National Association of Testing Authorities, Australia
Scope of Accreditation
Therapeutic Goods Administration
Site
Laboratories Branch Biomaterials & Engineering – Biomaterials & Engineering
Accreditation No.
2432
Site No.
2425
Date of Accreditation
10 Aug 1988
Contact
Ms Erin Fitzgerald P: +61 (02) 62894107
Availability
Services conditionally available to external clients
Scope of Accreditation
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.
Accreditation No.
2432
Site No.
2425
Print date
02 Nov 2024
END OF SCOPE