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TGC meeting 21, 11 February 2003

Therapeutic Goods Committee

11 February 2003

Meeting report

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TGC 21st meeting (11 February 2003) report (pdf,53kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 21st Meeting held on 11 February 2003. It should not be assumed that recommendations made by the TGC to the TGA represent the decisions of the TGA. Reasons underlying the TGC Resolutions will be available in the form of an edited Report following ratification of the Minutes by the Committee.

Adoption of British Pharmacopoeia 2002

The Therapeutic Goods Committee recommends the adoption of the British Pharmacopoeia 2002 on 1 April 2003 for the purposes of the edition of the British Pharmacopoeia defined under the Therapeutic Goods Act 1989.

The Therapeutic Goods Committee recommends that Therapeutic Goods Order No. 70 Standards for Export Only Medicine be amended to replace the reference to British Pharmacopoeia 2001 with reference to British Pharmacopoeia 2002 with effect 1 April 2003.

Child-resistant packaging

The Therapeutic Goods Committee:

  • Endorses the amended draft Therapeutic Goods Order No. 65 Child-resistant packaging for therapeutic goods; and
  • Recommends the gazettal of this Therapeutic Goods Order as a standard for therapeutic goods made under section 10 of the Therapeutic Goods Act 1989.

Limits for content of minerals in tablets and capsules specified in Therapeutic Goods Order No. 56

The Therapeutic Goods Committee recommends the following approach be taken by the TGA when considering requests for exemption from the requirements of Therapeutic Goods Order No. 56 General standard for tablets, pills and capsules relating to content limits for minerals contained in multi-mineral and multi-mineral/multivitamin products:

  • The permissible limits should be those of the current United States Pharmacopeia (USP) except for those elements which are subject to a Schedule in the Standard for the Uniform Scheduling of Drugs and Poisons;
  • For those elements subject to a Schedule in the Standard for the Uniform Scheduling of Drugs and Poisons:
    • The USP limits should only apply to those products stated to contain no more than 50 per cent of the scheduled amount;
    • In all other cases, the limits that apply should be no less than 90 per cent and no more than 125 per cent of the stated content.

The Therapeutic Goods Committee recommends that:

  • At its next Meeting, a Subcommittee be established to review Therapeutic Goods Order No. 56 General standard for tablets, pills and capsules (TGO 56) and associated matters; and
  • Before that Meeting, the TGA should canvass stakeholders in order to identify issues for consideration in the review of TGO 56.

Medicine labelling - TGA labelling review and performance based labelling

The Therapeutic Goods Committee gives in-principle support to:

  • The linking of Therapeutic Goods Order No. 69 General requirements for labels for medicines to the TGA's proposed document Required Advisory Statements for Therapeutic Goods; and
  • The proposal to add a statement on the principles of labelling of non-prescription medicines to Therapeutic Goods Order No. 69 General requirements for labels for medicines with a reference to the Industry Code of Practice Designing medicine labels for people to be included in the Supplementary Notes to the Order.

Standards for haematopoietic stem cell (HSC) products

The Therapeutic Goods Committee establishes an ad hoc Working Party to be chaired by Associate Professor William Rawlinson to:

  • Consider the adoption of the 2nd edition of International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release [NETCORD and Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) (July 2001)] as the basis of a Therapeutic Goods Order for Haemopoietic Stem Cells Harvested from Placental Cord Blood;
  • Consider the adoption of the 2nd edition of Standards for Hematopoietic Progenitor Cell Collection, Processing & Transplantation [Foundation for the Accreditation of Cellular Therapy (FACT) (2002)] as the basis of a Therapeutic Goods Order for Haemopoetic Stem Cells Harvested from Sources Other than Placental Cord Blood; and
  • Provide a report for consideration at the next Meeting of the Therapeutic Goods Committee.

New medical devices legislation

The Therapeutic Goods Committee notes:

Therapeutic Goods Orders relating to therapeutic devices

The Therapeutic Goods Committee notes the gazettal of Therapeutic Goods Order No 67A Amendment to Therapeutic Goods Order No. 67 - Standard for Dental Materials.

Review of the code of good wholesaling practice for therapeutic goods for human use

  • The Therapeutic Goods Committee establishes an ad hoc Working Party to be chaired by Professor Stella O'Donnell in order to further develop a revised code for the distribution of therapeutic goods and report to the next Meeting of the Committee.
  • The Working Party is to have appropriate representation from relevant stakeholders.

