Povučen
ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.
POVUČEN
ISO 11607:2003
POVUČEN
ISO 11607-1:2006
95.99
Povučen
31. 1. 2019.
POVUČEN
ISO 11607-1:2006/Amd 1:2014
OBJAVLJEN
ISO 11607-1:2019
Ambalaža za terminalno sterilizovana medicinska sredstva - Deo 1: Zahtevi za materijale, sterilne pregradne sisteme i ambalažne sisteme
95.99 Povučen
Ambalaža za terminalno sterilisana medicinska sredstva — Deo 1: Zahtevi za materijale, sterilne pregradne sisteme i ambalažne sisteme
95.99 Povučen
Ambalaža za terminalno sterilisana medicinska sredstva – Deo 1: Zahtevi za materijale, sterilne pregradne sisteme i ambalažne sisteme
95.99 Povučen