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ISO 11193-1

Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution

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Organization: ISO
Publication Date: 1 August 2020
Status: active
Page Count: 16
ICS Code (Other rubber and plastics products): 83.140.99
ICS Code (Hospital equipment): 11.140
scope:

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.

Document History

ISO 11193-1
August 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...
ISO 11193-1
June 15, 2012
Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution AMENDMENT 1
A description is not available for this item.
ISO 11193-1
September 1, 2008
Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution
This part of ISO 11193 specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect...
ISO 11193-1
May 15, 2007
Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution AMENDMENT 1
A description is not available for this item.
ISO 11193-1
June 15, 2005
Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution TECHNICAL CORRIGENDUM 1
A description is not available for this item.
ISO 11193-1
November 1, 2002
Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution
A description is not available for this item.
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References

This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
10993-10 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Published by ISO on November 1, 2021
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —...
This document references:
ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Published by ISO on September 1, 2017
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
This document references:
ISO 10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Published by ISO on January 1, 2021
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological...
This document references:
ISO 10993-13 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Published by ISO on June 15, 2010
This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices...
This document is referenced by:
ISO 23464 - Nitrile cleanroom gloves — Specification
Published by ISO on July 1, 2020
This document specifies the specification for ISO Class 4, ISO Class 5 and ISO Class 6 nitrile cleanroom gloves. It is applicable to cleanroom gloves made of acrylonitrile butadiene material.
This document is referenced by:
ISO 20437 - Natural rubber latex cleanroom gloves - Specification
Published by ISO on July 1, 2017
This document gives the specification for ISO 4, ISO 5 and ISO 6 cleanroom gloves. It is applicable to cleanroom gloves made of natural rubber latex (NRL).
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