Biomaterial Database

An international standard for terminally sterilized medical device packaging. 1997

M E Donawa

Donawa and Associates Ltd, Rome, Italy. donawa@srd.it

Manufacturers of terminally sterilized medical devices must ensure that packaging protects the device from damage, allows it to be sterilized, and provides an effective barrier against microbiological contamination. The previous article in this column discussed quality system requirements for packaging. Recently, an international standard concerning sterile packaging has been developed and this article provides an overview of the standard.

UI	MeSH Term	Description	Entries
D008422	Materials Testing	The testing of materials and devices, especially those used for PROSTHESES AND IMPLANTS; SUTURES; TISSUE ADHESIVES; etc., for hardness, strength, durability, safety, efficacy, and biocompatibility.	Biocompatibility Testing,Biocompatible Materials Testing,Hemocompatibility Testing,Testing, Biocompatible Materials,Testing, Hemocompatible Materials,Hemocompatibility Testings,Hemocompatible Materials Testing,Materials Testing, Biocompatible,Materials Testing, Hemocompatible,Testing, Biocompatibility,Testing, Hemocompatibility,Testing, Materials,Testings, Biocompatibility
D011785	Quality Assurance, Health Care	Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.	Quality Assessment, Health Care,Health Care Quality Assessment,Health Care Quality Assurance,Healthcare Quality Assessment,Healthcare Quality Assurance,Quality Assessment, Healthcare,Quality Assurance, Healthcare,Assessment, Healthcare Quality,Assessments, Healthcare Quality,Assurance, Healthcare Quality,Assurances, Healthcare Quality,Healthcare Quality Assessments,Healthcare Quality Assurances,Quality Assessments, Healthcare,Quality Assurances, Healthcare
D004864	Equipment and Supplies	Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures.	Apparatus and Instruments,Devices,Medical Devices,Device, Medical,Devices, Medical,Equipment,Inventories,Medical Device,Supplies,Device,Instruments and Apparatus,Inventory,Supplies and Equipment
D005060	Europe	The continent north of AFRICA, west of ASIA and east of the ATLANTIC OCEAN.	Northern Europe,Southern Europe,Western Europe
D013242	Sterilization	The destroying of all forms of life, especially microorganisms, by heat, chemical, or other means.
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D015203	Reproducibility of Results	The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.	Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D019064	Product Packaging	Form in which product is processed or wrapped and labeled. PRODUCT LABELING is also available.	Packaging, Product,Product Containers,Packaging,Container, Product,Containers, Product,Packagings,Packagings, Product,Product Container,Product Packagings