GSO ISO 13408-6:2016
Gulf Standard
Historical
·
Approved on
22 December 2016
·
Aseptic processing of health care products -- Part 6: Isolator systems
GSO ISO 13408-6:2016 Files
English
17 Pages
Historical
Reference Language
41.35 BHD
GSO ISO 13408-6:2016 Scope
ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.
ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.
Best Sellers From Health Sector
BH GSO 1943:2022
GSO 1943:2021
Bahraini Technical Regulation
Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products
GSO 1943:2021
Gulf Technical Regulation
Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
BH GSO 2017:2023
GSO 2017:2023
Bahraini Standard
Personal Care and Baby Wet Wipes
Recently Published from Health Sector
GSO ISO 11978:2024
ISO 11978:2017
Gulf Standard
Ophthalmic optics — Contact lenses and contact lens care products — Labelling
GSO ISO 11608-6:2024
ISO 11608-6:2022
Gulf Standard
Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems
GSO ISO 16256:2024
ISO 16256:2021
Gulf Standard
Clinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
GSO ISO 14708-3:2024
ISO 14708-3:2017
Gulf Standard
Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators