Sterilization verification evidence and source custody

BIO.01.02officeUnion-wide competence

Purpose and competence

Sterilization verification evidence and source custody is maintained for Sterilization verification. Its scope follows the office’s mandate: Verify a declared sterilisation process through traceable tests and configuration custody.

A cleaned assembly is reopened during repairs without a supported recleaning record

Record specification

Record identifier: BIO.01.02/R2
Responsible custodian: Sterilization verification
Source evidence: process validation; equipment configuration; residual burden
Decision output: Sterilisation verification finding
Publication status: Draft record specification / no signed decision
Review route: Union Ombudsman / Union Court of Justice

Custodian and access

Sterilization verification assessment lead → · Public records access procedure

Source catalogue for Sterilization verification

Source 1: process validation
Source 2: equipment configuration
Source 3: residual burden
Receiving purpose: Sterilisation verification finding

Access to this record

Sterilization verification assessment lead / contact · Public records procedure · Common custody and accessible-format rules