The Device History Record obligation of §820.184 required batch-level production records demonstrating conformance with the DMR. Sterilization batch parameter records and their linkage to production lots were required to populate a complete DHR. That foundational recordkeeping obligation continues under §7.5.5.
§7.5.5 creates an explicit, named requirement for sterile-device manufacturers: sterilization process parameters must be recorded per batch, and those records must be traceable to each production batch. This makes the traceability obligation specifically auditable as a device-category requirement — separate from the general DHR content rules — and applies it directly to sterile medical devices without requiring derivation from the broader DHR framework.
Auditors will test bidirectional traceability: given a production lot, identify the sterilization cycle; given a sterilization batch record, identify all production lots processed. Full process parameter values per cycle — not only outcome certificates — must be on file. Contract sterilization quality agreements will be reviewed to confirm parameter record and traceability requirements are flowed down.
Maps to
QMSR / ISO 13485: §820.184 Device history record.
ISO 13485: §7.5.5 Particular requirements for sterile medical devices
Requirement text
The organization shall maintain records of the sterilization process parameters used for each sterilization batch (see 4.2.5). Sterilization records shall be traceable to each production batch of medical devices.
Why this clause exists
Sterility is a binary attribute — a device is either sterile or it is not — and sterilization processes are validated rather than verified by end-product testing, because testing to verify sterility would be destructive and statistically insufficient. For sterile medical devices, the integrity of the sterilization process run is the primary assurance mechanism for the sterility of the finished product. If sterilization process parameters deviate from validated ranges during a batch run, the sterility assurance level for that batch may be compromised even if the devices appear normal on inspection.
ISO 13485 §7.5.5 addresses this by requiring records of sterilization process parameters for each sterilization batch, with traceability linking those records to the production batch of medical devices processed. This two-level traceability — process parameters to batch, batch to devices — creates the accountability chain necessary to support post-market surveillance decisions, recall scope determination, and investigation of sterility-related complaints.
The traceability obligation connects directly to the device history record (DHR) requirements and to the recall and field action infrastructure: if a sterilization parameter deviation is discovered retrospectively, the organization must be able to identify which specific devices were processed in the affected batch. Without batch-level parameter records linked to production batches, this determination cannot be made and the affected population cannot be bounded. §7.5.5's compact text carries substantial risk-management weight through this traceability mechanism.
The validation of sterilization processes themselves is addressed separately by §7.5.7 — §7.5.5 addresses the production-run records, not the validation of the process design.
What changed
§820.184 — Part 820 (legacy)
"Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information: (a) The dates of manufacture; (b) The quantity manufactured; (c) The quantity released for distribution; (d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR; (e) The primary identification label and labeling used for each production unit; and (f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used."
§7.5.5 — ISO 13485:2016 (current)
"The organization shall maintain records of the sterilization process parameters used for each sterilization batch (see 4.2.5). Sterilization records shall be traceable to each production batch of medical devices."
Common gaps (what we see in audits)
- Sterilization Records Not Traceable to Production Batches — Sterilization cycle records are maintained by the sterilization function separately from production batch records in the DHR. The linkage between which sterilization cycle processed which production lot is not documented in either record set. ISO 13485 §7.5.5 requires that sterilization records be traceable to each production batch of medical devices.
- Contract Sterilizer Records Not Integrated Into Organization's Batch Records — The organization uses a contract sterilizer. The contract sterilizer maintains its own cycle records, but those records are not incorporated into the organization's DHR as required sterilization batch records with production-batch traceability. The organization retains a sterilization certificate but not the full parameter record.
- Not All Required Process Parameters Documented per Cycle — Sterilization records exist but capture only the final cycle outcome (pass/fail or dose certificate) without the individual process parameter values recorded during the cycle (e.g., temperature profile, exposure time, EO concentration readings). ISO 13485 §7.5.5 requires records of the process parameters used, not merely the outcome.