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This Standard addresses issues related to the safety of human allogeneic and autologous cells of lymphohematopoietic origin used for transplantation and includes quality system requirements. This Standard includes aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to or affected by the transplant of lymphohematopoietic cells. The…
Specification for radio disturbance and immunity measuring apparatus and methods - Part 4-4: Uncerta...
CISPR TR 16-4-4:2007+AMD1:2017 contains a recommendation on how to deal with statistics of radio interference complaints. Furthermore it describes the calculation of limits for disturbance field strength and voltage for the measurement on a test site based on models for the distribution of disturbances by radiated and conducted coupling. This second edition of CISPR 16-4-4 contains two thoroughly…
Medical device software - Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017(E) 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.
ISO/TR 80002-2:2017 applies to
- software used in the quality management system,
- software used in production and service…
Medical device software — Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 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.
ISO/TR 80002-2:2017 applies to
- software used in the quality management system,
- software used in production and service…
Application integration at electric utilities - System interfaces for distribution management - Part...
IEC 61968-3:2017 defines a Network Operations function which provides utilities the means to supervise main substation topology (breaker and switch state) and control equipment status. It also provides the means for handling network connectivity and loading conditions. Finally, it makes it possible for utilities to locate customer telephone complaints and supervise the location of field crews.…
This International Standard provides guidance to all types of organizations, regardless of their size or location,
on:
a) concepts, terms and definitions related to social responsibility;
b) the background, trends and characteristics of social responsibility;
c) principles and practices relating to social responsibility;
d) the core subjects and issues of social responsibility;
e) integrating,…
Specification for radio disturbance and immunity measuring apparatus and methods - Part 3: CISPR tec...
CISPR TR 16-3:2010+A1:2012+A2:2015(E) is a collection of technical reports that serve as background and supporting information for the various other standards and technical reports in CISPR 16 series. In addition, background information is provided on the history of CISPR, as well as a historical reference on the measurement of interference power from household and similar appliances in the VHF…
Quality management — Customer satisfaction — Guidelines for complaints handling in organizations
ISO 10002:2014 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance, and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system.
ISO 10002:2014 is not applicable to disputes referred for resolution outside the…
Specification for radio disturbance and immunity measuring apparatusand methods - Part 3: CISPR tech...
CISPR/TR 16-3:2010+A1:2012(E) is a collection of technical reports that serve as background and supporting information for the various other standards and technical reports in CISPR 16 series. In addition, background information is provided on the history of CISPR, as well as a historical reference on the measurement of interference power from household and similar appliances in the VHF range.…
