ISO 10282:2014 PDF

Scope: This International Standard specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves. It covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole glove. This International Standard is intended as 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 International Standard.

ISO 10282:2014 Referenced Document

ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-3:2003 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 188:2011 Rubber, vulcanized or thermoplastic - Accelerated ageing and heat resistance tests
ISO 2859-1:1999 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 37:2011 Rubber, vulcanized or thermoplastic - Determination of tensile stress-strain properties

2023 ISO 10282:2023 Single-use sterile rubber surgical gloves — Specification
2014 ISO 10282:2014 Single-use sterile rubber surgical gloves - Specification
2005 ISO 10282:2002/Cor 1:2005 Single-use sterile rubber surgical gloves - Specification; Technical Corrigendum 1
2002 ISO 10282:2002 Single-use sterile rubber surgical gloves - Specification
1994 ISO 10282:1994 Single-use sterile surgical rubber gloves - Specification