Back

EVS-EN ISO 8536-4:2020

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

General information

Valid from 17.02.2020
Base Documents
ISO 8536-4:2019; EN ISO 8536-4:2020
ICS Groups
11.040.20 Transfusion, infusion and injection equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
17.02.2020
Main
EVS-EN ISO 8536-4:2020
02.04.2013
Amendment
EVS-EN ISO 8536-4:2013/A1:2013
05.03.2013
Main
EVS-EN ISO 8536-4:2013
This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

Required fields are indicated with *

*
*
*
PDF
19.52 € incl tax
PDF redline
25.38 € incl tax
Paper
19.52 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English (PDF 427 KB)

Related products

Main

EVS-EN ISO 80369-1:2018

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018)
Newest version Valid from 03.12.2018
Main

EVS-EN 60601-2-24:2015

Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
Newest version Valid from 08.06.2015
Main

EVS-EN 60601-2-40:2019

Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Newest version Valid from 16.01.2019
Main

EVS-EN IEC 60601-2-41:2021

Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
Newest version Valid from 31.12.2021

Customers who bought this item also bought

Amendment

EVS-EN 62366-1:2015/A1:2020

Medical devices - Part 1: Application of usability engineering to medical devices
Valid from 17.08.2020
Main

EVS-EN ISO 11607-1:2020

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Valid from 03.02.2020
Amendment

EVS-EN ISO 11135:2014/A1:2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
Newest version Valid from 02.12.2019
Main

EVS-EN ISO 11607-2:2020

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Valid from 03.02.2020

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English