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Attachment 1: Medical device/conformity assessment standards proposed for gazettal

Medical Device/Conformity Assessment Standard
AS EN 556.1-2002
identical to:
EN 556-1: 2001
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 868-1: 1997
Packaging materials and systems for medical devices which are to be sterilized - Part 1:general requirements and test methods
OR
ISO 11607:
1997 Packaging for terminally sterilized medical devices
AS ISO 11135-2002
Identical to:
ISO 11135: 1995
Medical devices - Validation and routine control of ethylene oxide sterilization
OR
EN 550: 1994
Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization
AS ISO 11137-2002
identical to:
ISO 11137: 1995
Sterilization of health care products -Requirements for validation and routine control - Radiation sterilization
OR
EN 552: 1994
Sterilization of medical devices - Validation and routine control of sterilization by irradiation
ISO 11134: 1994
Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
OR
EN 554: 1994
Sterilization of medical devices - Validation and routine control of sterilization by moist heat
AS ISO 14160-2002
identical to:
EN ISO 14160: 1998
identical to:
ISO 14160: 1998
Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants
AS EN 540-2002
identical to:
EN 540: 1993
Clinical investigation of medical devices for human subjects
OR
AS ISO 14155-2002
identical to:
ISO 14155:1996
Clinical investigation of medical devices
ISO 5840:1996
Cardiovascular implants - Cardiac valve prostheses
ISO 11979-7:2001
Ophthalmic implants - Intraocular lenses -- Part 7: Clinical investigations
EN ISO 14971:2002
identical to:
ISO 14971:2000
Medical Devices - Application of Risk Management to Medical Devices
EN 12442-1: 2000
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk
EN 12442-2: 2000
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling
EN 12442-3: 2000
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents
AS ISO 13485: 2002
identical to:
ISO 13485:1996
Quality systems - Medical devices - Particular requirements for the application of ISO 9001
AS ISO 13488: 2002
identical to:
ISO 13488:1996
Quality systems - Medical devices - Particular requirements for the application of ISO 9002
EN 46003: 1999
Quality systems - Medical devices - Particular requirements for the application of ISO 9003
OR
AS ISO 13488: 2002
identical to:
ISO 13488:1996
Quality systems - Medical devices - Particular requirements for the application of ISO 9002
Excluding Clause: 4.9 Process Control
AS ISO 9703.1:2002
identical to:
ISO 9703-1: 1992
Anaesthesia and Respiratory Care Alarm Signals Part 1 : Visual Alarms Signals
AS ISO 9703.2: 2002
identical to:
ISO 9703-2: 1994
Anaesthesia and Respiratory Care Alarm Signals Part 2 : Auditory Alarms Signals

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Attachment 2: Medical device/conformity assessment standards not recommended for adoption

These standards are not being adopted either because they are outside the scope of the new medical device legislation or because they are superseded.

Standard
reference
Title Reason for exclusion
EN 738-2 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation.
EN 737-4 Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation.
EN 737-3 Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation.
EN 737-2 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - basic requirements This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation.
EN 737-1 Medical gas pipeline systems - Part 1: terminal units for compressed medical gases and vacuum This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation.
AS 2896-1998 Medical gas systems - Installation and testing of non-flammable medical gas pipeline systems This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation.
EN 285 Sterilization - steam sterilizers - large sterilizers This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation.
AS 1410: 1987 Sterilizers - Steam - Pre-vacuum This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation.
AS 2192: 2002 Sterilizers - Steam - Downward displacement This equipment is considered a building fixed installation and is not considered within the scope of the new device legislation.
EN 13220 Flow-metering devices for connection to terminal units of medical gas pipeline systems Under consideration
AS 4484-1997 Industrial, medical and refrigerant compressed gas cylinder identification Bottled medical gases are classified as drugs and hence marking and labelling is not considered within the scope of the new device legislation.
EN ISO 4135 ISO 4135 is Vocabulary for Anaesthesia
Incorrect description was quoted - To be resolved
Guideline document only - does not set requirements.
EN 1441 Medical devices - risk analysis superseded
EN 1174-3 Sterilization of medical devices - Estimation of the population of microorganisms on product - Part 3: Guide to the methods for validation of microbiological techniques Identified to be outside the scope of the sterility order .
EN 1174-2 Sterilization of medical devices - Estimation of the population of microorganisms on product - Part 2: Guidance Identified to be outside the scope of the sterility order .
EN 1174-1 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements Identified to be outside the scope of the sterility order.
AS 1079.1-1993 Packaging of items (sterile) for patient care - Selection of packaging materials for goods undergoing sterilization These documents set requirements to be applied by the terminal user but not by the manufacturer. Hence they are considered outside the scope of the new device legislation.
AS 1079.2-1994 Packaging of items (sterile) for patient care - Non-reusable papers - For the wrapping of goods undergoing sterilization in health care facilities These documents set requirements to be applied by the terminal user but not by the manufacturer. Hence they are considered outside the scope of the new device legislation.
AS 1079.3-1994 Packaging of items (sterile) for patient care - Paper bags - For single use in health care facilities These documents set requirements to be applied by the terminal user but not by the manufacturer. Hence they are considered outside the scope of the new device legislation.
AS 1079.4-1988 Packaging of items (sterile) for patient care - Flexible packaging systems - For single use in hospitals These documents set requirements to be applied by the terminal user but not by the manufacturer. Hence they are considered outside the scope of the new device legislation.
AS 1079.5-1994 Packaging of items (sterile) for patient care - Non-reusable, non-woven wrapping materials - For goods undergoing sterilization in health care facilities These documents set requirements to be applied by the terminal user but not by the manufacturer. Hence they are considered outside the scope of the new device legislation.
EN 738-4 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment These are considered spare parts, not medical devices.
EN 724 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices The European standard EN46000 is now superseded by ISO 13485. The guidance documents are superseded.
EN 50103 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry The European standard EN46000 is now superseded by ISO 13485. The guidance documents are superseded.

