AS/NZS 4011:1997
Single-use examination gloves - Specification
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.
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AS/NZS 4011:1997 SINGLE-USE EXAMINATION GLOVES-SPECIFICATION
PREFACE
CONTENTS
1 Scope
2 Normative references
3 Materials
4 Design
5 Sampling and selection of test pieces
5.1 Sampling
5.2 Selection of test pieces
6 Requirements
7 Packaging
8 Marking
8.1 Unit package
8.1.1 Sterile package
8.1.2 Non-sterile package
8.2 Multi-unit package
Annex A - Test for watertightness
A.1 Apparatus
A.2 Procedure
APPENDIX XX - AMENDMENTS TO ISO 11193 FOR APPLICATION IN AUSTRALIA AND IN NEW ZEALAND
XX1 SCOPE
XX2 AMENDMENTS
APPENDIX YY - REQUIREMENT AND TEST METHOD FOR GLOVE CUFF RUPTURE RESISTANCE
YY1 SCOPE
YY2 REQUIREMENT
YY3 TEST METHOD
YY3.1 Principle
YY3.2 Apparatus
YY3.3 Procedure
YY3.4 Report
Amendments
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AS/NZS 4261:1994
Reusable containers for the collection of sharp items used in human and animal medical applications
AS/NZS 4011:1997 SINGLE-USE EXAMINATION GLOVES-SPECIFICATION
PREFACE
CONTENTS
1 Scope
2 Normative references
3 Materials
4 Design
5 Sampling and selection of test pieces
5.1 Sampling
5.2 Selection of test pieces
6 Requirements
7 Packaging
8 Marking
8.1 Unit package
8.1.1 Sterile package
8.1.2 Non-sterile package
8.2 Multi-unit package
Annex A - Test for watertightness
A.1 Apparatus
A.2 Procedure
APPENDIX XX - AMENDMENTS TO ISO 11193 FOR APPLICATION IN AUSTRALIA AND IN NEW ZEALAND
XX1 SCOPE
XX2 AMENDMENTS
APPENDIX YY - REQUIREMENT AND TEST METHOD FOR GLOVE CUFF RUPTURE RESISTANCE
YY1 SCOPE
YY2 REQUIREMENT
YY3 TEST METHOD
YY3.1 Principle
YY3.2 Apparatus
YY3.3 Procedure
YY3.4 Report
Amendments
AS/NZS 4011:1997
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.