Title Of Document
Single-use medical examination gloves -- Part 2: Specification for gloves made from poly(vinyl chloride)
Abstract
ISO 11193-2:2006 specifies requirements for packaged sterile, or bulked non-sterile, poly(vinyl chloride) 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 poly(vinyl chloride) gloves intended for use in handling contaminated medical materials. ISO 11193-2:2006 is intended as a reference for the performance and safety of poly(vinyl chloride) examination gloves. The safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures are outside the scope of ISO 11193-2:2006.
Category of Standards
Category 1
Document number assigned by ASEAN
ISO 11193-2 : 2006 Ed 1
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
BN
ID
KH
LA
MM
MY
PH
SG
TH
VN
Date of harmonisation in ASEAN
14/06/2021
Date of Latest Review
Links :
ISO 11193-2:2006 Single-use medical examination gloves — Part 2: Specification for gloves made from poly(vinyl chloride)