This document applies to medical devices other than in vitro diagnostic medical devices manufactured
utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It
specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations
associated with such devices, to estimate and evaluate the resulting risks, to control these risks,
and to monitor the effectiveness of that control. Furthermore, it outlines the decision process ...
view more

    • sale 10% off
    • Standard
      37 pages
      English language
    • e-Library read for
      1 day

This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This...
view more

    • sale 10% off
    • Standard
      16 pages
      English language
    • e-Library read for
      1 day

This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately. The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A. Examinations of properties with results reported on a nominal or ordinal scale are not included. This do...view more

    • sale 15% off
    • Standard
      8 pages
      English language
    • sale 15% off
    • Standard
      9 pages
      French language

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 devices that do not come into direct or indirect contact with the patient's body.

    • sale 10% off
    • Standard
      52 pages
      English language
    • e-Library read for
      1 day

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 devices that do not come into direct or indirect contact with the patient's body.

    • sale 15% off
    • Standard
      43 pages
      English language
    • sale 15% off
    • Standard
      46 pages
      French language

This document defines terms used in the ISO 21043 series of standards.

    • sale 15% off
    • Standard
      5 pages
      English language
    • sale 15% off
    • Standard
      5 pages
      French language

ISO 18385:2016 specifies requirements for the production of products used in the collection, storage, and analysis of biological material for forensic DNA purposes, but not those consumables and reagents used in post-amplification analysis. The consumables and reagents covered by this International Standard include those used for evidence collection (sampling kits), such as swabs, containers, and packaging, and also products used in the analysis of DNA samples, such as tubes and other plasticwar...view more

    • sale 15% off
    • Standard
      19 pages
      English language
    • sale 15% off
    • Standard
      20 pages
      French language

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for ...view more

    • sale 10% off
    • Standard
      37 pages
      English language
    • e-Library read for
      1 day

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising ...
view more

    • sale 10% off
    • Standard
      26 pages
      English language
    • e-Library read for
      1 day

ISO 7405:2008 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. ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

    • sale 10% off
    • Amendment
      7 pages
      English language
    • e-Library read for
      1 day

ISO 22442-1:2015 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process f...view more

    • sale 10% off
    • Standard
      38 pages
      English language
    • e-Library read for
      1 day

ISO 22442-2:2015 specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1.
NOTE 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management...
view more

    • sale 10% off
    • Standard
      26 pages
      English language
    • e-Library read for
      1 day
    • sale 15% off
    • Standard
      1 page
      English language
    • sale 15% off
    • Standard
      1 page
      French language

ISO 7405:2008 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. ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

    • sale 15% off
    • Standard
      34 pages
      English language
    • sale 15% off
    • Standard
      36 pages
      French language

ISO 15195:2003 gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included. ISO 15195:2003 is not applicable to routine medical laboratories. The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. ISO 15195:2003 refers to the specific aspects of calibration laboratories in the f...view more

    • sale 15% off
    • Standard
      12 pages
      English language
    • sale 15% off
    • Standard
      12 pages
      French language
    • sale 15% off
    • Standard
      18 pages
      English language
    • sale 15% off
    • Standard
      19 pages
      French language
    • sale 15% off
    • Standard
      19 pages
      French language