Infusion equipment for medical use Fluid lines for single use with pressure infusion equipment

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-30-2015

Publisher

British Standards Institution

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Physical requirements
6 Chemical requirements
7 Biological requirements
8 Packaging
9 Labelling
10 Disposal
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Storage volume
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EC Directive 93/42/EEC on medical devices
Bibliography

Pertains to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).

This part of ISO 8536 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by this part of ISO 8536: syringe pump lines (SPL); connecting lines (CL); lines with integrated injection cannula (LIC). In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

Committee	CH/212
DevelopmentNote	Supersedes 02/564516 DC. (01/2005) Supersedes 13/30284770 DC. (06/2015)
DocumentType	Standard
Pages	24
PublisherName	British Standards Institution
Status	Current
Supersedes	13/30284770 DC : 0 02/564516 DC : DRAFT OCT 2002 BS EN ISO 8536-9:2004

Standards	Relationship
NBN EN ISO 8536-9 : 2015	Identical
NS EN ISO 8536-9 : 2004	Identical
SN EN ISO 8536-9 : 2015	Identical
I.S. EN ISO 8536-9:2015	Identical
NF EN ISO 8536-9 : 2015	Identical
UNI EN ISO 8536-9 : 2005	Identical
DIN EN ISO 8536-9:2015-11	Identical
NEN EN ISO 8536-9 : 2015	Identical
ISO 8536-9:2015	Identical
UNE-EN ISO 8536-9:2015	Identical
EN ISO 8536-9:2015	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
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 8536-8:2015	Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus
EN ISO 8536-11:2015	Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)
EN ISO 10993-4:2017	Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
EN ISO 7864:2016	Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
EN ISO 8536-10:2015	Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
ISO 8536-11:2015	Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment
ISO 11137-2:2013	Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 7864:2016	Sterile hypodermic needles for single use — Requirements and test methods
ISO 8536-4:2010	Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ISO 8536-10:2015	Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipment
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

View more information

US$237.18

Excluding Tax where applicable

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Access your standards online with a subscription

Features

Simple online access to standards, technical information and regulations.
Critical updates of standards and customisable alerts and notifications.
Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

Get in touch with us

BS EN ISO 8536-9:2015

Infusion equipment for medical use Fluid lines for single use with pressure infusion equipment

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory