AS/NZS 4011.1:2014
Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution
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. It also covers rubber gloves intended for use in handling contaminated medical materials and gloves with smooth surfaces or with textured surfaces over all or part of the glove. Adopted with national modifications from ISO 11193-1:2008.
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AS/NZS 4011.1:2014
COPYRIGHT
PREFACE
CONTENTS
1 Scope
2 Normative references
3 Classification
3.1 General
3.2 Type
3.3 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
6.4 Sterility
7 Packaging
8 Marking
8.1 General
8.2 Unit package
8.3 Multi-unit package
Annex A - Test for watertightness
A.1 Apparatus
A.2 Procedure
APPENDIX ZZ - VARIATIONS TO ISO 11193-1:2008 FOR AUSTRALIA AND NEW ZEALAND
ZZ1 SCOPE
ZZ2 VARIATIONS
APPENDIX ZA - TEST METHOD FOR GLOVE CUFF RUPTURE RESISTANCE
ZA1 SCOPE
ZA2 TEST METHOD
Table 1 — Inspection levels and AQLs
Table 2 — Dimensions and tolerances
TABLE 3 - TENSILE PROPERTIES
Figure 1 — Measurement points for the width and length of the glove
Figure 2 — Measurement points for the thickness of the glove
Figure A.1 — Mandrel
Figure A.2 — Holding device
FIGURE ZA1 SAMPLE HOLDING DEVICE WITH STAINLESS STEEL PIN
FIGURE ZA2 GLOVE SHOWING TEST SPECIMEN SITE
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AS/NZS 4011.1:2014
COPYRIGHT
PREFACE
CONTENTS
1 Scope
2 Normative references
3 Classification
3.1 General
3.2 Type
3.3 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
6.4 Sterility
7 Packaging
8 Marking
8.1 General
8.2 Unit package
8.3 Multi-unit package
Annex A - Test for watertightness
A.1 Apparatus
A.2 Procedure
APPENDIX ZZ - VARIATIONS TO ISO 11193-1:2008 FOR AUSTRALIA AND NEW ZEALAND
ZZ1 SCOPE
ZZ2 VARIATIONS
APPENDIX ZA - TEST METHOD FOR GLOVE CUFF RUPTURE RESISTANCE
ZA1 SCOPE
ZA2 TEST METHOD
Table 1 — Inspection levels and AQLs
Table 2 — Dimensions and tolerances
TABLE 3 - TENSILE PROPERTIES
Figure 1 — Measurement points for the width and length of the glove
Figure 2 — Measurement points for the thickness of the glove
Figure A.1 — Mandrel
Figure A.2 — Holding device
FIGURE ZA1 SAMPLE HOLDING DEVICE WITH STAINLESS STEEL PIN
FIGURE ZA2 GLOVE SHOWING TEST SPECIMEN SITE
AS/NZS 4011.1:2014
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.