02/564515 DC : DRAFT OCT 2002

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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BS EN ISO 8536-8 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR USE WITH PRESSURE INFUSION EQUIPMENT

Available format(s):

Superseded date: 19-08-2004

Language(s):

Published date: 23-11-2012

Publisher: British Standards Institution

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Foreword
1 Scope
2 Normative references
3 Designation
4 Materials
5 Physical requirements
  5.1 Particulate contamination
  5.2 Breaking strength
  5.3 Tightness
  5.4 Adapter with male conical fitting
  5.5 Injection site
  5.6 Fluid fitter
  5.7 Flow rate of infusion fluid
  5.8 Closure-piercing device
  5.9 Air inlet device
  5.10 Drip chamber and drip tube
  5.11 Tubing
  5.12 Flow regulator
  5.13 Protective caps
  5.14 Storage volume
6 Chemical requirements
7 Biological requirements
8 Packaging
9 Labelling
  9.1 Unit container
  9.2 Shelf or multi-unit container
Annex A (normative) Tests
      A.1 Physical tests
          A.1.1 Test for particulate contamination
          A.1.2 Test of breaking strength
          A.1.3 Test for tightness
          A.1.4 Testing of adapter with male conical fitting
                for tightness
          A.1.5 Test of injection site
          A.1.6 Test for efficiency of the fluid fitter
      A.2 Chemical tests
      A.3 Biological tests

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BS EN ISO 8536-8

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Comment Closes On
Committee	CH/212
Document Type	Draft
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Superseded
Superseded By	BS EN ISO 8536-8:2015

Standards Referencing This Book - (Show below) - (Hide below)

DIN 1314:1977-02	PRESSURE; BASIC CONCEPTS, UNITS
ISO 8536-4:2010	Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
IEC 60601-2-24:2012	Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
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
EN 980:2008	Symbols for use in the labelling of medical devices

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