AS/NZS 4011.2:2014
Single-use medical examination gloves - Part 2: Specification for gloves made from poly(vinyl chloride)
Specifies requirements for packaged sterile, or bulked non-sterile, poly(vinyl chloride) 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 poly(vinyl chloride) gloves intended for use in handling contaminated medical materials. Adopted with national modifications from ISO 11193-2:2006.
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AS/NZS 4011.2:2014
COPYRIGHT
PREFACE
CONTENTS
1 Scope
2 Normative references
3 Classification
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 11193-2:2006 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 width and length
Figure 2 — Measurement points for thickness
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 4011.2:2014
COPYRIGHT
PREFACE
CONTENTS
1 Scope
2 Normative references
3 Classification
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 11193-2:2006 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 width and length
Figure 2 — Measurement points for thickness
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
Previous versions
AS/NZS 4011.2:2014
Online Library subscription pricing
The cost of your subscription will depend on which standards you want to access, and how many people in your organisation need to be able to access the Online Library subscription at the same time (concurrent users). During your subscription period, we are also able to make any necessary changes and ensure you are aware of any pricing changes that result. For a quote, contact our Online Library team by emailing onlinelibrary@standards.govt.nz.