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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

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   VN 

Date of harmonisation in ASEAN

Date of Latest Review

Links :

ISO 11193-2:2006 Single-use medical examination gloves — Part 2: Specification for gloves made from poly(vinyl chloride)