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AS/NZS 4011:1997

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Single-use examination gloves - Specification

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

29-05-2024

Published date

05-05-1997

€45.79
Excluding VAT

1 - AS/NZS 4011:1997 SINGLE-USE EXAMINATION GLOVES - SPECIFICATION
4 - PREFACE
5 - CONTENTS
7 - 1 Scope
7 - 2 Normative references
7 - 3 Materials
7 - 4 Design
8 - 5 Sampling and selection of test pieces
8 - 5.1 Sampling
8 - 5.2 Selection of test pieces
8 - 6 Requirements
9 - 7 Packaging
9 - 8 Marking
9 - 8.1 Unit package
9 - 8.1.1 Sterile package
10 - 8.1.2 Non-sterile package
10 - 8.2 Multi-unit package
11 - Annex A - Test for watertightness
11 - A.1 Apparatus
11 - A.2 Procedure
14 - APPENDIX XX - AMENDMENTS TO ISO 11193 FOR APPLICATION IN AUSTRALIA AND IN NEW ZEALAND
14 - XX1 SCOPE
14 - XX2 AMENDMENTS
17 - APPENDIX YY - REQUIREMENT AND TEST METHOD FOR GLOVE CUFF RUPTURE RESISTANCE
17 - YY1 SCOPE
17 - YY2 REQUIREMENT
17 - YY3 TEST METHOD
17 - YY3.1 Principle
17 - YY3.2 Apparatus
17 - YY3.3 Procedure
18 - YY3.4 Report

Specifies requirements for single-use gloves intended to protect the user and a patient from cross-contamination during medical and dental examinations and diagnostic or therapeutic procedures. It also covers single-use gloves intended for use in handling contaminated medical materials, and includes particular requirements for regulatory authority application. It is technically equivalent to and reproduced from ISO 11193:1994. Appendices contain variations to materials, physical properties and marking requirements.

Committee
HE-013
DocumentType
Standard
ISBN
0 7337 1164 2
Pages
13
PublisherName
Standards Australia
Status
Superseded
SupersededBy
Supersedes
UnderRevision

This International Standard 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.This standard applies to single-use gloves that fit either hand, paired gloves and gloves by size. It covers gloves with smooth surfaces or with textured surfaces over part or all of the glove.This standard does not apply to gloves made from plastic film either of a dipped or welded construction or as a substitute for gloves for use in surgical procedures.This standard is intended as a reference for the performance and safety of rubber examination gloves. The safe and proper usage of examination gloves and sterilization procedures with subsequent handling and storage procedures are outside the scope of this International Standard.

First published in Australia as AS 4011-1992.
Second edition 1995.
Jointly revised and designated AS/NZS 4011:1997.

AS 1683.26-2001 Methods of test for elastomers Rubber, vulcanized or thermoplastic - Accelerated ageing and heat resistance tests
AS 1683.26-1994 Methods of test for elastomers Rubber, vulcanized - Accelerated ageing or heat-resistance tests
AS 1683.11-2001 Methods of test for elastomers Tension testing of vulcanized or thermoplastic rubber (Reconfirmed 2018)
AS 1199-1988 Sampling procedures and tables for inspection by attributes
AS 1683.11-1990 Methods of test for elastomers Tension testing of vulcanized rubber

AS 4273-1999 Design, installation and use of pharmaceutical isolators
SAA HB 9-1994 Occupational personal protection
AS/NZS 2161.1:2000 Occupational protective gloves Selection, use and maintenance

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