ISO 11193-1:2008 PDF

Scope: 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 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 part of ISO 11193 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.

ISO 11193-1:2008 Referenced Document

ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
ISO 15223 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2
ISO 188 Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests*， 2023-03-09 Update
ISO 23529 Rubber - General procedures for preparing and conditioning test pieces for physical test methods*， 2016-11-01 Update
ISO 2859-1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection; Technical Corrigendum 1
ISO 37 Rubber, vulcanized or thermoplastic - Determination of tensile stress-strain properties*， 2017-11-01 Update

2020 ISO 11193-1:2020 Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution
2012 ISO 11193-1:2008/Amd 1:2012 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution; Amendment 1
2008 ISO 11193-1:2008 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution
2007 ISO 11193-1:2002/Amd 1:2007 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution; Amendment 1
2005 ISO 11193-1:2002/Cor 1:2005 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution; Technical Corrigendum 1
2006 ISO 11193-1:2002 Single-use medical rubber examination gloves