BS EN ISO 15197:2003

Заменен

In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus — 46 стр.

Описание Изменения Ссылки Версии

Ссылочные документы

BS EN 13612:2002

Действует

Performance evaluation of in vitro diagnostic medical devices — 18 стр.

BS EN 13640:2002

Заменен

Stability testing of in vitro diagnostic reagents — 14 стр.

BS ISO 5725-1:1994

Действует

Accuracy (trueness and precision) of measurement methods and results. General principles and definitions — 26 стр.

BS ISO 5725-2:1994

Действует

Accuracy (trueness and precision) of measurement methods and results. Basic methods for the determination of repeatability and reproducibility of a standard measurement method — 62 стр.

BS ISO 5725-3:1994

Действует

Accuracy (trueness and precision) of measurement methods and results. Intermediate measures of the precision of a standard measurement method — 38 стр.

BS EN 375:2001

Заменен

Information supplied by the manufacturer with in vitro diagnostic reagents for professional use — 18 стр.

BS EN 592:2002

Заменен

Instructions for use for in vitro diagnostic instruments for self-testing — 14 стр.

BS EN 13532:2002

Действует

General requirements for in vitro diagnostic medical devices for self-testing — 12 стр.

BS EN 1041:1998

Заменен

Information supplied by the manufacturer with medical devices — 20 стр.

BS EN 591:2001

Заменен

Instructions for use for in vitro diagnostic instruments for professional use — 14 стр.

BS EN ISO 15197:2013

Заменен

In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus — 60 стр.

На этот документ ссылаются

BS EN 505:2000

Заменен

Roofing products from metal sheet. Specification for fully supported roofing products of steel sheet — 26 стр.

BS EN ISO 15197:2013

Заменен

In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus — 60 стр.