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
HS
HS Range
MRA/Harmonised Regulations related to the Standard
ASEAN Agreement on Medical Device Directive (AMDD)
ASEAN Body responsible for Standard
ASEAN Medical Device Committee (AMDC)
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