ÖNORM EN ISO 16671:2018-01

Действует

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015 + Amd 1:2017) (consolidated version)

Ссылочные документы

Заменен

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.

Действует

Biological evaluation of medical devices -- Part 2: Animal welfare requirements — 20 стр.

Действует

Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems — 32 стр.

Действует

Clinical investigation of medical devices for human subjects -- Good clinical practice — 66 стр.

Действует

Non-active surgical implants -- General requirements — 20 стр.

Действует

Medical devices -- Application of risk management to medical devices — 90 стр.

Заменен

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements — 30 стр.

Действует

Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management — 34 стр.

Заменен

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)

Заменен

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)