This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical dev...
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    • Standard
      52 pages
      English language
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    • Standard
      52 pages
      English language
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This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptic...
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      21 pages
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This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicab...
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20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO-  under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019- Awaiting for  the assessment report E&Y Report

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1.1 Inclusions
1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure.
NOTE Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipmen...
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20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO-  under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019. Awaiting for assessement report from E&Y.
2018-10-17 - TAN : Lack of compliance

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This document provides guidance on auditing management systems, including the principles of auditing,
managing an audit programme and conducting management system audits, as well as guidance on
the evaluation of competence of individuals involved in the audit process. These activities include the
individual(s) managing the audit programme, auditors and audit teams.
It is applicable to all organizations that need to plan and conduct internal or external audits of
management systems or manage...
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      Slovenian and English language
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2021-04-26_JO: BT N 12459 and BT168/DG12120/DV to decouple from  Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulations 2017/745

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1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
1.2 This document is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization ...
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20200402JO- link to MDD,IVD, AIMD and M/023,M/252,M/295 removed. These links are included in the previous published version  EN ISO 15223-1:2016 - JT003045

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This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs).
...
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