Тезис
ISO 16061:2008 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.
ISO 16061:2008 also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.
With regard to safety, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.
Общая информация
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Текущий статус : WithdrawnДата публикации : 2008-12
Исправленный вариант (английский) : 2009-03
Исправленный вариант (Французский) : 2009-03 -
Версия : 2
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- ICS :
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Implants for surgery, prosthetics and orthotics
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Other medical equipment
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