ASTM F29
Structure/Work Plan
Updated December 2002
F29 on Anesthetic and Respiratory Equipment
Structure and Work Plan
Chair: Julian Goldman, MD – Mass General Hospital
Phone: 617-726-2450
Email: standards@acmeanesthesia.com
Producer Vice-Chair: Mark Graber – Datex Ohmeda, Inc.
Phone: 608-221-1551, ext. 3528
Email: mark.graber@us.datex-ohmeda.com
User Vice-Chair: John Hedley-Whyte, MD – Harvard University
Phone: 617-327-5563 Email: isohwdrm@hms.harvard.edu
Recording Secretary: D. Ed Supkis, MD
Phone: 713-792-3776 Email: esupkis@mail.mdanderson.org
Membership Secretary: Jerry Dorsch, MD
Phone: 904-264-2039 Email: jdors556@bellsouth.net
WebSite: www.astm.org/COMMIT/F29.htm
SCOPE: The development of terminology, units of measure, identification, dimensions,
tolerances, performance, and test methods of anesthetic and respiratory equipment and systems
for function and safety.
The work of this Committee will be coordinated with other ASTM Committees and other
organizations having mutual interest.
STRUCTURE and WORK PROGRAM
F29.10 on Anesthesia Workstations
Chair: Stanley Weitzner, MD
104 Hampshire Place
Chapel Hill, NC 27516-8748
F29.10 Standards and status
Task Group
Standard
Designation
F29.10.01
Anesthesia Gas
Machines (Weitzner)
F29.10.02
Breathing
Systems/Performance
(Weitzner)
F29.10.03
Connectors and
Adapters (Weitzner)
F29.10.04
Breathing Systems
and Anti-Disconnect
Fittings (Open)
919-684-2425
FAX: 919-681-7425
Email: weitz001@mc.duke.edu
Title
Status
ISO
Relationship
ISO/TC121/SC1
F1208-89(2000)
Specification for Minimum
Performance and Safety
Requirements for
Anesthesia Breathing
Systems
Current
ISO/TC121/SC1
F1054-01
Specification for Conical
Fittings of 15-mm and 22mm sizes
Current
ISO/TC121/SC1
ISO/TC121/SC1
PAGE 1
ASTM F29
Structure/Work Plan
Updated December 2002
F29.10 Standards and status (Continued)
Task Group
Standard
Designation
F29.10.05
Anesthesia Gas
Scavenging Systems
(AGSS) (Weitzner)
F29.10.06
Lung Ventilators for
Use in Anesthesia
(Weitzner)
F29.10.07
Anesthesia
Workstations
(Weitzner)
F1343-02
F1101-90(1996)
