SIST EN ISO 8536-12:2021 PDF

Name: SIST EN ISO 8536-12:2021 — Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)
SKU: SIST EN ISO 8536-12:2021
Price: 65.56 EUR
Availability: InStock

Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)

Название (английский):

SIST EN ISO 8536-12:2021

Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 18
Дата публикации:: 16 апреля 2021 г.
ICS:: 11.040.20
Технический комитет:: VAZ - Healthcare

Тип поставки:

Full version270 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:3 раб. дн. (перевод)

Цена:270 €

Описание (английский):

This document specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus. The functional requirements in this document also apply to inline check valves.

Abstract

Overview

Key topics and technical requirements

Scope & designation
- Applies to single‑use check valves and inline check valves for infusion systems.
- Labelling must follow Clause 9 requirements.
Materials & biocompatibility
- Materials must meet physical, chemical and biological requirements (see ISO 10993‑1 for biological evaluation).
- If rubber is used, ISO 8871‑1/2 requirements on extractables and characterization apply.
Physical performance
- Particulate contamination: Manufactured and finished to minimize particles; tested per ISO 8536‑4 limits.
- Leakage: No air leakage when tested (see Clause A.2).
- Connector compatibility: Inlets/outlets without tube bond ports must use ISO 80369‑compatible connectors.
- Counterflow pressure resistance: Must withstand 200 kPa in the counterflow direction (Clause A.3).
- Flow rate: Minimum flow rate of 6 L/h when connected to infusion equipment (Clause A.4).
- Blocking performance: Valve must close at a counterflow pressure of not more than 2 kPa (Clause A.5).
- Opening pressure: Valve must open at not more than 2 kPa (Clauses A.6.1/A.6.2); higher opening pressure defines anti‑siphon valves.
Sterility, labelling, packaging, disposal
- Sterility and pyrogenicity requirements included.
- Detailed labelling (unit and multi‑unit), packaging and disposal guidance are specified (Clauses 9–11).

Applications and users

Primary users:
- Medical device manufacturers of infusion sets and components.
- Design engineers developing single‑use check valves and inline safety features.
- Quality & regulatory teams ensuring conformity with European and international standards.
- Test laboratories performing physical, chemical and biological verification.
- Procurement and clinical engineering selecting compliant infusion components.
Practical applications:
- Preventing backflow and cross‑contamination in infusion therapy.
- Providing anti‑siphon protection in gravity feed and pressure infusion systems.
- Ensuring connector compatibility and patient safety in infusion lines.

Related standards

ISO 80369 (all parts) - small‑bore connectors for healthcare
ISO 8536‑4 - infusion sets for single use, gravity feed
ISO 8871‑1 / ISO 8871‑2 - elastomeric parts (extractables, characterization)
ISO 10993‑1 - biological evaluation of medical devices
ISO 15223‑1 - medical device symbols and labelling

Keywords: EN ISO 8536-12:2021, check valves, infusion equipment, single use, inline check valves, ISO 80369, opening pressure, counterflow resistance, medical device standard.

Технические детали

SKU: SIST EN ISO 8536-12:2021

Главная

Каталог

ISO 8536-12:2021

Действующий

Infusion equipment for medical use — Part 12: Check valves for single use

Overview ISO 8536-12:2021 - Infusion equipment for medical use - Part 12: Check valves for single use defines requirements for single‑use check valves used with infusion equipment (both gravity‑feed…

11 · PDF

25 €

ISO 80369-3:2016/Amd 1:2019

Действующий

Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral appli…

Overview ISO 80369-3:2016/Amd 1:2019 is an amendment to the international standard focused on small-bore connectors for liquids and gases in healthcare applications, specifically addressing connector…

6 · PDF

21 €

BS EN ISO 10993-11:2018

Действующий

Biological evaluation of medical devices. Tests for systemic toxicity.

38 · PDF

50 €

SIST EN ISO 8871-1:2005

Действующий

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous au…

Overview EN ISO 8871-1:2004 (ISO 8871-1:2003) specifies chemical test methods to classify and evaluate elastomeric parts for parenterals and pharmaceutical devices by determining extractables in aque…

22 · PDF

74 €

SIST EN ISO 8536-4:2020

Действующий

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)

Overview EN ISO 8536-4:2020 (ISO 8536-4:2019) - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed - is a harmonized European/ISO standard that defines requiremen…

25 · PDF

74 €

SIST EN ISO 8871-2:2020

Действующий

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and charact…

Overview EN ISO 8871-2:2020 - "Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization" (ISO 8871-2:2020) specifies procedures for the i…

31 · PDF

82 €

SIST EN ISO 15223-1:2021/A1:2026

Действующий

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General re…

Overview EN ISO 15223-1:2021/A1:2025 is a CEN-adopted amendment to the international standard on medical device symbols used in manufacturer-supplied information. This Amendment 1 (ISO 15223-1:2021/A…

38 · PDF

89 €

SIST EN ISO 8536-12:2021 PDF

Abstract

Overview

Похожие стандарты

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ISO 8536-12:2021

Infusion equipment for medical use — Part 12: Check valves for single use

ISO 80369-3:2016/Amd 1:2019

Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral appli…

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

SIST EN ISO 8871-1:2005

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous au…

SIST EN ISO 8536-4:2020

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)

SIST EN ISO 8871-2:2020

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and charact…

SIST EN ISO 15223-1:2021/A1:2026

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General re…