Therapeutic Goods Administration

Site

Laboratories Branch Biomaterials & Engineering – Biomaterials & Engineering

Accreditation No.

2432

Site No.

2425

Date of Accreditation

10 Aug 1988

Address

136 Narrabundah Lane
Symonston, ACT 2609
Australia

tga.gov.au

Contact

Ms Annette Carmichael P: +61 (02) 62893277

Availability

Services conditionally available to external clients

Scope of Accreditation

ISO/IEC 17025 (2017)

Manufactured Goods

Service Product Determinant Technique Procedure
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 

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.