F1850-00
Title
Specification for
Anesthetic Equipment –
Scavenging Systems for
Anesthetic Gases
Specification for
Ventilators Intended for
Use During Anesthesia
Current
ISO
Relationship
ISO/TC121/SC1
Requires
review
ISO/TC121/SC1
ISO/IEC JWG1
Specification for Particular
Requirements for
Anesthesia Workstations
and Their Components
Current
ISO/TC121/SC 1
IEC/SC62D
F29.11 on Gas Monitors
Chair: D. Ed Supkis, MD
303 Timber Terrace Rd.
Box 42
Houston, TX 77024
F29.11 Standards and status
Task Group
Standard
Designation
F29.11.01
Capnographs and
Anesthetic Agent
Analyzers (Supkis)
F29.11.02
Nitric Oxide Delivery
Devices and Monitors
(Supkis)
713-792-3776
Email: esupkis@mail.mdanderson.org
Title
Status
F1452-01
Specification for Anesthetic
Agent Monitors
Current
F1456-01
Specification for
Capnometers
Specification for Particular
Requirements for Nitric
Oxide Monitors
Current
F2185
Intended for ISO
ISO
Relationship
ISO/TC121/SC1/
WG5
Intended for ISO
Intended for ISO
F2186
Intended for ISO
F29.11.03
Cutaneous Gas
Monitoriing (Supkis)
(TG has been
disbanded)
F29.11.04
Oxygen Analyzers
(Hedley-Whyte)
Status
Spec…. Nitrogen Dioxide
Monitors
F1462-93
(Withdrawn)
Specification for Oxygen
Analyzers
ISO 7767
Oxygen Monitors for
Monitoring Patient
Breathing Mixtures-Safety
Req
PAGE 2
Withdrawn –
Replaced with
Adoption of ISO
7767
Adopted w/
Deviations
ISO/TC121/SC1
WG5
ASTM F29
Structure/Work Plan
Updated December 2002
F29.11 on Gas Monitors (Continued)
F29.11.05
Pulse Oximeters
(Weitzner)
F1415-92(2000)
Specification for Pulse
Oximeters
Current
ISO/TC121/SC3
WG4
F29.12 on Airways
Chair: Fran Catlin, MD
713-461-2221
American Academy of Otolaryngology
FAX: 713-467-4087
13307 Queensbury Lane
Email: fcat@airmail.net
Houston, TX 77079-6013
Acting Chair – Ann Graham – See Contact information- same as F29.13
F29.12 Standards and status
Task Group
Standard
Designation
Title
Status
ISO
Relationship
ISO/TC121/SC2
Specification for Cuffed
and Uncuffed Tracheal
Tubes
Withdrawn –
Replaced with
ISO 5361
Specification for Tracheal
Tube Connectors
Withdrawn –
Replaced with
ISO 5361
ISO 5361 – Adopted
no deviations
Anaesthetic and Resp
Equip –Tracheal Tubes
and Connections
ISO 5361 –
Adopted no
deviations
F29.12.02
Naso/Oropharyngeal
Airways
F1573-95(2000)
Current
ISO/TC121/SC2
F29.12.03
BreathingTubes/Bags
F1204-88(1998)
(Withdrawn)
Specification for Anesthetic
Equipment –
Oropharyngeal and
Nasopharyngeal Airways
Specification for
Anesthesia Reservoir Bags
Withdrawn,
replaced with
ISO 5362
ISO/TC121/SC2
F29.12.01
Tracheal Tubes
F1242-96
(Withdrawn)
F1243-89(1995)
(Withdrawn)
F29.12.04
Tracheostomy Tubes
- Adult
ISO 5362 – Adopted
no deviaitons
Anesthesia Reservoir Bags
F1205-88(1999)
Specification for
Anesthesia Breathing
Tubes
Specification for
Tracheostomy Tube
Connectors
F1590-95
Adopted, no
deviations
F1666-95E1
Specification for Adult
Tracheostomy Tubes
F29.12.05
Tracheostomy Tubes
– Pediatric
F1627-95
F29.12.06
Suction Catheters
F1981-99
Specification for
Tracheostomy Tubes –
Pediatric Tracheostomy
Tubes
Specification for Suction
Catheters for Use in the
Respiratory Tract
F29.13 on Laryngoscopes and Bronchoscopes
Acting Chair Ann Graham
US FDA
1350 Piccard Dr.
Rockville, MD 0850
PAGE 3
Current
Requires
action
ISO/TC121/SC2
Requires
action
Requires
action
ISO/TC121/SC2
Current
ISO/TC121/SC2
301-594-1555
FAX: 301-594-1967
Email: aag@cdrh.fda.gov
ASTM F29
Structure/Work Plan
Updated December 2002
F29.13 Standards and status (Continued)
Task Group
Standard
Designation
F29.13.01
Laryngoscopes –
Bulbs/Handles/
Blades (Rigid)
F29.13.02
Laryngoscopes and
Bronchoscopes
(Flexible)
F12.13.03
Bronchoscopes
(Rigid)
Title
Specification for Rigid
Laryngoscopes for
Tracheal Intubation –
Hook-on Fittings for
Laryngoscope Handles
and Blades with Lamps
Current
F1195-99
Specification for Rigid
Laryngoscopes for
Tracheal Intubation –
Hook-on Fittings for Fiberilluminated Blades and
Handles
Specification for Flexible
Fiberoptic Bronchoscopes
Current
(Withdrawn – no
replacement
ISO/TC121/SC2
Specification for
Bronchoscopes Rigid
Current
ISO/TC121/SC2
F896-90(1999)
(Withdrawn)
F1218-89(1999)
F29.14 Standards and status
Task Group
Standard
Designation
F29.14.02
Gas Mixers (HedleyWhyte)
F29.14.03
Humidifiers
(Carstensen)
ISO
Relationship
ISO/TC121/SC2
F965-99
F29.14 on Ventilators
Chair: John Hedley-Whyte, MD
Harvard University
1400 VFW Parkway
Boston, MA 02132-4927
F29.14.01
Lung Ventilators
(Other than for
Anesthesia) (HedleyWhyte)
Status
F1100-90(1997)
Adopt IEC/ISO
60601-2-12
617-327-5563
FAX: 617-327-5563
Email: isohwdrm@hms.harvard.edu
Title
Status
Specification for Ventilators
Intended for Use in Critical
Care
Med Elec Equip 2-12 Part
req for the Safety of Lung
Vent – Critical Care Vent
Action Required
Adopted w/
Deviations
ISO
Relationship
ISO/IEC JWG
ISO/TC121/SC3
and
IEC/SC62D
ISO/TC121/SC3
F1690-96
F29.14.04
Home Care
Ventilators
(Hedley-Whyte)
F1246-91(1999)
F29.14.05
Oxygen
Concentrators
(Hedley-Whyte)
F29.14.06
Resuscitators
(Hedley-Whyte)
F1464-93(1999)
F920-93(1999)
Specification for
Humidifiers for Medical
Use – Part 1: General
Requirements for Active
Humidification Systems
Specification for
Electrically Powered Home
Care Ventilators, Part 1:
Positive-Pressure
Ventilators and Ventilator
Circuits
Specification for Oxygen
Concentrators for
Domiciliary Use
Action required
ISO/TC121/SC3
Current
ISO/TC121/SC3
Current
ISO/TC121/SC3
Specification for Minimum
Performance and Safety
Requirements for
Resuscitators Intended for
Use with Humans
Current
ISO/TC 121/SC3
PAGE 4
ASTM F29
Structure/Work Plan
Updated December 2002
F29.15 on Harmonization of Alarms
Chair: John Hedley-Whyte, MD
Harvard University
1400 VFW Parkway
Boston, MA 02132-4927
F29.15 Standards and status
Task Group
Standard
Designation
F29.15.01
Harmonization of
Alarms (HedleyWhyte)
F1463-93(1999)
617-327-5563
FAX: 617-327-5563
Email: isohwdrm@hms.harvard.edu
Title
Status
Specification for Alarm
Signals in Medical
Equipment Used in
Anesthesia and
Respiratory Care
Current
F29.16 on Terminology
Chair: Jerry Dorsch, MD
Holly Point E
Orange Park, FL 32073
F29.16 Standards and status
Task Group
Standard
Designation
F29.16
Terminology
(Dorsch)
F2002-01C
(Withdrawn)
ISO 4135
Adopted w/
Deviations
904-264-2039
FAX: 904-215-7714
Email: jdors556@bellsouth.net
Title
F29.17.01
Medical Surgical
Suction and Drainage