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Attachment 3: Medical device/conformity assessment standards under consideration

Standard reference Title Comments
EN 45502-1 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer  
EN 1280-1 Agent specific filling systems for anaesthetic vaporizers - Part 1: rectangular keyed filling systems  
AS/NZS 3200.1.4:1997 All available Part 2 - Particular Standards  
AS/NZS 4535:1999 Ambulance restraint systems  
ISO 5356-1: 1996 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets  
EN 1281-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: cones and sockets  
EN 1281-2 Anaesthetic and respiratory equipment - Conical connectors - Part 2: screw-threaded weight bearing connectors  
ISO 5366-3: 2001 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 3: Paediatric tracheostomy tubes  
ISO 5356-2: 1987 Anaesthetic and respiratory equipment; Conical connectors; Part 2 : Screw-threaded weight-bearing connectors  
ISO 11196:1995 Anaesthetic gas monitors
and Technical Corrigendum 1:1997
 
ISO 5362:2000 Anaesthetic reservoir bags  
ISO 5360: 1993 Anaesthetic vaporizers; agent-specific filling systems  
IEC 60645-2:1993 Audiometers - Part 2: Equipment for speech audiometry  
IEC 60645-3:1994 Audiometers - Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes  
IEC 60645-4:1994 Audiometers - Part 4: Equipment for extended high-frequency audiometry  
AS ISO 10993.1-2002 Biological evaluation of medical devices - Part 1: Evaluation and testing EN ISO 10993-1
AS ISO 10993.11-2002 Biological evaluation of medical devices - Part 11 :Tests for systematic toxicity ISO 10993-11:1993
AS ISO 10993.3-2002 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-3:1992
AS ISO 10993.4-2002 Biological evaluation of medical devices - Part 4 ISO 10993-4:1992
AS ISO 10993.5-2002 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-5:1992
AS ISO 10993.6-2002 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation ISO 10993-6:1994
AS ISO 10993.9-2002 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products EN ISO 10993-9
AS ISO 10993.10-2002 Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization EN ISO 10993-10
AS ISO 10993.12-2002 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials EN ISO 10993-12
AS ISO 10993.13-2002 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices EN ISO 10993-13
AS ISO 10993.16-2002 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables EN ISO 10993-16
AS/NZS 2496: 1995 Breathing attachments for anaesthetic purposes for human use  
ISO 5367: 2000 Breathing tubes intended for use with anaesthetic apparatus and ventilators  
ISO 9918: 1993 Capnometers for use with humans; requirements  
EN 1618 Catheters other than intravascular catheters - test methods for common properties  
AS 2190-1995 Clinical maximum thermometers - mercury-in glass  
EN 12470-3 Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device  
EN 20594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: general requirements  
AS EN 1642-2002 Dentistry - Medical devices for dentistry - Dental implants  
AS EN 1640-2002 Dentistry - Medical devices for dentistry - Equipment  
AS EN 1641-2002 Dentistry - medical devices for dentistry - Materials  
IEC 60645-1:2001 Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers  
AS ISO 10535-2002 Hoists for the transfer of disabled persons - Requirements and test methods  
EN ISO 8185 Humidifiers for medical use - general requirements for humidification systems  
EN 1819 Laryngoscopes for tracheal intubation - particular requirements  
AS ISO 7376.1-2002 Laryngoscopic fittings - Part 1: Conventional hook-on type handle blade fittings  
AS ISO 7376.2-2002 Laryngoscopic fittings - Part 2: Miniature electric lamps - Screw threads and sockets for conventional blades  
AS ISO 7376.3-2002 Laryngoscopic fittings - Part 3: Fibre-illuminated re-usable rigid laryngoscopes  
