BAS EN ISO 11607-1:2010
Ambalaža za finalnu sterilizaciju medicinskih sredstava – dio 1: Zahtjevi za materijale, sterilne pregradne sisteme i sisteme pakovanja
Опште информације
Статус: Повучен
Број страна: 36
Језик: Енглески
Издање: 2.
Метода усвајања: Proglašavanje
Датум објаве: 29.06.2010
Технички комитет:
Директива:
90/385/EEC, Активна уградива медицинска средства
93/42/EEC, Медицинска средства;
93/42/EEC, Медицинска средства;
...
Апстракт
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.
Животни циклус
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Изворни документ и степен усаглашености
- EN ISO 11607-1:2009, идентичан
- ISO 11607-1:2006, идентичан