Australia National Pathology Standards (First Edition 2027)
Standard 8: Medical devices – Australia National Pathology Standards (First Edition 2027)

Australia National Pathology Standards (First Edition 2027) 8.02: Medical device use: use devices for their intended purpose per the manufacturer's instructions for use, classify commercial IVDs used outside their intended purpose (such as unspecified specimen types) as in-house IVDs, and comply with the relevant NPAAC standards and TGA requirements

What does 8.02 require?

Devices are operated as the manufacturer intended and as the instructions for use say. A commercial IVD pressed into a use its instructions do not cover, such as a specimen type not listed, becomes an in-house IVD and carries the validation and regulatory duties that follow; and the relevant NPAAC requirements and TGA rules are met.

Maintained by Gerard Blokdyk

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This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence · 1 control

  • 6.4.4 6.4.4 Equipment instructions for use

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Standard 8: Medical devices – Australia National Pathology Standards (First Edition 2027)

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The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll Australia National Pathology Standards (First Edition 2027) controls