 1:2020, which specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination.
Published: 13/03/2026
Pages: 14
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
4.1 General
4.2 Type
4.3 Finish
5 Materials
6 Sampling and selection of test pieces
6.1 Sampling
6.2 Selection of test pieces
7 Requirements
7.1 Dimensions
7.2 Water tightness
7.3 Tensile properties
7.3.1 General
7.3.2 Force at break and elongation at break before accelerated ageing
7.3.3 Force at break and elongation at break after accelerated ageing
7.4 Sterility
8 Packaging
9 Marking
9.1 General
9.2 Unit package
9.2.1 Sterile package
9.2.2 Non-sterile package
9.3 Multi-unit package
Appendix A
A.1 Apparatus
A.1.1
A.1.2
A.1.3
A.2 Procedure
Bibliography
Appendix ZA
ZA.1 Scope
ZA.2 Test method
ZA.2.1 Principle
ZA.2.2 Apparatus
ZA.2.3 Procedure
ZA.2.4 Report
Cited references in this standard
[Current]
Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
[Current]
Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
[Current]
Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 10993 (all parts)
— Biological evaluation of medical devices
[Current]
Rubber — General procedures for preparing and conditioning test pieces for physical test methods
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