EN 739 Low pressure hose assemblies for use with medical gases  
ISO 10651-4: 2002 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators  
ISO 10651-2: 1996 Lung ventilators for medical use - Part 2: Particular requirements for home care ventilators  
ISO 10651-3: 1997 Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators  
ISO 10651-1: 1993 Lung ventilators for medical use; part 1: requirements  
AS/NZS 3200.1.0:1998 Medical electrical equipment. Part 1: General requirements for safety  
AS/NZS 3200.1.1:1995 +
Amendment 1
Medical electrical equipment. Part 1: General requirements for safety - 1. Collateral standard: safety requirements for medical electrical systems  
AS/NZS 3200.1.2:1995 Medical electrical equipment. Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - requirements and tests  
AS/NZS 3200.1.3:1996 Medical electrical equipment. Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment  
AS/NZS 3200.1.4:1997 Medical electrical equipment. Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems  
AS 1600.1-1988 Medical equipment - Conical fittings with a 6 percent (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements  
AS 2120.1: 1992 Medical suction equipment - Part 1: electrically powered suction equipment - safety requirements  
AS 2120.2: 1992 Medical suction equipment - Part 2: manually powered suction equipment  
AS 2120.3: 1992 Medical suction equipment - Part 3: suction equipment powered from vacuum or pressure source  
AS EN 1060.1-2002 Non-invasive sphygmo-manometers - Part 1: general requirement  
AS EN 1060.2-2002 Non-invasive sphygmo-manometers - Part 2: supplementary require-ments for mechanical Sphygomomanometers  
EN 1089-3 Non-invasive sphygmo-manometers - Part 3: Supplementary requirements for electromechanical blood pressure measuring systems  
AS/NZS ISO 15004: 2002 Ophthalmic instruments - Fundamental requirements and test methods  
AS/NZS ISO 11990: 2002 Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts  
EN ISO 8359 Oxygen concentrators for medical use - safety requirements AS 3200.2.200-1992
ISO 7767:1997 Oxygen monitors for monitoring patient breathing mixtures - Safety requirements  
AS/NZS 2696:1996 Polymer Urethral CathetersEN 738-3 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves  
ISO 9919: 1992 Pulse oximeters for medical use - Requirements EN 12218 Rail systems for supporting medical equipment  
AS/NZS 4179: 1997 Single-use sterile surgical rubber gloves - Specification based on TGO 53
AS ISO 10555.1-2002 Sterile, single-use intravascular catheters - Part 1: General requirements  
EN 12182 Technical aids for disabled persons - general requirements and test methods  
EN 1282-2 Tracheostomy tubes - Part 2: paediatric tubes  
AS 3693-1989 Wheelchairs - Nomenclature, terms and definitions  
AS 3696.1-1990 Wheelchairs - Part 1: Determination of static stability  
AS 3696.10-1990 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electric wheelchairs  
AS 3696.11-1993 Wheelchairs - Part 11: Test dummies  
AS 3696.13-1991 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces  
AS/NZS 3696.14:1998 Wheelchairs - Part 14: Power and control systems for electric wheelchairs - Requirements and test methods  
AS 3696.2-1992 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs  
AS 3696.3-1990 Wheelchairs - Part 3: Determination of efficiency of brakes  
AS 3696.4-1992 Wheelchairs - Part 4: Determination of energy consumption of electric wheelchairs  
AS 3696.5-1989 Wheelchairs - Part 5: Determination of overall dimensions, mass and turning space  
AS 3696.6-1990 Wheelchairs - Part 6: Determination of maximum speed, acceleration and retardation of electric wheelchairs  
AS/NZS 3696.8:1998 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths  
AS 3696.9-1990 Wheelchairs - Part 9: Climatic tests for electric wheelchairs  
AS 3695-1992 Wheelchairs - Product requirements  

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