UNI EN ISO 8835-2 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS
30-05-2022
01-01-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
4.1 Materials
4.2 Anaesthetic breathing system component packaging
4.3 Electrical requirements
4.4 Alternative test methods
5 Connection ports
5.1 Patient connection port
5.2 Y-Piece
5.3 Exhaust connection port
5.4 Interchangeable non-rebreathing exhaust valves
5.5 Reservoir bag connection port
5.6 Anaesthetic ventilator connection port
5.7 Connection ports of interchangeable anaesthetic
breathing system components
5.8 Inspiratory and expiratory connection ports of an
interchangeable circle absorber
assembly
5.9 Other connection ports
6 Reservoir bag/anaesthetic ventilator selector switch
7 Complete anaesthetic breathing system either supplied
assembled or assembled in accordance with the
manufacturer's instructions
7.1 Leakage
7.2 Inspiratory and expiratory pressure/flow
characteristics
8 Interchangeable anaesthetic breathing system
components - Exhaust valves
8.1 Direction of movement of controls
8.2 Pressure/flow characteristics
8.3 Opening pressure
8.4 Leakage
9 Circle absorber assemblies
9.1 Construction
9.2 Absorbent bypass mechanism
9.3 Pressure/flow characteristics
9.4 Inspiratory and expiratory valves
10 Pressure monitoring and limitation
10.1 Pressure monitoring
10.2 Pressure-limiting device
11 Location of components in an anaesthetic breathing
system containing a circle absorber assembly (as
defined in 3.3)
11.1 Exhaust valve
11.2 Reservoir bag connection port
11.3 Fresh gas inlet
11.4 Inspiratory and expiratory valves
12 Marking
12.1 Marking of complete anaesthetic breathing systems
and anaesthetic breathing system components
12.2 Marking of packages
13 Information to be provided by the manufacturer or
supplier
13.1 General
13.2 For anaesthetic breathing systems supplied complete
13.3 For anaesthetic breathing system components
Annex A (normative) Typical test arrangements and methods
Annex B (informative) Rationale
Annex C (informative) Environmental aspects
Annex D (normative) Antistatic requirements
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42 EEC
Bibliography
Describes requirements for anaesthetic breathing systems that are supplied either assembled by the manufacturer or for assembly by the user in accordance with the manufacturer's instructions. Also covers circle absorber assemblies, exhaust valves, inspiratory and expiratory valves and, in some designs, those parts of an anaesthetic breathing system that are incorporated within an inhalation anaesthetic system, including the expiratory gas pathway of an anaesthetic ventilator.
DocumentType |
Standard
|
PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
EN ISO 8835-2:2009 | Identical |
ISO 8835-2:2007 | Identical |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
ISO/TS 18835:2004 | Inhalational anaesthesia systems Draw-over vaporizers and associated equipment |
ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
ISO 5362:2006 | Anaesthetic reservoir bags |
ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
IEC 60601-2-13:2003+AMD1:2006 CSV | Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems |
ISO 2878:2017 | Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance |
ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.