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
30.01 , 30.05 , 30.06 , 33.04 , 33.06 , 33.07 , 34.04 , 34.07 , 37.05 , 38.08 , 38.21 , 38.22 , 39.24 , 39.26 , 40.14 , 40.15 , 48.18 , 48.23 , 59.06 , 62.11 , 62.12 , 63.07 , 66.02 , 84.19 , 84.21 , 85.39 , 87.13 , 87.14 , 90.01 , 90.02 , 90.04 , 90.06 , 90.11 , 90.13 , 90.18 , 90.19 , 90.20 , 90.21 , 90.22 , 90.25 , 94.02 , 94.05
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
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