недоступно на русском языке

Текущий статус : Опубликовано (Hа стадии пересмотра)

Последний раз этот стандарт был пересмотрен в  2023. Поэтому данная версия остается актуальной
Формат Язык
PDF
Бумажный
  • CHF173
Пересчитать швейцарские франки (CHF) в ваша валюта

Тезис

ISO 80369-3:2016 specifies the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories.

NOTE 1 Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports.

It does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.

It does not specify requirements for small-bore connectors that are used for the following:

- gastric suction-only medical devices;

- oral-only medical devices;

EXAMPLE An oral tip syringe that is not intended to connect to another medical device. It is intended to administer directly to the patient's mouth.

- pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive enteral medical devices in place;

- medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device;

- gastrointestinal endoscopy equipment;

- skin level gastrostomy medical devices.

NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in ISO 80369-3 :2016 into enteral medical devices or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.

Standard first page

Preview 

Вы можете ознакомиться с данным стандартом в нашей онлайн-библиотеке (OBP)

Общая информация

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2016-07
    Этап
    : Подтверждение действия между-народного стандарта [90.93]
  • Версия
     : 1
  • Технический комитет :
    ISO/TC 210
    ICS :
    11.040.25 
  • RSS обновления

Жизненный цикл

Появились вопросы?

Ознакомьтесь с FAQ

Работа с клиентами
+41 22 749 08 88

Часы работы:
Понедельник – пятница: 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Интернет-магазин
  3. Каталог стандартов
  4. ТК
  5. ISO/TC 210
  6. ISO 80369-3:2016