Implants, prosthetics & orthotics

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Navigating the key standards for implants, prosthetics and orthotics

Medical implants are devices that can be made from synthetic materials which are placed inside the human body for medical purposes, usually for long periods of time. They can be used to replace body parts such as hips or knees, deliver medication such as for pain relief, monitor and regulate body functions such as heart rate, and provide support to organs and tissues. Some implants are composed of inert materials and intended to provide structural support such as surgical meshes or stents. Others are active, in that they interact with the body. High-profile incidents, such as the recall of a type of hip implant in 2010, which had failed in many patients, triggered calls for regulatory change. As a result, the new EU Medical Device Regulation was published in 2017, which aimed to improve the safety and performance of medical devices. It included increased scrutiny of high-risk medical devices such as implants, and stricter criteria for the designation of Notified Bodies to ensure that they have the necessary expertise to evaluate evidence from manufacturers. If you design, develop, manufacture or install any implants, prosthetics, and orthotics, you need to comply with the requirements set out in the relevant regulations/directives. To learn about managing risk in the medical device supply chain, click here. Key Standards for Implants, Prosthetics, and Orthotics BSI can help with best practice guidelines and supporting documentation relating to prosthetics, implants, and orthotics. Our medical device standards specify requirements for: Non-active surgical implants Implants for surgery (including cardiac pacemakers and hip joint prostheses) Prosthetics and orthotics Our implant standards, prosthetics standards, and orthotics standards include: BS EN ISO 13485:2016+A11:2021 Medical devices. Quality management systems. Requirements for regulatory purposes BS EN ISO 13485:2016+A11:2021 is the internationally recognized quality management system (QMS) standard for the medical device industry. The medical device quality management standard specifies requirements for a QMS for those organizations involved in one or more stages of the life cycle of a medical device. The standard provides the framework for design and development, production, storage and distribution, installation, servicing, and final decommissioning and disposal of medical devices and also the design and development or provision of associated activities (e.g. technical support). BS EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer This standard details the information supplied by the manufacturer for a medical device or by the manufacturer for an accessory. This medical device standard covers general requirements for identification and labels on a medical device or accessory, requirements for packaging, requirements for marking of a medical device or accessory, and requirements for accompanying documentation. BS EN ISO 20417:2021 aims to serve as a central source of these common, generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a specific medical device or group of medical devices. The standard contributes to the United Nations (UN) Sustainable Development Goal Number 3 on ensuring healthy lives and promoting well-being for all at all ages. BS ISO 23317:2014 Implants for surgery - In vitro evaluation for apatite-forming ability of implant materials It has been revealed that materials of various kinds bond to living bone through a layer of apatite. It has been shown that this apatite layer can be reproduced on their surfaces in an acellular and protein-free simulated body fluid (SBF) with ion concentrations nearly equal to those of human blood plasma, and that apatite thus formed is similar to the bone mineral in its composition and structure. BS ISO 23317:2014 specifies a method for detecting apatite formed on a surface of a material in SBF. It is applicable to implant surfaces intended to come into direct bone contact. BS EN ISO 25539 Cardiovascular implants - Endovascular devices series This is a multi-part standard divided into the following parts: BS EN ISO 25539-1:2017 Cardiovascular Implants - Endovascular devices. Part 1: Endovascular prostheses BS EN ISO 25539-2:2020 Cardiovascular implants - Endovascular devices. Part 2: Vascular stents BS EN ISO 25539-3:2011 Cardiovascular implants - Endovascular devices. Part 3: Vena cava filters This series specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. BS ISO 13779-1:2008 Implants for surgery - Hydroxyapatite. Part 1: Ceramic hydroxyapatite No known surgical implant material has ever been shown to be completely free of adverse reactions in the human body. However, long-term clinical experience of the use of the material referred to in the BS ISO 13779 series has shown that an acceptable level of biological response can be expected, if the material is used in appropriate applications. BS ISO 13779-1 specifies requirements for ceramic hydroxyapatite intended for use as surgical implants. It applies to hydroxyapatite blocks. It does not apply to hydroxyapatite coatings, hydroxyapatite powder, or nanoparticle-type and calcium phosphate ceramics which are not mainly composed of crystalline hydroxyapatite. BS ISO 13779-2:2018 Implants for surgery - Hydroxyapatite. Part 2: Thermally sprayed coatings of hydroxyapatite BS ISO 13779-2:2018 specifies requirements for single layer thermally sprayed hydroxyapatite coatings applied to metallic surgical implants. These requirements are intended to describe the properties of the materials and to communicate these between organizations. These requirements are not written with the objective of replacing a company’s internal operational and assessment requirements although they could be used as such. This standard does not cover coatings made from glasses, glass ceramics, alpha- and beta-tricalcium phosphate, biphasic calcium phosphate or other forms of calcium phosphate. BS ISO 29782:2008 Prostheses and orthoses - Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation The selection of components to be used in a protheses for a person should take account of their amputation level, stump and general physical characteristics, general clinical condition, functional capabilities, motivation and needs, anticipated activities and social and economic circumstances. The environmental conditions to which the prosthesis will be exposed, and the locally available supply and maintenance arrangements must also be considered. BS ISO 29782:2008 describes the factors to be considered when specifying prostheses for a person who has had a lower limb amputation. BS ISO 7206-1:2008 Implants for surgery - Partial and total hip joint prostheses. Part 1: Classification and designation of dimensions Partial and total hip joint prostheses are designed to transmit load and allow movement under high-stress conditions. Many different designs of hip joint prostheses are used around the world. BS ISO 7206-1:2008 is the first part of a series of test standards that gives a comprehensive description of the most common hip joint prostheses by a detailed classification system. In your quality-critical industry, our tailored BSI Knowledge subscription service puts the control in your hands, with traceability to monitor and demonstrate your business's access to standards. Build your own custom collection of standards, or opt for access to our GBM05 Sciences & Health Care module and keep up-to-date with any relevant changes to your standards strategy. Request to learn more. Ensure your implants, prosthetics and orthotics comply with directives/regulations, and are safe and manufactured to the highest quality by adding these medical device standards to your collection today.

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