ISO 10282:2023
Single-use sterile rubber surgical gloves — Specification
This document specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination.
This document is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves.
This document covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole glove.
This document is intended to be a reference for the performance and safety of rubber surgical gloves. The safe and proper usage of surgical gloves and sterilization procedures with subsequent handling, packaging and storage procedures are outside the scope of this document.
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
4.1 General
4.2 Material
4.3 Design
4.4 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 Watertightness
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
7.3.4 Force required to produce 300 % elongation
7.4 Sterility
8 Packaging
9 Marking
9.1 General
9.2 Inner package
9.3 Unit package
9.4 Multi-unit package
Annex A (normative) Measurement of dimensions (width, length and thickness)
Annex B (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 Material
4.3 Design
4.4 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 Watertightness
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
7.3.4 Force required to produce 300 % elongation
7.4 Sterility
8 Packaging
9 Marking
9.1 General
9.2 Inner package
9.3 Unit package
9.4 Multi-unit package
Annex A (normative) Measurement of dimensions (width, length and thickness)
Annex B (normative) Test method for watertightness
Bibliography