ÖNORM EN ISO 5840-2:2015-12

Заменен

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)

Ссылочные документы

Действует

Cardiovascular implants -- Cardiac valve prostheses -- Part 1: General requirements — 64 стр.

Заменен

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

Действует

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

Instrumentation for use in association with non-active surgical implants -- General requirements — 24 стр.

Заменен

Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment — 5 стр.

Заменен

Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants — 3 стр.

Заменен

Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment — 6 стр.

Заменен

Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment — 9 стр.

Действует

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)

Заменен

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

Заменен

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

Действует

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)