ISO 5910:2018 pdf free download.Cardiovascular implants and extracorporeal systems – Cardiac valve repair devices.
No heart valve repair device is ideal. Therefore, a group of engineers, scientists, and clinicians, experts well aware of the problems associated with heart valve repair devices and their development, has prepared this document. ISO 5910 specifies types of tests, test methods, and requirements for test apparatus. It requires documentation of test methods and results. ISO 5910 deals with those areas that will ensure adequate mitigation of device-associated risks for patients and other users of the device, facilitate quality assurance, aid the heart team in choosing a heart valve repair device, and ensure that the device will be provided in a convenient and usable form. ISO 5910 emphasizes the need to specify and report types of in vitro testing. preclinical in vivo and clinical evaluations. It describes the labels and packaging of the device. Such a process involving in vitro, preclinical in vivo and clinical evaluations is intended to clarify the requirements prior to market release and to enable prompt identification and management of any subsequent problems.
With regard to in vitro testing and reporting, apart from basic material testing for mechanical, physical. chemical and biocompatibility characteristics, ISO 5910 also covers important functional and durability characteristics of heart valve repair devices and their accessories. ISO 5910 does not specify exact test methods for functional and durability testing but it offers guidelines for the test apparatus.
ISO 5910 should be revised, updated, and amended as knowledge and techniques in heart valve repair device technology improve.
1.1 ISO 5910 applies to all heart valve repair systems that have an intended use to repair and/ or improve the function of native human heart valves by acting either on the valve apparatus or on the adjacent anatomy (e.g. ventricle, coronary Sinus).
1.2 ISO 5910 outlines an approach for verifying/validating the design and manufacture of a heart valve repair system through risk management. The selection of appropriate verification/validation tests and methods are derived from the risk assessment. The tests include assessments of the physical. chemical, biological, and mechanical properties of components and materials of heart valve repair systems. The tests also include preclinical in vivo evaluation and clinical investigation of the finished heart valve repair system to assess the safety and effectiveness of the heart valve repair system.
NOTE For the purposes of ISO 5910, effectiveness endpoint includes clinical performance and benefits.
1.3 ISO 5910 defines operational conditions and performance requirements for heart valve repair systems where adequate scientific and/or clinical evidence exists for their justification.
1.4 ISO 5910 excludes Cardiac Resynchronization Therapy (CRT) devices, paravalvular leakage closure devices, systems that do not leave an implant in place (e.g. ablation, radio frequency annuloplasty), apical conduits and devices with components containing viable cells. ISO 5910 also excludes materials not intended for repairing and/or improving the function of human heart valves according to its intended use (e.g. patch material and sutures used in general surgical practice).
NOTE A rationale for the provisions of this document is given in Annex A.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of ISO 5910. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements jl,r
forming, sealing and assembly processes
ISO 13485. Medical devices — Quality management ,ystems — RequIrements for regulatory purposes
ISO 14155, Clinical investigation of medical devices jar human subjects — Good clinical practice
ISO 14160, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements far characterization, development; validation and routine control of a sterilization process for medical devices
ISO 14630, Non-active surgical Implants — General requirements
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols w be used with medical device labels, labelling and Information to be supplied — Part 1: General requirements
ISO 15223-2. Medical devices — Symbols to be used with medical device labels labelling, and information to be supplied — Part 2: Symbol development, selection and validation
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories ISO 17664, ProcessIng of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 17665-1,Sterilization of health care products— Moist heat— Part 1: Requirem entsforthe development. validation and routine control of a sterilization process for medical devices
ISO/TS 17665-2, Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
ISO/TS 17665-3, Sterilization of health care products — Moist heat — Part 3: GuIdance on the designation ala medical device to a product family and processIng category for steam sterilization
ISO 22442-I, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
ISO 224 42-2. Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing. collection and handling
ISO 22442-3, Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ISO/TR 22442-4, MedIcal devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopatl,y (TSE) agents and validation assays for those processes
IEC 62366.1, Medical devices — Part 1: Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain termlnological databases for use In standardization at the Following addresses
6.2.5 Packaging, labelling, and sterilization
The heart valve repair system shall meet the requirements for packaging, labelling, and sterilization contained within Annex C. Annex 1). and Annex E, respectively.
6.3 Design outputs
The manufacturer shall establish (I.e. define, document, and implement) a complete speclllcatlon of the heart valve repair system, including component and assembly-level specifications, delivery system, accessories, packaging, and labelling. Annx..il contains examples of various heart valve repair devices and Annex F contains descriptive characteristics for heart valve repair systems. In addition to the physical components olthe heart valve repair system, the Implant procedure itself should be considered an important element of safe and effective heart valvc repair therapy.
6.4 Design transfer (manufacturing veriflcation/vahdation)
The manufacturer shall generate a flowchart identifying the manufacturing process operations and inspection steps. The flowchart shall indicate the input of all components and important manufacturing materials.
As part of the risk management process, the manutacturer shall establish the control measures and process conditions necessary to ensure that the device Is safe and suitable for Its intended use. The risk management file shall Identify and justify the verIfIcation/validatIon activities necessary to demonstrate the acceptability of the process ranges chosen.
The manufacturer shall establish the adequacy ol full scale manufacturing by validation of the manufacturing process. The manufacturer shall vaLidate all special processes and process software and document the results of the validation.
NOTE See ISO 1348S.
7 DesIgn verification testing and analysis / Design validation
7.1 General requirements
The manufacturer shall perform verification testing to demonstrate that the device specifications result in a heart valve repair system that meets the design specifications (design output meets design input). The manufacturer shall establish tests relating to hazards Identified from the risk analysis. The protocols shall Identify the test purpose. set-up, equipment (specifications, calibration, etc.), test conditions (with a justificatIon of appropriateness to anticipated In vivo operating conditions for the device), acceptance criteria, and sample quantities tested. Test methods for verification testing shall be appropriately validated. Refer to applicable sections of ISO/IEC 17025.
The manufacturer shall validate the design of thc heart valve repair system In accordance with 1St) 13485 to ensure that the device specifications conform to user needs and Intended use.
The requirements olthis Standard are equally appllcble to new or modified heart valve repair systems. For heart valve repair systems on the market prior to Implementation of ISO 5910, and for which dinkal evidence of safety and effectiveness exist, demonstration of compliance with all parts of ISO 5910 may not be necessary. The manufacturer shall provide a justification for the lack of any such verification.
7.2 In vitro assessment
7.2.1 General
In vitro assessment shall be used to mitigate risks Identified in the risk analysis. Design specific testing not covered herein may be required based on the findings of the risk analysis.