Six Sigma Quality International

ISO 16061:2015 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.

This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.

With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.

This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.

This standard is applicable where computer equipment is used to perform functions related to loading and*ship safety, such as, but not limited to, intact and damaged stability and longitudinal strength.*This standard defines requirements to a shipboard loading instrument that is supplementary to IMO MSC/Circ.*836, IMO MSC/Circ. 854, IMO MSC/Circ. 891 and ACS recommendation No. 48

ISO 16239:2013 specifies the material, metric series nominal diameters, diameter tolerances, and designation for screw thread measuring wires.

ISO 16239:2013 is applicable to measure the pitch diameters of ISO general purpose metric screw threads (M), Unified screw threads (UN), Whitworth pipe threads (G, R), and ISO metric trapezoidal screw threads (Tr) with standard pitches. These wires are intended for use on screw threads with a small lead angle, less than 5°, and mainly used to calibrate the pitch diameters of thread plug gauges.

ISO/IEC 17000:2004 specifies general terms and definitions relating to conformity assessment, including the accreditation of conformity assessment bodies, and to the use of conformity assessment to facilitate trade. A description of the functional approach to conformity assessment is included as a further aid to understanding among users of conformity assessment, conformity assessment bodies and their accreditation bodies, in both voluntary and regulatory environments.

ISO/IEC 17000:2004 does not set out to provide a vocabulary for all of the concepts that may need to be used in describing particular conformity assessment activities. Terms and definitions are given only where the concept defined would not be understandable from the general language use of the term or where an existing standard definition is not applicable.

ISO/TR 17068:2012 details the authorized custody services of a Trusted Third Party Repository (TTPR) in order to ensure provable integrity and authenticity of the clients'' digital records and serve as a source of reliable evidence.

It describes the services and processes to be provided by a TTPR for the clients'' digital records during the retention period, to ensure trust. It also details the criteria of "trustworthiness" and the particular requirements of TTPR services, hardware and software systems, and management.

ISO/TR 17068:2012 has the limitation that the authorized custody of the stored records is between only the third party and the client.

ISO 17350:2013 provides guidance on

returnable transport items (RTIs),

identification codes used for RTIs,

specifications for two-dimensional symbols,

method for direct marking, and

reading method for direct marking.

ISO 16840-2:2018 specifies apparatus, test methods and disclosure requirements for wheelchair seat cushions intended to maintain tissue integrity and prevent tissue trauma. Test conditions simulate a symmetric anatomy and posture and do not represent cushion performance for specific individual users. Loads are intended to represent those seen under the pelvis of a 50th percentile wheelchair user and are not intended to assess the weight capacity of the cushion or to characterize the cushion under bariatric loads. It is possible that not all test methods apply to existing and future cushion technologies. It does not include test methods or requirements for determining the fire resistance of cushions.

ISO 16840-2:2018 can also be applicable to tissue integrity management devices used as other support systems, as well as to cushions used in situations other than a wheelchair.

ISO 16559:2014 determines the terminology and definitions for solid biofuels. According to the scope of the ISO/TC 238 this standard only includes raw and processed material originating from

• forestry and arboriculture,
• agriculture and horticulture,
• aquaculture

The specification defines a consistent set of measures and requirements for entities (e.g. organisations, governments, communities, families, individuals) to demonstrate carbon neutrality for a product, service, organisation, community, event or building.^[4]

The carbon footprint measurements should include 100% of Scope 1 and Scope 2 emissions, plus all Scope 3 emissions that contribute more than 1% of the total footprint.

The entity must develop a Carbon Management Plan which contains a public commitment to carbon neutrality and outlines the following major aspects of the reduction strategy: a time scale, specific targets for reductions, the planned means of achieving reductions and how residual emissions will be offset.

PAS 2060 requires that the total amount of carbon emissions at the end of a reduction period be offset by high-quality, certified carbon credits which meet the following criteria:

• From one of the PAS 2060 approved schemes (for example the Clean Development Mechanism, Joint I

ISO 17972-4:2018 defines an exchange format for spectral measurement data of inks to provide a means to characterise spot colour inks to allow reliable printing and proofing of products that have been designed using these inks. Only isotropic (paper-like) substrates are within the scope of this document, which is limited to application areas where the same ink and paper combination that has been characterised is used when printing.

ISO 17972-4:2018 describes the use of a CustomResource element within the CxF framework to define a minimum and recommended set of data for exchange.

ISO 17987-6:2016 specifies the LIN protocol conformance test. This test verifies the conformance of LIN communication controllers with respect to ISO 17987‑2 and ISO 17987‑3.

ISO 17987-6:2016 provides all necessary technical information to ensure that test results are identical even on different test systems, provided that the particular test suite and the test system are compliant to the content of this document.

