Тезис
This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors.
NOTE 1 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for themedical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.
This document does not specify requirements for the following small-bore connectors, which are specified in other documents:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports (ϲʿ 8637 [5] and applicable portion of ϲʿ 8638 [ 6] referencing blood compartment ports);
- haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ϲʿ 8637 [5]);
- infusion system closure piercing connectors (ϲʿ 8536-4 [4]).
NOTE 3 Manufacturers are encouraged to incorporate thesmall-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ϲʿ 80369, will be included.
NOTE 4 ϲʿ 80369-1:2018, Clause 7, specifies alternative methods of conformance with ϲʿ 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.
Жизненный цикл
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Ранее
Отозваноϲʿ 80369-7:2016
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Сейчас
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00
Предварительная стадия
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10
Стадия, связанная с внесением предложения
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20
Подготовительная стадия
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30
Стадия, связанная с подготовкой проекта комитета
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40
Стадия, связанная с рассмотрением проекта международного стандарта
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50
Стадия, на которой осуществляется принятие стандарта
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60
Стадия, на которой осуществляется публикация
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90
Стадия пересмотра
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95
Стадия, на которой осуществляется отмена стандарта
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00
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