ISO 11193-2:2006 PDF

Overview

ISO 11193-2:2006 is the International Organization for Standardization specification for single-use medical examination gloves made from poly(vinyl chloride) (PVC). The standard defines performance, materials and quality requirements for packaged sterile or bulk non-sterile PVC examination gloves intended to protect patients and users from cross‑contamination. It is a reference for manufacturers, test laboratories and regulatory staff; it does not cover detailed instructions for safe use, sterilization procedures or storage practices.

Key topics and technical requirements

• Scope & classification: Covers PVC (plasticized poly(vinyl chloride)) single‑use examination gloves. Gloves are classified by finish: textured, smooth, powdered, powder-free.
• Materials: Gloves must be manufactured from plasticized PVC; any pigments, powders or surface treatments must be non‑toxic and disclosed on request. Biocompatibility must conform to relevant parts of ISO 10993.
• Sampling & inspection: Lot inspection and sampling follow ISO 2859‑1. Key AQLs: physical dimensions and tensile properties AQL 4.0, watertightness AQL 2.5.
• Dimensions & thickness: Width and length measured at specified glove points. Single‑wall thickness minima (where measured): smooth area ≥ 0.08 mm, textured area ≥ 0.11 mm; palm centre thickness values are specified in the standard.
• Watertightness: Annex A defines a watertightness test using a hollow mandrel and 1 000 cm3 of water (≤36 °C); leakage within 40 mm of the cuff is disregarded.
• Tensile properties & ageing: Tensile testing per ISO 37 and accelerated ageing per ISO 188. Minimum requirements: force at break ≥ 7.0 N and elongation at break ≥ 350%, both before and after accelerated ageing.
• Packaging & marking: Sterile glove packaging, labelling elements and unit/multi‑unit marking requirements are specified (manufacturer, material, finish, size, lot number, date of manufacture, “FOR SINGLE USE”, sterile/non‑sterile, and a plasticizer disclosure/warning).

Practical applications and users

• Manufacturers: product design, material selection, production QC and final release criteria for PVC examination gloves.
• Quality & testing laboratories: sampling plans, performance testing (watertightness, tensile, thickness) and compliance verification.
• Regulatory and procurement teams: product specifications for tendering, conformity evidence and labelling requirements.
• Healthcare supply chain: acceptance testing and supplier audits to ensure PPE meets required safety benchmarks.

Related standards

• ISO 11193-1 (latex/rubber examination gloves)
• ISO 10993 (biological evaluation of medical devices)
• ISO 37 (tensile testing), ISO 188 (accelerated ageing)
• ISO 2859-1 (sampling by attributes), ISO 15223 (medical device symbols), ISO 23529 (test piece preparation)

Keywords: ISO 11193-2, PVC gloves, poly(vinyl chloride) examination gloves, medical examination gloves specification, watertightness test, tensile properties, sterile examination gloves, glove marking and packaging.