Specifies safety and performance requirements for medical suction equipment powered from a vacuum or pressure source. In particular, it applies to connections to the terminal unit of vacuum systems. Requirements supplement or modify the corresponding clauses in ISO 10079-3, Medical suction equipment, Part 3: Suction equipment powered from a vacuum or pressure source. This Standard is technically equivalent to and has been reproduced from ISO 10079-3:1992.
Table of contents
Header
About this publication
PREFACE
1 SCOPE
2 REFERENCED DOCUMENTS
3 DEFINITIONS
4 CLEANING AND STERILIZATION
4.1
4.2
4.3
4.4
5 DESIGN REQUIREMENTS
5.1 Collection container
5.1.1
5.1.2
5.1.3
5.1.4
5.1.5
5.2 Suction tubing
5.2.1
5.2.2
6 OPERATIONAL REQUIREMENTS
6.1 Overfill protection
6.1.1
6.1.2
6.2 Spillage
6.3 Air leakage
6.3.1 Collection containers for general use
6.3.1.1
6.3.1.2
6.3.2 Collection containers for thoracic drainage
6.3.2.1
6.3.2.2
6.4 Exhaust air
6.5 Protective devices
6.5.1 Positive and negative pressure protection
6.5.1.1
6.5.1.2
6.5.2 Filter assembly
6.5.2.1
6.5.2.2
6.5.3 Anti-blowback in suction equipment powered by a venturi device
6.5.3.1
6.5.3.2
6.5.4 Electrical protection
6.6 Vacuum indicators
6.6.1
6.6.2
6.6.3
6.6.4
6.6.5
6.6.6
6.6.7
6.6.8
6.7 Dismantling and reassembly
6.8 Mechanical shock
6.9 Immersion in water
6.10 Stability
7 PHYSICAL REQUIREMENTS
7.1 Dimensions
7.2 Mass
8 PERFORMANCE REQUIREMENTS FOR VACUUM AND FLOW
8.1 General
8.2 High vacuum, high flow equipment
8.3 Medium vacuum equipment
8.4 Pharyngeal suction equipment
8.5 Low vacuum, low flow equipment
8.6 Low vacuum, high flow equipment
8.7 Thoracic drainage equipment
9 GAS SUPPLY
9.1 Gas supply pressure
9.2 Separate gas connections
10 VACUUM REGULATOR
10.1 Vacuum regulators having a fixed setting
10.2 Vacuum regulators having a variable control
11 RESISTANCE TO HARSH ENVIRONMENTS
11.1 Operating conditions
11.2 Storage
12 MARKING
12.1 Equipment
12.2 Equipment or carrying case
13 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
APPENDIX A
A1 TEST FOR RESISTANCE TO IMPLOSION, CRACKING OR PERMANENT DEFORMATION
A2 TEST FOR SUCTION TUBING
A3 TEST FOR OVERFILL PROTECTION AND COLLECTION CAPACITY
A4 TEST AGAINST SPILLAGE
A5 TEST FOR LEAKAGE FROM THE COLLECTION CONTAINER
A5.1 Collection containers for general use
A5.2 For collection containers for thoracic drainage
A6 TEST FOR NEGATIVE PRESSURE PROTECTION
A7 TEST FOR POSITIVE PRESSURE PROTECTION IN THORACIC DRAINAGE
A8 ANTI-BLOWBACK TEST IN VENTURI-POWERED SUCTION SYSTEMS
A9 TEST OF ‘CF COMPATIBLE’ EQUIPMENT
A10 DROP TEST
A11 TEST FOR VACUUM
A12 TEST FOR PHARYNGEAL SUCTION
A12.1 Test material and apparatus
A12.1.1 Simulated vomitus
A12.1.2 Graduated vessel
A12.2 Procedure
A13 TEST FOR FREE AIRFLOW OF LOW VACUUM EQUIPMENT
A14 TEST FOR THORACIC DRAINAGE
A15 TEST FOR VACUUM REGULATOR WITH A FIXED SETTING
A15.1 Apparatus
A15.2 Procedure
A16 TEST FOR VACUUM REGULATOR WITH A VARIABLE SETTING
