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Superseded

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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Superseded date

09-30-2017

Language(s)

English

Publisher

British Standards Institution

1 Scope
2 Normative references
3 Terms and definitions
4 Essential principles of safety and performance
  of 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 (normative) - 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	48
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS ISO 16142-2:2017

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 7010:2011	Graphical symbols Safety colours and safety signs Registered safety signs
ISO/TR 24971:2013	Medical devices Guidance on the application of ISO 14971
ISO 14160:2011	Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
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 19054:2005	Rail systems for supporting medical equipment
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 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 690-2:1997	Information and documentation Bibliographic references Part 2: Electronic documents or parts thereof
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
ISO 3107:2011	Dentistry — Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements
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
ISO 22612:2005	Clothing for protection against infectious agents Test method for resistance to dry microbial penetration
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
ISO 22610:2006	Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Test method to determine the resistance to wet bacterial penetration
IEC 62471:2006	Photobiological safety of lamps and lamp systems
ISO 14969:1999	Quality systems Medical devices Guidance on the application of ISO 13485 and ISO 13488
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 23908:2011	Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
AAMI TIR49 : 2013	DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS
ISO 14161:2009	Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 23907:2012	Sharps injury protection Requirements and test methods Sharps containers
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 17664:2017	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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