This part of IS0 11 193 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 crosscontamination. It also covers rubber gloves intended for use in handling contaminated medical materials and gloves with smooth surfaces or with textured surfaces over part or all of the glove.
This part of IS0 11193 is intended as a reference for the performance and safety of rubber examination gloves. The
safe and proper usage of examination gloves and sterilizatioprocedures with subsequent handling, packaging and
storage procedures are outside the scope of this part of IS0 11193.
ISO 11193-1:2002 Referenced Document
GB/T 2828.1 Inspection procedure by count sampling part 1: Lot by lot inspection sampling plan retrieved by acceptance quality limit (AQL)*, 2013-02-15 Update
ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*, 2019-11-26 Update
ISO 188 Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests*, 2023-03-09 Update
ISO 37 Rubber, vulcanized or thermoplastic - Determination of tensile stress-strain properties*, 2017-11-01 Update
ISO 4648 Rubber, vulcanized or thermoplastic; determination of dimensions of test pieces and products for test purposes
ISO 11193-1:2002 history
2020ISO 11193-1:2020 Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution
2012ISO 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
2008ISO 11193-1:2008 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution
2007ISO 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
2005ISO 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
2006ISO 11193-1:2002 Single-use medical rubber examination gloves