ISO 8835-4:2004
Withdrawn
View Superseded by
Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices
Hardcopy , PDF
English, French
06-03-2004
11-02-2025
For the purposes of ISO 8835-4:2004, the requirements in IEC 60601-1:1988, Clause 1 apply except as follows.
Addition:
ISO 8835-4:2004 specifies particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs), as defined in 3.1. ISO 8835-4:2004 is applicable to AVDDs which are a component of an anaesthetic system and are intended to be continuously operator-attended. ISO 8835-4:2004 gives specific requirements for AVDDs which are supplementary to the applicable general requirements in IEC 60601-2-13.
ISO 8835-4:2004 is not applicable to AVDDs intended for use with flammable anaesthetics, as determined by Annex CC, and AVDDs intended for use within anaesthetic breathing systems (e.g. draw-over vaporizers).
The requirements of ISO 8835-4:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.
| Committee |
ISO/TC 121/SC 1
|
| DevelopmentNote |
Supersedes ISO/DIS 8835-4 (06/2004)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| NF EN ISO 8835-4 : 2009 | Identical |
| NBN EN ISO 8835-4 : 2009 | Identical |
| NEN EN ISO 8835-4 : 2009 | Identical |
| NS EN ISO 8835-4 : 2009 | Identical |
| I.S. EN ISO 8835-4:2009 | Identical |
| PN EN ISO 8835-4 : 2009 | Identical |
| BS EN ISO 8835-4:2009 | Identical |
| EN ISO 8835-4:2009 | Identical |
| DIN EN ISO 8835-4:2009-07 | Identical |
| BS EN ISO 8835-4:2004 | Equivalent |
| I.S. EN ISO 8835-4:2004 | Equivalent |
| UNE-EN ISO 8835-4:2009 | Identical |
| UNE-EN ISO 8835-4:2005 | Identical |
| BS EN ISO 8835-4:2004 | Identical |
| DD ISO/TS 18835:2004 | Inhalational anaesthesia systems. Draw-over vaporizers and associated equipment |
| BS EN 13976-1:2011 | Rescue systems. Transportation of incubators Interface conditions |
| I.S. EN 60601-2-13:2006 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS |
| NF EN 60601 2-13 : 2007 AMD 1 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS |
| EN 13976-1:2011 | Rescue systems - Transportation of incubators - Part 1: Interface conditions |
| 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/TS 18835:2004 | Inhalational anaesthesia systems — Draw-over vaporizers and associated equipment |
| DIN EN 13976-1:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| CEI EN 60601-2-13 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS |
| I.S. EN 13976-1:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| DIN EN 13976-1:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS |
| UNE-EN 13976-1:2011 | Rescue systems - Transportation of incubators - Part 1: Interface conditions |
| ISO 5360:2016 | Anaesthetic vaporizers — Agent-specific filling systems |
| ISO 8835-3:2007 | Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems |
| 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 |
| BS 5252:1976 | Framework for colour co-ordination for building purposes |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets |
| 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 |
| IEC 60079-11:2011 | Explosive atmospheres - Part 11: Equipment protection by intrinsic safety "i" |
| 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 |
| NFPA 53M : 1990 | FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES |
| ISO 4135:2001 | Anaesthetic and respiratory equipment — Vocabulary |
| FED-STD-595 Revision C:2008 | Colors Used in Government Procurement (S/S By SAE-AMS-STD-595) |
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