Medical Devices

EN 980 / EN 1041 / EN ISO 14971 / EN ISO 13485 Medical Devices Package

EN 980, EN 1041, EN ISO 14971, and EN ISO 13485 - Historical Package (European Standard)

EN 980, EN 1041, EN ISO 14971, and EN ISO 13485 Medical Devices Package specifies the requirements for medical devices information supplied by a manufacturer along with symbols and labeling used in conjunction with that information. This package also provides the application of risk management and quality management systems in association with medical devices.

The EN 980, EN 1041, EN ISO 14971 and EN ISO 13485 Medical Devices Package includes:

• EN 980:2008 - Historical Document
• EN ISO 13485:2016
• EN ISO 14971:2019
• EN 1041:2008+A1:2013

ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package

ISO 13485 And ISO/TR 14969 Quality Management Systems Medical Devices Package

The ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package specifies the requirements and procedures to implement a quality management system for an organization that needs to consistently meet regulatory requirements applicable to medical devices and related services. The guidance standard ISO/TR 14969 provides approaches to establish objectives, implement, monitor and measure the processes to improve performance. The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs or services medical devices or provides related services. This package has a total savings of 30% off the list price and includes:

• ISO 13485:2016
• ISO 13485:2016 - Medical devices - A practical guide
• ISO/TR 14969:2004 Historical Document

ISO 13485 and ISO 14971 - Medical Devices Package

ISO 13485 / ISO 14971 - Medical Devices Package (Save 15% Off List Prices)

The ISO 13485 and ISO 14971 - Medical Devices Package provides regulatory requirements for quality management medical device systems and incorporating and maintaining a risk management system associated with the use of medical devices. This package includes:

• ISO 13485:2016
• ISO 13485:2016 - Medical devices - A practical guide
• ISO 14971:2007
• ISO14971:2019

ISO 13485 / 14971 / 14969 - Medical Devices Package

ISO 13485 / 14971 / 14969 - Medical Devices Package (Save 12% Off List Prices)

The ISO 13485 / 14971 / 14969 - Medical Devices Package provides regulatory requirements for quality management medical device systems and incorporating and maintaining a risk management system associated with the use of medical devices. This package includes:

• ISO 13485:2016
• ISO 13485:2016 - Medical devices - A practical guide
• ISO 14971:2019
• ISO/TR 14969:2004 Historical Document

ISO 11737 - Sterilization of Medical Devices Package

ISO 11737 - Sterilization Of Medical Devices Package (Save 29% Off List Prices)

The ISO 11737 - Sterilization of Medical Devices Package provides the requirements to estimate and determine the population of viable microorganisms on a product and to test the sterility of a product that has been treated with a sterilizing agent. The determination of bioburden can be used to validate the sterilization process, monitor the manufacturing processes and assess the overall environmental monitoring programme. It has been reduced 25% off the list price. This package includes:

• ISO 11737-1:2018
• ISO 11737-2:2019

ISO 11137 - Sterilization of Health Care Products Package

ISO 11137-1, ISO 11137-2 And ISO 11137-3

The ISO 11137 - Sterilization of Health Care Products Package provides the requirements for developing, validating and routinely controlling the sterilization process of medical devices. In addition to providing the requirements for the sterilization process of medical devices, this package also considers the products' environment, personnel and their hygiene, packaging / storage, sterilization doses and more to inactivate microbiological contaminants on medical devices.

This package includes the following ISO Standards:

• ISO 11137-1:2006
• ISO 11137-1:2006/Amd1:2013
• ISO 11137-2:2013
• ISO 11137-3:2017

ISO 10993 - Biological Evaluation of Medical Devices Package

ISO 10993 - Medical Devices Complete Set, Parts 1 Thru 20 (Save 55% Of List Prices)

The ISO 10993 - Biological Evaluation of Medical Devices Package has an array of standards on testing, the identification / quantification of degradation products and other general biological evaluation of medical devices. The general biological evaluation of medical devices standards in this package include basic evaluation and testing, sterilization residuals, limits for leachable substances, and the preparation of samples / reference materials for testing. The referenced products are for the identification / quantification of degradation products are metals / alloys, ceramics and polymeric devices. These particular standards are supported by a toxicokinetic study design standard and framework standard for potential degradation products. The medical devices tests in this package are for system toxicity, hypersensitivity, local effects after implantation, genotoxicity, carcinogenicity, reproductive toxicity and interactions with blood.

