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INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Publisher

National Standards Authority of Ireland

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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).

DocumentType	Standard
Pages	28
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 8536-9:2005

Standards	Relationship
BS EN ISO 8536-9:2015	Identical
NBN EN ISO 8536-9 : 2015	Identical
NS EN ISO 8536-9 : 2004	Identical
SN 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 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

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I.S. EN ISO 8536-9:2015

INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015)

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Abstract

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