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I.S. EN 13328-2:2002

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS

Available format(s)

Hardcopy , PDF

Superseded date

18-06-2008

Language(s)

English

Published date

01-01-2002

Preview

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 BSF port connectors
  4.1 Breathing system and patient connection ports
  4.2 Accessory ports
5 Test methods
  5.1 Ambient conditions of test
  5.2 Measurement of pressure drop
  5.3 Test method for gas leakage
6 Requirements for BSFs supplied sterile
  6.1 Sterility assurance
  6.2 Packaging of BSFs supplied sterile
7 Marking
  7.1 Use of symbols
  7.2 Marking of BSF
  7.3 Marking of package
  7.4 BSF intended for single use
8 Information to be provided by the manufacturer
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives

Covers requirements for non-filtration aspects of breathing system filters (BSFs) intended for the filtration of respired gases in humans when used with a breathing system.

DocumentType
Standard
Pages
16
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
EN 1281-2 : 1995 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - SCREW-THREADED WEIGHT-BEARING CONNECTORS
EN ISO 9360-1:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)
EN 1281-1:1997/A1:1998 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - CONES AND SOCKETS
EN 980:2008 Symbols for use in the labelling of medical devices
EN 13328-1 : 2001 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 1: SALT TEST METHOD TO ASSESS FILTRATION PERFORMANCE

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