Standard
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AS/NZS 4179:2014
[Pending Revision]Single-use sterile rubber surgical gloves - Specification (ISO 10282:2014, MOD)
Adopts ISO 10282:2014 to specify requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves.
Published: 21/07/2014
Pages: 17
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
1 Scope
2 Normative references
3 Classification
3.1 General
3.2 Type
3.3 Design
3.4 Finish
4 Materials
5 Sampling and selection of test pieces
5.1 Sampling
5.2 Selection of test pieces
6 Requirements
6.1 Dimensions
6.2 Watertightness
6.3 Tensile properties
6.3.1 General
6.3.2 Force at break and elongation at break before accelerated ageing
6.3.3 Force at break and elongation at break after accelerated ageing
6.3.4 Force required to produce 300 % elongation
6.4 Sterility
7 Packaging
8 Marking
8.1 General
8.1.1
8.1.2
8.1.3
8.2 Inner package
8.3 Unit package
8.4 Multi-unit package
Annex A
A.1 Apparatus
A.1.1
A.1.2
A.1.3
A.2 Procedure
Appendix ZZ
ZZ1 Scope
ZZ2 Variations
Appendix ZA
ZA1 Scope
ZA2 Test method
ZA2.1 Principle
ZA2.2 Apparatus
ZA2.3 Procedure
ZA2.4 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]
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — AMENDMENT 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific
Content history
[Superseded]
[Superseded]
[Superseded]
DR AS/NZS 4179
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