ISO 11193-1:2020
Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution
This document 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.
This document is intended as a reference for the performance and safety of rubber examination gloves. It does not cover the safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures.
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
4.1 General
4.2 Type
4.3 Finish
5 Materials
6 Sampling and selection of test pieces
6.1 Sampling
6.2 Selection of test pieces
7 Requirements
7.1 Dimensions
7.2 Water tightness
7.3 Tensile properties
7.3.1 General
7.3.2 Force at break and elongation at break before accelerated ageing
7.3.3 Force at break and elongation at break after accelerated ageing
7.4 Sterility
8 Packaging
9 Marking
9.1 General
9.2 Unit package
9.2.1 Sterile package
9.2.2 Non-sterile package
9.3 Multi-unit package
Annex A (normative) Test method for watertightness
Bibliography
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
4.1 General
4.2 Type
4.3 Finish
5 Materials
6 Sampling and selection of test pieces
6.1 Sampling
6.2 Selection of test pieces
7 Requirements
7.1 Dimensions
7.2 Water tightness
7.3 Tensile properties
7.3.1 General
7.3.2 Force at break and elongation at break before accelerated ageing
7.3.3 Force at break and elongation at break after accelerated ageing
7.4 Sterility
8 Packaging
9 Marking
9.1 General
9.2 Unit package
9.2.1 Sterile package
9.2.2 Non-sterile package
9.3 Multi-unit package
Annex A (normative) Test method for watertightness
Bibliography