This package is 55% off the individual list price and includes the following standards:

• ISO 10993-1:2018
• ISO 10993-2:2006
• ISO 10993-3:2014
• ISO 10993-4:2017
• ISO 10993-5:2009
• ISO 10993-6:2016
• ISO 10993-7:2008
• ISO 10993-7/Cor1:2009
• ISO 10993-9:2019
• ISO 10993-10:2010
• ISO 10993-11:2017
• ISO 10993-12:2012
• ISO 10993-13:2010
• ISO 10993-14:2001
• ISO 10993-15:2019
• ISO 10993-16:2017
• ISO 10993-17:2002
• ISO 10993-18:2020
• ISO/TS 10993-19:2020
• ISO/TS 10993-20:2006

IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package

IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package

IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package provides assistance with the proper use of medical devices as it pertains to human risk factors. It specifies safety-related processes to analyze, develop, and evaluate the usability of medical devices. The IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package is applicable to "normal" medical devices usage and is supported with guidance information. IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package includes:

• IEC 62366-1 Ed. 1.0 b:2015
• IEC 62366-1 Ed. 1.0 b cor:1:2016
• IEC 62366-1 Amd.1 Ed. 1.0 b:2020
• IEC/TR 62366-2 Ed. 1.0 en:2016

IEC 60601-1 / 60601-1-2 / 60601-1-4 / 60601-1-6 Medical Electrical Equipment Package

IEC 60601-1 / 60601-1-2 / 60601-1-4 / 60601-1-6 Medical Electrical Equipment Package

IEC 60601-1 / 60601-1-2 / 60601-1-4 / 60601-1-6 Medical Electrical Equipment Package provide the general requirements for basic safety and essential performance of medical electrical equipment and medical electrical systems. The general requirements of medical electrical equipment includes testing, classification, identification / marking and protection against electrical hazards. The IEC 60601-1 / 60601-1-2 / 60601-1-4 / 60601-1-6 Medical Electrical Equipment Package specifically address electromagnetic compatibility, programmable electrical medical systems and usability of medical electrical equipment. This package includes:

• IEC 60601-1 Ed. 3.1 en:2012
• IEC 60601-1 Amd.2 Ed. 3.0 en:2020
• IEC 60601-1-2 Ed. 4.0 b:2014
• IEC 60601-1-4 Ed. 1.1 b:2000 - HISTORICAL DOCUMENT
• IEC 60601-1-6 Ed. 3.1 b:2013

ISO 15223 - Symbols for Medical Devices Package

ISO 15223-1 And ISO 15223-2

The ISO 15223 - Symbols for Medical Devices Package provides the requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices. It also specifies a process for developing, selecting and validating symbols which may be used on the device, its package or in associated documentation. The ISO 15223 - Symbols for Medical Devices Package includes ISO 15223-1:2016 and ISO 15223-2:2010.

ISO 15223 - Symbols for Medical Devices Package includes:

• ISO 15223-1:2016
• ISO 15223-2:2010

ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package

ISO 13485 / IEC 62304 / ISO 14971 - Software, Quality And Risk Management Of Medical Devices

The ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package provides the support to develop, implement, and maintain a medical devices quality and risk management system. It also includes the requirements for the software life cycle process for medical device software.

The ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package consolidates the IT, quality, and risk management medical devices necessities. It includes:

• IEC 62304 Ed. 1.0 b:2006
• IEC 62304 Amd.1 Ed. 1.0 b:2015
• ISO 13485:2016
• ISO 13485:2016 - Medical devices - A practical guide
• ISO 14971:2019

ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package

ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices

ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package establishes the risk management process associated with the biological evaluation of medical devices. It also provides test methods for in vitro cytotoxicity, irritation and skin sensitization involving medical devices.

ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package includes:

• ISO 10993-1:2018
• ISO 10993-5:2009
• ISO 10993-10:2010

ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set

ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set provides the regulatory reguirements for your medical devices quality management system. ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set enables an organization to consistently meet customer and regulatory expectations as it pertains to the quality management of medical devices. The ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set is applicable to all medical devices organizations and it includes:

• SIST EN ISO 9001:2015
• SIST EN ISO 13485:2016

ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set

ISO 13485:2016 And ISO 13485:2003 - Medical Devices Transition Set

ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set provides the latest medical devices quality management system requirements for regulatory purposes. The Medical Devices Transition Set has been designed to be applicable medical device QMS at various stages of the life cycle including design/development, production, storage, distribution, installation, and servicing. ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set also enables for organizations to demonstrate their ability to comply with regulatory requirements regardless of their size and type. ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set supports an organization in need of transitioning their Medical Devices QMS program from ISO 13485:2003 to ISO 13485:2016 by providing both versions of the medical devices quality management systems documents for comparison.

The ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set includes:

• ISO 13485:2016
• ISO 13485:2003 (Historical Document)

IEC 60601-1 and IEC 60601-1-2 Medical Electrical Equipment Package

IEC 60601-1 And IEC 60601-1-2 Medical Electrical Equipment Package

IEC 60601-1 and IEC 60601-1-2 Medical Electrical Equipment Package provide the general requirements for basic safety and essential performance of medical electrical equipment and medical electrical systems. The general requirements of medical electrical equipment includes testing, classification, identification / marking and protection against electrical hazards. The IEC 60601-1 and IEC 60601-1-2 Medical Electrical Equipment Package specifically address the electromagnetic compatibility of medcial electrical equipment. This package includes:

• IEC 60601-1 Ed. 3.1 en:2012
• IEC 60601-1 Amd.2 Ed. 3.0 en:2020
• IEC 60601-1-2 Ed. 4.0 b:2014

EN ISO 18113 - In Vitro Diagnostic Medical Devices Package

EN ISO 18113-1, EN ISO 18113-2 And EN ISO 18113-3 (European Standard)

EN ISO 18113 - In Vitro Diagnostic Medical Devices Package defines concepts, establishes general principles and specifies essential requirements for information supplied by manufacturers of IVD medical devices. EN ISO 18113 - In Vitro Diagnostic Medical Devices Package includes:

• EN ISO 18113-1:2011
• EN ISO 18113-2:2011
• EN ISO 18113-3:2011

EN ISO 14971 / IEC 60601-1-2 - Risk Management of Medical Electrical Equipment Package

EN ISO 14971 And IEC 60601-1-2 (European Standard)

The BS EN ISO 14971 / IEC 60601-1-2 - Risk Management of Medical Electrical Equipment Package specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems, while identifying the hazards and risks associated with them. It also provides the means to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls of the risk associated with medical electrical devices. BS EN ISO 14971 / IEC 60601-1-2 - Risk Management of Medical Electrical Equipment Package includes:

• EN ISO 14971:2019
• EN 60601-2-1:2015 (IEC 60601-1-2 Ed. 4.0 b:2014)

EN ISO 14971 / EN ISO 11607 - Medical Devices Package

Risk And Package Of Medical Devices: EN ISO 14971, EN ISO 11607-1 And EN ISO 11607-2 (European Standard)

EN ISO 14971 / EN ISO 11607 - Medical Devices Package provides the requirements and test methods for packaging intended to maintain the sterility of terminally sterilized medical devices until the point of use. It also provides the requirements for the development and validation of processes including forming, sealing, and assembly of packaging used for sterilized medical devices. The EN ISO 14971 / EN ISO 11607 - Medical Devices Package also allows for a process that enables manufacturers to identify hazards associated with medical devices. It includes:

• EN ISO 14971:2019
• EN ISO 11607-1:2020
• EN ISO 11607-2:2020

EN ISO 14971 / EN 980 - Symbols and Risk Management of Medical Devices Package

EN ISO 14971 And EN 980 - Historical Package (European Standard)

The EN ISO 14971 / EN 980 - Symbols and Risk Management of Medical Devices Package provides the specifications to identify the risk associated with the use of medical devices, while also specifying the labeling of symbols supplied by the manufacturer of medical devices. This package is the perfect manufacturers' guide to identify the risk of medical devices to the consumer and relay those risk using uniform symbols. EN ISO 14971 / EN 980 - Symbols and Risk Management of Medical Devices Package includes:

• EN ISO 14971:2019
• EN 980:2008 - Historical Document

ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices Package

ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices Package

ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices Package provides the requirements necessary to protect terminally sterilized medical devices until the point of use.

ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices also provides the requirements to be used for the development, selection, and validation of medical devices symbols. In addition, the package suggests the risk management process for terminally sterilized medical devices and the package includes:

• ISO 15223-1:2016
• ISO 15223-2:2010
• ISO 11607-1:2019
• ISO 11607-2:2019
• ISO 10993-1:2018

ISO 13485 / ISO 9001 - Medical Devices Quality Management Set

ISO 13485 And ISO 9001

The ISO 13485 / ISO 9001 - Medical Devices Quality Management Set specifies regulatory requirements for a medical device quality management system that can be used by organizations, suppliers and others involved in the various stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing, final decommissioning, and disposal of medical devices. ISO 13485 / ISO 9001 - Medical Devices Quality Management Set includes:

• ISO 13485:2016
• ISO 9001:2015
• ISO 13485:2016 - Medical devices - A practical guide

ISO 11138 - Sterilization of Health care Products Package

ISO 11138 - Sterilization Of Health Care Products Package - Parts 1 To 7

ISO 11138 - Sterilization of Health care Products Package provides methods for testing systems containing viable microorganisms providing a defined resistance to a specified sterilization process. The biological indicators sterilization processes supported in the ISO 11138 - Sterilization of Health care Products Package includes ethylene oxide, moist heat, dry heat, low-temperature steam, and formaldehyde.

This package includes the following standards:

• ISO 11138-1:2017
• ISO 11138-2:2017
• ISO 11138-3:2017
• ISO 11138-4:2017
• ISO 11138-5:2017
• ISO 11138-7:2019

ISO 21549 - Health Informatics Package

ISO 21549-1, ISO 21549-2, ISO 21549-3, ISO 21549-4, ISO 21549-5, ISO 21549-6, ISO 21549-7 And ISO 21549-8

The ISO 21549 - Health Informatics Package provides the platform for developing the structure of the patient health card data. The structure consists of device data, identification data, administrative data, clinical data, electronic prescription, security data and limited / extended clinical data. Additional standards are included that establish a common framework for the content / structure, architecture for electronic health records, physical characteristics of the health card and good principles and practices for a clinical data warehouse. This package contains the following documents:

• ISO 21549-1:2013
• ISO 21549-2:2014
• ISO 21549-3:2014
• ISO 21549-4:2014
• ISO 21549-5:2015
• ISO 21549-6:2008
• ISO 21549-7:2016
• ISO 21549-8:2010

EN ISO 13485 / EN ISO 14971 - Risk and Quality Management Medical Devices Package

EN ISO 13485 And EN ISO 14971 (European Standard)

The EN ISO 13485 / EN ISO 14971 - Risk and Quality Management Medical Devices Package provides regulatory requirements for quality management medical device systems and incorporating and maintaining a risk management system associated with the use of medical devices.

The BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package includes:

• EN ISO 13485:2016
• EN ISO 14971:2019

ISO 11607 - Terminally Sterilized Medical Devices Package

ISO 11607 - Terminally Sterilized Medical Devices Package.

The ISO 11607 - Terminally Sterilized Medical Devices Package provides the requirements and test methods for packaging intended to maintain the sterility of terminally sterilized medical devices until the point of use. It also provides the requirements for the development and validation of processes including forming, sealing, and assembly of packaging used for sterilized medical devices. This package includes ISO 11607-1:2019, ISO 11607-2:2019. It has been reduced 15% off of the individual list price.

ISO 11607 - Terminally Sterilized Medical Devices Package includes:

• ISO 11607-1:2019
• ISO 11607-2:2019

EN 62366 / EN ISO 14971 / EN 1041 / ISO 10993-1 - Medical Devices Package

EN 62366, EN ISO 14971, EN 1041 And ISO 10993-1 (EU Standard)

EN 62366 / EN ISO 14971 / EN 1041 / ISO 10993-1 - Medical Devices Package specifies the process for a manufacturer to analyze, specify, design, verify and validate usability, as it relates to safety of a medical device. It also provides risk management application, evaluation and testing associated with medical devices.

EN 62366 / EN ISO 14971 / EN 1041 / ISO 10993-1 - Medical Devices Package includes:

• EN 1041:2008+A1:2013
• EN 10993-1:2018
• EN 62366-1:2015+A1:2020
• EN ISO 14971:2019

ISO 18562 Evaluation of Breathing Gas Pathways Package

ISO 18562 - Evaluation Of Breathing Gas Pathways Package

Access guidelines and general principles to evaluate and test the biocompatibility of breathing gas pathways in healthcare applications. The ISO 18562 package is applicable to breathing gas medical devices such as ventilators, anesthesia workstations, breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices.

ISO 18562 - Evaluation of Breathing Gas Pathways Package includes:

• ISO 18562-1:2017
• ISO 18562-2:2017
• ISO 18562-3:2017
• ISO 18562-4:2017