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Title Of Document

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

Abstract

ISO 11193-1:2008 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.

Category of Standards

Category 1

Document number assigned by ASEAN

ISO 11193-1 : 2008 Ed 2

ICS

HS

HS Range

MRA/Harmonised Regulations related to the Standard

ASEAN Agreement on Medical Device Directive (AMDD)

ASEAN Body responsible for Standard

Medical Device Product Working Group (MDPWG)

Member States

 ID   PH   TH   VN 

Date of harmonisation in ASEAN

Date of Latest Review

Links :

ISO 11193-1:2008 Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution