Abbreviation Index:

RIMD: Reusable Invasive Medical Device.

FDA: Food Drug Administration.

EU: European Union.

URS: User Requirement Specification.

FS: Functional Specification.

DQ: Design Qualification.

IQ: Installation Qualification.

OQ: Operational Qualification.

PQ: Performance Qualification.

CFR: Code of Federal Regulation.

QSR: Quality System Regulation.

ISO 13485: International Standard for Medical Device Manufacturing.

CDRH: Centre for Devices and Radiological Health.

cGMP: Current Good Manufacturing Practices.

HVAC: High Ventilation and Air Conditioning system.

HEPA: High Efficiency Particulate Air Filter.

FAT: Factory Acceptance Test.

SAT: Site Acceptance Test.

PM: Preventive Maintenance.

EMO: Emergency Machine Off.

EPO: Emergency Power Off.

P&ID: Piping and Instrument Diagram.

STM: Standard Test Method.

PPQ: Process Performance Qualification.

ISO 14971: International Standard for Risk Management.

VMP: Validation Master Plan.

VSR: Validation Summary Report.

SOP: Standard Operation Procedure.

R&D: Research and Development.

P&D: Process and Development.

OOS: Out of Specification.

QA: Quality Assurance.

QC: Quality Control.

RA: Regulator Affairs.

GMP: Good Manufacturing Practises.

Cp: Process Capability Ratio.

Cpk: Process Capability Index.