Search Harmonised Standards in ASEAN: ASEAN BODY

Title Of Document

Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes

Abstract

ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

Category of Standards

Category 1

Document number assigned by ASEAN

ISO 11607-2:2006

ICS

HS

30.0130.0530.0633.0433.0633.0734.0434.0737.0538.0838.2138.2239.2439.2640.1440.1548.1848.2359.0662.1162.1263.0766.0284.1984.2185.3987.1387.1490.0190.0290.0490.0690.1190.1390.1890.1990.2090.2190.2290.2594.0294.05

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   TH 

Date of harmonisation in ASEAN

Date of Latest Review

Links :

ISO 11607-2:2006 Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes