BS EN ISO 8536-11:2015
Infusion equipment for medical use. Infusion filters for single use with pressure infusion equipment

Standard No.

BS EN ISO 8536-11:2015

Release Date

2015

Published By

British Standards Institution (BSI)

Latest

BS EN ISO 8536-11:2015

Replace

BS EN ISO 8536-11:2004

BS EN ISO 8536-11:2015 Referenced Document

• 93/42/EEC Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance; Publication of titles and references of harmonised standards under the directive)
• EN 15986 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
• EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
• EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Remains Current)
• EN ISO 8536-8:2015 Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)
• ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood*， 2017-04-01 Update
• ISO 11135 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 Anne*， 2023-12-23 Update
• ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4*， 2018-11-08 Update
• ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
• ISO 15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1
• ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 594-2 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
• ISO 7000 Graphical symbols for use on equipment — Index and synopsis*， 2019-07-12 Update
• ISO 8536-8 Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus

BS EN ISO 8536-11:2015 history

• 2015 BS EN ISO 8536-11:2015 Infusion equipment for medical use. Infusion filters for single use with pressure infusion equipment
• 2004 BS EN ISO 8536-11:2004 Infusion equipment for medical use - Infusion filters for use with pressure infusion equipment