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BS EN ISO 8536-8:2015

BS EN ISO 8536-8:2015

Current

Current

The latest, up-to-date edition.

Infusion equipment for medical use Infusion sets for single use with pressure infusion apparatus

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 General requirements
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
9 Packaging
10 Labelling
11 Disposal
Annex A (normative) - Physical tests
Annex B (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

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

This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar).

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 02/564515 DC (09/2004) Supersedes 13/30284721 DC. (06/2015)
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Current
Supersedes

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 11135-1:2007 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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Hardcopy - English
PDF - English
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