Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

11-11-2015

Publisher

Asociacion Espanola de Normalizacion

Foreword
1 Scope
2 Normative references
3 General requirements
4 Designation
   4.1 Infusion set
   4.2 Air-inlet device
5 Materials
6 Physical requirements
   6.1 Particulate contamination
   6.2 Tensile strength
   6.3 Leakage
   6.4 Male conical fitting
   6.5 Injection site
   6.6 Fluid filter
   6.7 Flow rate of infusion fluid
   6.8 Closure-piercing device
   6.9 Air-inlet device
   6.10 Drip chamber and drip tube
   6.11 Tubing
   6.12 Flow regulator
   6.13 Protective caps
   6.14 Storage volume
7 Chemical requirements
8 Biological requirements
9 Packaging
10 Labelling
   10.1 Unit container
   10.2 Shelf or multi-unit container
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography

Provides users information on sterilized infusion sets for single use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).

Committee	CTN 111
DocumentType	Standard
Pages	24
PublisherName	Asociacion Espanola de Normalizacion
Status	Current
Supersedes	UNE-EN ISO 8536-8:2005

Standards	Relationship
ISO 8536-8:2015	Identical
NBN EN ISO 8536-8 : 2015	Identical
NEN EN ISO 8536-8 : 2015	Identical
NS EN ISO 8536-8 : 2004	Identical
I.S. EN ISO 8536-8:2015	Identical
UNI EN ISO 8536-8 : 2005	Identical
BS EN ISO 8536-8:2015	Identical
EN ISO 8536-8:2015	Identical
NF EN ISO 8536-8 : 2015	Identical
DIN EN ISO 8536-8:2015-11	Identical

ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 10993-4:2017	Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
EN 15986:2011	Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN ISO 8536-4:2013/A1:2013	INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013)
ISO 11135-1:2007	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 8536-9:2015	Infusion equipment for medical use Part 9: Fluid lines for single use with pressure infusion equipment
ISO 11137-2:2013	Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 8536-4:2010	Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
ISO 594-2:1998	Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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UNE-EN ISO 8536-8:2015

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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