(Blackert)
Status
Terminology Relating to
Anesthesia and
Respiratory Equipment
Withdrawn –
Replaced with
ISO 4135
Anesthesia and
Respiratory Equipment Vocabulary
Adopt ISO
Standard w/
Deviations
F29.17 on Medical Surgical Suction and Drainage
Chair: Karen Blackert
Ohmeda Medical
9065 Guilford Road
Columbia, MD 21046
F29.17 Standards and status
Task Group
Standard
Designation
ISO
Relationship
ISO/IEC JWG
ISO/TC121/SC3
and
IEC/SC62A
410-381-2555 X4150
FAX: 410-381-2558
Email: blackert@ohmedamedical.com
Title
Status
F960-86(2000)
Specification for Medical
and Surgical Suction and
Drainage Systems
Ballot to
Withdraw
ISO 10079-1-3
Medical Suction Equip
Parts 1, 2, 3
Ballot to Adopt
with deviations
PAGE 5
ISO
Relationship
ISO/TC121/SC4
ISO
Relationship
ISO/TC121/SC8
ASTM F29
Structure/Work Plan
Updated December 2002
F29.18 on Operating Room Fire Safety
Chair: Gerry Wolf, MD
New York State University
Department of Anesthesiology
450 Clarkson Avenue, P.O. Box 6
Brooklyn, NY 11203
F29.18 Standards and status
Task Group
Standard
Designation
718-270-2677
FAX: 718-270-3928
Email: gwolf@hscbklyn.edu
Title
Status
ISO Relationship
F29.18.01
OR Fire Safety
(Wolf)
Z8255z
Guide to Surgical Fires:
Decided not to
Pursue as a
standard
ISO/TC172/SC9/
WG4
F29.18.02
Tracheal Tubes for
Laser Surgery (Wolf)
F1497-99A
Test Method for
Determining Laser
Resistance of the Shaft of
Tracheal Tubes
Current
ISO/TC172/SC9/
WG42 and
ISO/TC121/SC92/
WG2
F1628-95(2000)
Specification for Labeling
and Marking of Cuffed and
Uncuffed Tracheal Tubes
and Related Treatments
Intended for Use During
Laser Surgery
F29.19 on Warming Devices
Acting Chair: Robert Virag
Trifid Medical LLC
14337 Cypress Hill Dr.
Chesterfield, MO 63017
F29.19 Standards and status
Task Group
Standard
Designation
F29.19.01
Patient Warming
Equipment –
Warming Blankets
(Virag)
F29.19.02
Patient Warming
Equipment – Blood
and Fluid Warmers
(Virag)
Current
314-878-4620
FAX: 309-2181129
Email:rvirag@trifidmedical.com
Title
F2196-02
Spec for Circulating Liquid
and Forced Air Patient
Temp Man Devices
F2172-02
Spec for Blood and Fluid
IV / Irrigation Fluid
Warmers
PAGE 6
Status
Intended for
IEC/ISO Use
Intended for
IEC/ISO Use
ISO
Relationship
IEC SC62D
ASTM F29
Structure/Work Plan
Updated December 2002
Summary of Actions Regarding Adoption/Withdrawal/ ISO Intended
Adoption of ISO Standards
Adoption of ISO 7767Oxygen Monitors for Monitoring Patient Breathing Mixtures-Safety ReqWith Deviations (.11)
Adoption of ISO 5361 Anaesthetic and Resp Equip –Tracheal Tubes and Connections – No
Deviations (.12)
Adoption of ISO 5362 Anesthesia Reservoir Bags – No Deviations (.12)
Adoption of IEC/ISO 60601-2-12 Med Elec Equip 2-12 Part Requirements for the Safety of Lung
Vent – Critical Care Vent - With Deviations (.14)
Adoption of ISO 4135 Anesthesia and Respiratory Equipment Vocabulary – With Deviation (.16)
Adoption of ISO 10079 Parts 1,2,and 3 Medical Suction Equipment – With Deviation (.17) Being
Balloted
Withdrawn
F1462-93, Replaced with ISO 7767(.11)
F1242-96, Replaced with ISO 5361 (.12)
F1243-89(1995), Replaced with ISO 5361 (.12)
F1204-88(1998), Replaced with ISO 5362 (.12)
F896-89(1999), No replacement (.13)
F2002-01C, Replaced with ISO 4135 (.16)
F960 – Being Balloted , Replace with ISO 10079-1-3 (.17)
Intended for ISO/IEC Use
F2185 – Specification for Particular Requirements for Nitric Oxide Monitors (.11)
F2186 – Specification for Particular Requirements for Nitrogen Dioxide Monitors (.11)
F2196-02 - Spec for Circulating Liquid and Forced Air Patient Temp Man Devices (.19)
F2172-02 - Spec for Blood and Fluid IV / Irrigation Fluid Warmers (.19)
PAGE 7