Therapeutic Goods Administration

Site

Laboratories Branch Biomaterials & Engineering – Biomaterials & Engineering

Accreditation No.

2432

Site No.

2425

Date of Accreditation

10 Aug 1988

Address

1 Tindal Lane
Canberra Airport, ACT 2609
Australia

tga.gov.au

Contact

Ms Erin Fitzgerald P: +61 (02) 62894107

Availability

Services conditionally available to external clients

Scope of Accreditation

Print scopes
Laboratories Branch Biomaterials & Engineering – Biomaterials & Engineering

ISO/IEC 17025 (2017)

Manufactured Goods

Service Product Determinant Technique Procedure Limitations
Performance evaluation of healthcare equipment and related items Examination gloves Dimensions; Evaluation of consumer information - Labelling and markings; Leakage; Tensile properties; Visual examination Not applicable AS/NZS 4011.1 Parts 6.1, 6.2, 6.3 and 8,
 AS/NZS 4011.2 Parts 6.1, 6.2, 6.3 and 8
Male condoms Burst pressure; Burst volume; Evaluation of consumer information - Labelling and markings; Freedom from holes; Leakage; Length; Package integrity; Thickness; Total lubricant; Visible defects; Width Not applicable

ISO 4074 Annexes A, C, D, E, F, H, I, M and N
Performance evaluation of personal protective equipment (PPE) Medical face masks Synthetic blood penetration Not applicable ISO 22609, in-house method BIOME - SOP - Medical Face Masks - Resistance against penetration by synthetic blood 
 Single use face masks (including Target Plate method)

ISO/IEC 17025 (2017)

Materials

Service Product Determinant Technique Procedure Limitations
Chemical analysis of reagents, salts and related compounds Synthetic blood Surface tension Tensiometry ASTM D1331 Method A,
ISO 304

 For the purposes of determining compliance with ISO 22609 Annex B

The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.

Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.