ISO/TR 16056-1:2004 gives a brief introduction to interoperability of telehealth systems and networks, along with definitions of telehealth and related terms.

An informative annex describing the Telehealth Technical Reference Architecture has also been included to describe more clearly the various components of a telehealth system and the elements that need to be addressed in formulating a set of requirements for these various components.

The scope of the document does not include conformity and interoperability tests or functional specifications for telehealth systems and networks.

ISO/TS 17948:2014 defines the core set of TCM literature metadata, describes the principles and methods of TCM metadata, and specifies the formal description of TCM metadata. It applies to the storage, processing, recording, maintenance and exchange of TCM literature. It covers areas of identification, content, distribution, constraint, quality, maintenance, and relationship of traditional Chinese medicine literature.

ISO/IEC 17963:2013 describes a Web services protocol based on SOAP for use in management‑specific domains. These domains include the management of entities such as PCs, servers, devices, Web services and other applications manageable entities. Services can expose only a WS-Management interface or compose the WS-Management service interface with some of the many other Web service specifications.

A crucial application for these services is in the area of systems management. To promote interoperability between management applications and managed resources, ISO/IEC PAS 17963:2012 identifies a core set of Web service specifications and usage requirements that expose a common set of operations central to all systems management. This includes the ability to do the following:

This International Standard specifies a format for exchange of electronic document copies between computer systems. The format includes the definition of a GEDI Header containing information about the requester, Supplier, and format of the document and relevant bibliographic information.

This International Standard is applicable to computer systems supporting Interlibrary Loan and Document Transmission applications.

ISO 16087:2013 provides requirements for the clinical assessment of migration of orthopaedic implants with roentgen stereophotogrammetric analysis (RSA).

• Status :   Published Publication date : 2013-10
• Edition : 1Number of pages : 12
• Technical Committee : ISO/TC 150/SC 4 Bone and joint replacements
• ICS : 11.040.40 Implants for surgery, prosthetics and orthotics

ISO 17123-1:2014 gives guidance to provide general rules for evaluating and expressing uncertainty in measurement for use in the specifications of the test procedures of ISO 171232, ISO 171233, ISO 171234, ISO 171235, ISO 171236, ISO 171237 and ISO 171238.

ISO 17123-1:2014 is a simplified version based on ISO/IEC Guide 983 and deals with the problems related to the specific field of geodetic test measurements.

ISO/IEC 16963:2017 specifies an accelerated ageing test method for estimating the lifetime of the retrievability of information stored on recordable or rewritable optical disks.

The method is based on the theoretical assumption that the lifetime of data recorded on an optical disk has a lognormal distribution.

Detailed testing is specified for the following formats: DVD-R/RW/RAM disks, +R/+RW disks, CD-R/RW disks and BD recordable/rewritable disks. The testing can be applied to additional optical-disk formats with substitution of the appropriate specifications and can also be updated by the committee in the future as required.

This part of ISO 16063 specifies the instrumentation and procedures to be used for primary calibration of accelerometers using the reciprocity method and the SI system of units.

It is applicable to the calibration of rectilinear accelerometers over a frequency range of 40 Hz to 5 kHz and a frequency-dependent amplitude range of 10 m/s2 to 100 m/s 2 and is based on the use of the coil of an electrodynamic vibrator as the reciprocal transducer.

This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry.

This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event.

ISO/IEC 17998:2012 describes a framework that provides context and definitions to enable organizations to understand and deploy service-oriented architecture (SOA) governance.

ISO/IEC 17998:2012 defines:

• SOA Governance, including its relationship between Business, IT, and EA governance; this assists organizations in understanding the impact that the introduction of SOA into an organization has on governance;

ISO 16016:2016 specifies the protection notices which serve to prevent the improper use of documents and products whose usage is restricted.

With the benefit of a uniform text, protection notices draw attention to the existence of an industrial property right or copyright. Furthermore, they clearly show that the owner of the right claims legal protection to the fullest extent and, in addition to this, they restrict the utilization of the documents or products concerned.

No practice or source within a practice should be authorized unless the practice produces sufficient benefit to the exposed individuals or to society to offset the radiation harm that it might cause; that is: unless the practice is justified, taking into account social, economic and other relevant factors

Optimisation(ALARA):

All living things are exposed to ionising radiation from the natural (called background radiation) and man-made radiation sources. Ionising radiation may cause biological changes in the exposed person hence the doses to the occupational workers shall be kept As Low As Reasonably Achievable (ALARA) and doses to patients shall be optimized. Suitable control measures shall be employed to minimise radiation exposure so that maximum benefits are derived with minimum radiological risk.