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JIS MEDICAL DEVICES II - JIS Medical Devices II Handbook
January 1, 2015 - JSA
A description is not available for this item.
JIS MEDICAL DEVICES IV - JIS Medical Devices IV Handbook
January 1, 2015 - JSA
A description is not available for this item.
JIS MEDICAL DEVICES I - JIS Medical Devices I Handbook
January 1, 2015 - JSA
A description is not available for this item.
JIS MEDICAL DEVICES III - JIS Medical Devices III Handbook
January 1, 2015 - JSA
A description is not available for this item.
ISO DIS 14971 - Medical devices - Application of risk management to medical devices
July 19, 2018 - ISO

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic (IVD) medical devices. The process described in this document intends to assist...

CSA Z314 - Canadian medical device reprocessing
January 1, 2018 - CSA

This Standard is intended to address the safe, effective, and reliable reprocessing of reusable medical devices at each phase of the reprocessing workflow, including a) establishing a QMS for the MDRD, including i) key performance indicators; ii) policies and procedures; iii)...

DS/ISO/IEEE 11073-20702 - Health informatics – Point-of-care medical device communication – Part 20702: Medical devices communication profile for web services
September 3, 2018 - DS

Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care (PoC) medical device communication, a communication protocol specification for a distributed system of PoC medical devices and medical IT systems that need to exchange data,...

ISO/IEEE 11073-20702 - Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
September 1, 2018 - ISO

The scope of this standard is a communication protocol specification for a distributed system of point-of-care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked PoC medical devices by defining a profile for Web...

ISO DIS 10993-18 - Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Évaluation biologique
August 8, 2018 - ISO

This document specifies a framework for the identification of biological hazards and the estimation and control of biological risks from material constituents, using a stepwise approach to the characterization of a medical device through: - the identification of its materials of...

Handbook of Medical Device Regulatory Affairs in Asia
April 4, 2018 - CRC

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy,...

ISO 7405 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
October 1, 2018 - ISO

This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and...

IEEE 11073-20702 - Health informatics - Point-of-care medical device communication - Part 20702: Medical Devices Communication Profile for Web Services
January 1, 2018 - IEEE

The scope of this standard is a communication protocol specification for a distributed system of point-of-care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked PoC medical devices by defining a profile for Web...

ISO TR 80002-2 - Medical device software - Part 2: Validation of software for medical device quality systems
June 1, 2017 - ISO

This document applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485. This document...

CSA ISO 17664 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
January 1, 2018 - CSA

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective...

21 CFR PART 803 - MEDICAL DEVICE REPORTING
April 1, 2016 - DOL

What does this part cover? (a) This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device...

21 CFR PART 821 - MEDICAL DEVICE TRACKING REQUIREMENTS
April 1, 2017 - FAA

(a) The regulations in this part implement section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act), which provides that the Food and Drug Administration may require a manufacturer to adopt a method of tracking a class II or class III device, if the device meets one of the...

DS/EN ISO 15225 - Medical devices – Quality management – Medical device nomenclature data structure
April 14, 2016 - DS

ISO 15225:2016 specifies rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers,...

ISO 15225 - Medical devices - Quality management - Medical device nomenclature data structure
March 15, 2016 - ISO

This International Standard specifies rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities,...

Flexible and Stretchable Medical Devices
June 1, 2018 - WILEY
A description is not available for this item.
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