13/30284773 DC : 0

Superseded

BS EN ISO 8536-10 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT

Available format(s)

Hardcopy , PDF

Superseded date

30-06-2015

Language(s)

English

Publisher

British Standards Institution

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

BS EN ISO 8536-10

Committee	CH/212
DocumentType	Draft
Pages	19
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 8536-10:2015

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
ISO 7886-1:2017	Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 8536-4:2010	Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ISO 11134:1994	Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
ISO 11137:1995	Sterilization of health care products Requirements for validation and routine control Radiation sterilization
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