MDSAP Audit Approach (MDSAP AU P0002)
Chapter 6: Production and service controls – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C6-T9: Validate and periodically revalidate sterilisation and sterile barrier processes, manufacture sterile devices under controlled conditions and keep batch-traceable sterilisation records

What does C6-T9 require?

Where product is supplied sterile, the sterilisation process must be validated and periodically revalidated with records available, devices must be made and sterilised under suitably controlled conditions, and sterilisation process parameters and results must be documented and traceable to each batch. Australia: validation methods must reflect the state of the art, for example the Medical Device Standards Order on endotoxin requirements and the Conformity Assessment Standards Order referencing ISO 11135, ISO 11137 and related standards (EP 2(1)). Clauses: ISO 13485:2016 4.2.1, 7.5.5, 7.5.6, 7.5.7; TG(MD)R Sch 1 EP 2(1) and 8.3; CMDR 17; RDC 665/2022 Arts 83, 103 to 106; MO169 Arts 6, 44 to 46.

Maintained by Gerard Blokdyk

Other controls in Chapter 6: Production and service controls – MDSAP Audit Approach (MDSAP AU P0002)

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll MDSAP Audit Approach (MDSAP AU P0002) controls