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16/30346073 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
Available format(s)

Hardcopy , PDF

Superseded date

30-09-2017

Language(s)

English

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Essential principles of safety and
  performance of IVD medical devices
5 Use of standards and guides in support of
  the essential principles
6 Essential principles and references to relevant
  standards and guides
Annex A (informative) - Rationale and guidance
Annex B (normative) - Table relating essential
        principles to standards
Annex C (informative) - Website listings of other
        standards suitable for the medical device
        sector and for assessment purposes
Annex D (informative) - Reference to the Essential
        Principles by International Standards
Annex E (informative) - Terminology - alphabetized
        index of defined terms
Bibliography

BS ISO 16142-2.

Committee
CH/210
DocumentType
Draft
Pages
50
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

ISO/TS 13004:2013 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
IEC TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
ISO/TR 24971:2013 Medical devices Guidance on the application of ISO 14971
ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
EN 13612:2002/AC:2002 PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
ISO/TS 19218-1:2011 Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes
ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
ASTM F 2761 : 2009 : R2013 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
IEC 62471:2006 Photobiological safety of lamps and lamp systems
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
IEC TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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