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3.17reusable containerrigid sterile barrier system designed to be repeatedly used3.18sealresult of joining surfaces togetherNote 1 to entry: For example, surfaces can be jointed together by use of adhesives or thermal fusion.3.19seal integritycharacteristic of the seal which ensures that it prevents the ingress of microorganisms, demonstratedunder test conditions which consider sterilization process, handling, distribution, transport and storage3.20seal strengthmechanical strength of the seal3.21sterilefree from viable microorganisms[SOURCE: ISO/TS 11139:2006]3.22sterile barrier systemminimum package that prevents ingress of microorganisms and allows aseptic presentation of theproduct at the point of use[SOURCE: ISO/TS 11139:2006]4

3.23sterile fluid-path packagingsystem of protective port covers and/or packaging designed to ensure sterility of the portion of themedical device intended for contact with fluidsNote 1 to entry: An example of sterile fluid-path packaging would be the interior of the tubing for administrationof an intravenous fluid.3.24sterilization compatibilityattributes of the packaging material and/or system that allow it to both withstand the sterilizationprocess and attain the required conditions for sterilization within the packaging system3.25sterilizing agentphysical or chemical entity, or combination of entities having sufficient microbicidal activity to achievesterility under defined conditions[SOURCE: ISO/TS 11139:2006]3.26terminal sterilizationprocess whereby product is sterilized within its sterile barrier system3.27useful lifethe time period during which all the performance requirements are met3.28validation〈general〉 confirmation by examination and provision of objective evidence that the particularrequirement for a specific intended use can be consistently fulfilledNote 1 to entry: This definition is applicable to validation of test methods and design.3.29validation〈process〉 documented procedure for obtaining, recording and interpreting the results required toestablish that a process will consistently yield product complying with predetermined specificationsNote 1 to entry: Adapted from ISO/TS 11139:2006.4 General requirements4.1 GeneralCompliance with one or more requirements of this part of ISO 11607 may be demonstrated by using oneor more parts of the series EN 868-2 to EN 868-10.4.2 Quality systems4.2.1 The activities described within this part of ISO 11607 shall be carried out within a formalquality system.NOTE ISO 9001 and ISO 13485 contain requirements for suitable quality systems. Additional requirementsmay be specified by a country or region.4.2.2 It shall not be necessary to obtain third-party certification of the quality system to fulfil therequirements of this part of ISO 11607.