New VDA 4: 2020, English version 2021 is avilable here.

 

11.040.01 Medical equipment in general

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immediate download
Released: 2013-05-31
DD ISO/TS 19218-1:2011+A1:2013
Medical devices. Hierarchical coding structure for adverse events Event-type codes
LANGUAGE
English
immediate download
Released: 1994-07-15
PD 6573:1994
Fundamental aspects of safety standards for medical electrical equipment
LANGUAGE
English
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Released: 1998-09-15
PD 6630:1998
Nomenclature system for medical devices for the purpose of regulatory data exchange. Rationale
LANGUAGE
English
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Released: 2020-08-19
PD CEN ISO/TR 20416:2020
Medical devices. Post-market surveillance for manufacturers
LANGUAGE
English
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Released: 2020-08-14
PD CEN ISO/TR 24971:2020 - TC
Tracked Changes. Medical devices. Guidance on the application of ISO 14971
LANGUAGE
English
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Released: 2020-06-19
PD CEN ISO/TR 24971:2020 ExComm - SET
Medical devices. Guidance on the application of ISO 14971
LANGUAGE
English
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Released: 2020-07-24
PD CEN ISO/TR 24971:2020 ExComm
Expert Commentary for PD CEN ISO/TR 24971:2020. Medical devices. Guidance on the application of ISO 14971
LANGUAGE
English
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Released: 2020-07-22
PD CEN ISO/TR 24971:2020
Medical devices. Guidance on the application of ISO 14971
LANGUAGE
English
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Released: 2005-12-12
PD CEN/TR 15133:2005
Nomenclature. Collective terms and codes for groups of medical devices
LANGUAGE
English
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Released: 2018-03-21
PD CEN/TR 17223:2018
Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
LANGUAGE
English
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Released: 2021-01-28
PD IEC TR 60601-4-5:2021
Medical electrical equipment Guidance and interpretation. Safety-related technical security specifications
LANGUAGE
English
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Released: 2019-05-13
PD IEC TR 61289:2019
High frequency surgical equipment and high frequency surgical accessories. Operation and maintenance
LANGUAGE
English