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DIN EN 13328-2:2004-03

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 ANESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS

Available format(s)

Hardcopy , PDF

Superseded date

01-06-2008

Language(s)

English

Published date

12-01-2013

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

Gives 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. It addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied.

DocumentType
Standard
Pages
9
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded

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

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